4 Critical Considerations for Clinical Trial Oversight

Researchers, sponsors, and CRO’s know that the time to think deeply about clinical trial oversight is before a trial starts, not after. We need only glance at the recent headlines about DSMBs to see how important it is to stay ahead of the curve. 

Boston Consulting Group has found that 70% of digital transformations end in failure, and that just 30% of companies are succeeding. So what does it take to make sure you and your oversight teams are in that top third? 

In this age where digitally enabled productivity gains are accelerating the fourth industrial revolution across industries, it means identifying and making critical changes. 

Here are the 4 critical considerations for your clinical trial oversight team to discuss today.

1. SHARED EXPECTATIONS & NORMS DRIVE CLINICAL TRIAL OVERSIGHT SUCCESS

Communication expectations and norms must be set for the DSMB and other stakeholders before the study begins. Especially in the emerging post-pandemic world where the rules are being rewritten for everyone, clear expectations are paramount.

This means getting involved, from the top and from the beginning, with how DSMB teams are interacting. Beyond the required protocols, is everyone who needs to be communicating already communicating? As the sands shift beneath our very feet, we all need to align around resetting norms.

2. SOFTWARE TRAINING & SUPPORT MUST UNDERSTAND CLINICAL TRIAL OVERSIGHT

As a smart software company, we believe in the power of technology. And because we know that shifting habits is hard, we believe even more in robust support and training. 

Researchers, sponsors, and CRO’s must ask: Does everyone on the DSMB know how to use the software? Have all support staff and experts been properly onboarded and trained? Does everyone know who to call if there is a software question? When shifting the habits and processes, ongoing support and training are critical. Make sure it’s set up in advance for your team.

3. PUT THE DIGITAL TRANSFORMATION ODDS IN YOUR FAVOR FOR REAL CLINICAL TRIAL OVERSIGHT

Boston Consulting Group has found that the majority of companies attempting a digital transformation fail. So what does this mean for the clinical trial oversight ecosystem? It means that the odds are stacked against us all -- unless we make educated changes. BCG has also identified the key factors for flipping the odds of digital transformation success in your favor, and they all deal with having a clear strategy that starts from the top, stays agile, and involves measuring and monitoring along the way. 

In the complex clinical trial oversight ecosystem, setting the right tone from sponsors, researchers, and CRO’s is critical, and that starts with the earliest conversations about the next study.

4. MEASURE YOUR RESULTS FOR BETTER CLINICAL TRIAL OVERSIGHT

To improve, we must measure. We all know this, yet it remains difficult to put into action. This simple paradox makes the necessity of ongoing and targeted outcome measurement absolutely critical for improving clinical trial oversight. 

The good news is that implementing a single, secure smart software hub will do both. It puts processes and protocols in place that will support better outcomes, and it implements automated measurement of outcomes that will make it easy to show just how much your DSMB is contributing to improved outcomes, from improved clarity of communication to rapid efficiency of creating reports and sharing data. 

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The time has already arrived for improved clinical trial oversight. The question is not whether it is possible, but whether you are ready to step into the critical considerations that will make the future of the clinical trial oversight ecosystem as good as it possibly can be. 

Let’s do this.

Talk to someone today about how your team can step into
the future of clinical trial oversight.

A Look Ahead: 4 Clinical Trial Oversight Trends That Will Guide 2022 and Beyond

The clinical trial oversight ecosystem is changing right before our eyes -- and fast. In an article titled The Next Normal Arrives: Trends That Will Define 2021—and Beyond, McKinsey calls out a range of shifts that will change the way we all do business. 

Which one should hit home for everyone involved in clinical trial oversight? 

Digitally enabled productivity gains accelerate the Fourth Industrial Revolution

We know that the fourth industrial revolution is already underway, as we are seeing the automation of business processes using modern smart technology all around us. Pair this trend with the understanding that remote work -- and especially remote committee meetings for oversight -- is here to stay, and a clear picture of a digitally enabled future for clinical trial oversight emerges.

So what does this mean for researchers, sponsors, and CRO’s?

1. CLINICAL TRIAL OVERSIGHT TREND #1: SMARTER SOFTWARE WILL DRIVE PRODUCTIVITY

Many oversight teams and committees are already using technology to some degree, and this trend will only continue. The big change? It’s that using these technologies -- especially smart software designed specifically for clinical trial oversight -- can rapidly increase the productivity of oversight teams. 

This kind of fast, relentless innovation is moving quickly for everyone. McKinsey reports that some executives are moving “20 to 25 times faster than they thought possible on things like building supply-chain redundancies, improving data security, and increasing the use of advanced technologies in operations.” Wow! This rings true based on the conversations we’re having with our expert advisory council and our clients as well. 

The time is now for researchers, sponsors, and CRO’s to have deep, meaningful conversations about how digitally enabled productivity gains are one of the imperatives of the new normal. 

2. CLINICAL TRIAL OVERSIGHT TREND #2: DATA SECURITY & INTEGRITY IS CRITICAL

As teams adopt new technology, data security and integrity is always top of mind. With new technology comes new rules and protocols all around. The amazing thing about this trend is that adopting mission-aligned smart software for clinical trial oversight will actually address productivity and data security at the same time. 

This means that adopting forward-thinking technology is part and parcel to adopting greater security. It also means that making these decisions is something that leadership needs to start thinking and talking about as part of conversations with every stakeholder involved. 

Whatever technology got clinical trial oversight this far is not necessarily equipped to help it grow into the future that is already here. The time for innovation and forward-thinking is here.

3. CLINICAL TRIAL OVERSIGHT TREND #3: NEW STUDY PROCESSES MATTER

The speed and efficacy with which the clinical trial ecosystem has developed vaccines and treatments for COVID-19 has been a marvel to watch. Clearly our clinical trial industry is able to move quickly and make incredible things happen while maintaining safety and oversight when we need these things most. McKinsey gives it to us straight: “The COVID-19 crisis has created an imperative for companies to reconfigure their operations—and an opportunity to transform them. To the extent that they do so, greater productivity will follow.”

Now the challenge is how to implement this kind of efficiency and productivity into the way all clinical trial oversight happens. How can we operate at our best every day and on every study? How can smart software support the highest and best use of the minds and efforts of our best science? How can automation and better, smarter processes help make great things happen? 

This is our task moving forward, and a critical trend shaping the next moves of the clinical trial oversight ecosystem.

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Whatever we were certain about a mere 2 years ago, it no longer holds true. Digitally enabled productivity and smarter remote work are the new normal, taking the clinical trial oversight ecosystem ever further. 

We’re ready to talk to you about the future of your clinical trial oversight.

3 Ways Smart Technology Improves Multi-site Clinical Trial Oversight

Large, multi-site trials are an important part of clinical trial research. They allow for deeper and broader research, while increasing the number of data points. Still, the scale of a multi-site clinical trial can, in turn, scale up the administrative and oversight challenges right alongside these benefits. We need only look to the Journal of Clinical Trials or industry whitepapers to see that challenges like communication, process, and data integrity are ubiquitous and ongoing. 

Today, we look at three key challenges for multi-site clinical trials, and how using smart, cloud-based technology for managing their oversight can improve effectiveness and impact.

3 Ways Smart Technology Improves Multi-site Clinical Trial Oversight

1. COMMUNICATION

 Instant, reliable communication is paramount to support quality clinical trial oversight, and this challenge is multiplied when there are multiple sites. Those at the site level are dealing with tremendous communication challenges already, and those challenges have the potential to bubble up to the oversight level. The DMC must be aware of these challenges and have tools to properly monitor the communication -- and have good tools and processes for their own internal communication. 

Indeed, the DMC needs its own robust, secure, real time platform for communication -- especially in the event of communication challenges or breakdowns outside of their control. For communication to keep up with a multi-site clinical trial, the oversight committees need a single, central, and robustly secure software hub. 

Smart software creates a channel for better communication.

2. DATA INTEGRITY

We know that for any multi-site clinical trial, there are many different software solutions managing many different things. This can be a source of challenges for the study. The Journal of Clinical Trials writes that “Researchers conducting clinical trials in multiple clinical sites with targeted populations face significant management challenges to maintain data integrity…” Oversight committees must be mindful of these challenges as they are reviewing data themselves and must ensure that the method and manner in which data is served to them maintains integrity, security and timeliness in order to safeguard patients.  

Creating a single, central hub for the oversight of data integrity provides a reliable channel for all data, whatever its source, to be checked in a standardized, formalized way. Even if patient data is being collected in different ways by different platforms and different people, it is being checked and overseen by a single, central set of people on a single, central platform. This reinforces the data integrity of every step of the clinical trial.

Data depends on a single home for efficient oversight.

3. STANDARDIZATION

Oversight standardization is equally critical. With a multi-site clinical trial, the oversight committee is dealing with the added challenge of standardizing the oversight across all sites. This can run into challenges if reporting information or processes is not standardized, or if protocols vary across sites. 

A recent whitepaper from Medidata calls out complexity of project management and collaboration as a major challenge for everyone in the clinical trial ecosystem, and added complexity means that the time and energy it takes to maintain proper oversight will increase in kind. 

The answer? Standardization of oversight processes and protocols. And while this answer may feel straightforward, it also shines a bright light on how integral a single, secure software hub can be for clinical trial oversight, especially in a complex multi-site study. 

Smart software supports smart oversight standardization.

Do your clinical trial oversight teams have the right tools for efficient, effective oversight?

Click here to access our essential guide to the future of clinical trial oversight

Choosing Clinical Trial Oversight Software? Here's What To Look For

Choosing the right clinical trial oversight software is critical. We need only glance at the damaging news cycles around vaccine development to see how high the stakes are and how slim the margin of error really is for communication, security, and speed. 

But, what is clinical trial oversight software? Why is it so necessary? And what distinguishes great clinical trial oversight software from the pack? 

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE SIMPLE. 

Clinical trial oversight software needs to create less work, not more. It needs to be simple to learn, simple to use, and simple to roll out. This means a great user interface and experience, plenty of helpful documentation, and ongoing support for administrators. Simplicity also means there should be less work for the admin because of the software, and less to remember for committee members, too. Look for smart software that uses automation.

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE INTEGRATED. 

In order to be a true one-stop-shop for oversight committees and administrators, clinical trial oversight software must be an enterprise grade integrated system that plays well with others. It must integrate with relevant clinical trial software that provides critical inputs to the work of the committees, such as eClinical data systems. It must also integrate with systems that rely on oversight committee information, such as eTMF software. Finally it must provide or integrate with standard productivity solutions such as document, signature, meeting and video conferencing management software. These integrations are powerful drivers of security, speed and efficiency in oversight work and communications.

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE SECURE. 

When we say secure, we mean airtight security that meets the highest possible standards. Truly secure clinical trial oversight software should meet the standards of a SOC 2 certification, use the highest level of data encryption, provide intrusion detection and breach monitoring, offer 24 hour continuous monitoring, and of course have protocols like access control and two-factor authentication. Patching together productivity software plus regular email and video chat is not secure enough to manage clinical trial data or communications. Great clinical trial oversight software will reliably protect unblinded data and reduce confusion in favor of clarity every step of the way.

CLINICAL TRIAL OVERSIGHT SOFTWARE MUST BE FLEXIBLE AND SCALABLE. 

Finally, clinical trial oversight software must flex to fit your operations in terms of scale and process. It should not only scale as your needs grow, but it should provide the operational leverage that allows your teams to do more. It should serve two or twenty members equally well, and also enable administration of one hundred studies as efficiently it does one. Key elements to look for include easily customizable, automated workflows that empower administrators and software with a development team who are consistently innovating and adding features in response to your needs. 

Are you ready to kick your search for the best clinical trial oversight software into high gear? 

Click here to access our essential guide to the future of clinical trial oversight

5 Signs Your Current DMC Software Is Outdated

Have you done a review of your DMC software lately? Has a review ever been done? Do you know who is responsible? Now is the time.

As Business2Community points out, using outdated software can cause a range of major problems, risking data loss through software failure, exposing your work to software bugs or cybercriminals, and leaving important work open to lost productivity through inefficiencies or sudden software incompatibility. The list goes on. 

We need only glance at Harvard Business Review to remind ourselves why “In the Digital Economy, Your Software is Your Competitive Advantage.” This is true across industries, and has become an urgent, necessary need for every stakeholder in the clinical trial oversight ecosystem. 

Is Your DMC Software Outdated? 

Here are 5 signs to look for. 

1. YOUR DMC SOFTWARE IS ACTUALLY MANY SOFTWARES COBBLED TOGETHER

Does your data monitoring committee use integrated software? Or, like most teams, are you patching together email, texting, video calls, and a variety of partial security measures that aren’t designed to work together? 

If your DMC software isn’t a single, secure hub, you are open to all kinds of security threats and inefficiencies.

2. YOUR DMC SOFTWARE MAKES ONBOARDING DIFFICULT

When you think about onboarding new members to your DMC, or writing a charter and starting with an entirely new data monitoring committee, how does your gut feel? Do you have that moment where you realize the new people will need to create multiple new accounts and learn new habits just to get started? 

DMC software that is all inclusive and holds everything a monitoring committee needs in one place is truly the only way to go in today’s asynchronous, remote working environment -- and it makes onboarding a snap.

3. YOUR DMC SOFTWARE IS SECURE… YOU THINK?

Who on your team can vouch 100% for the total and complete security of all data and communications related to your data monitoring committee? Not sure who? Not sure what that would even mean? 

That means your software and/or your process are dangerously outdated. It’s time to look for a comprehensive solution that is verified to the highest industry standard.

4. YOUR DMC SOFTWARE DOESN’T EXPORT THE FILES YOU NEED

It’s no secret to any DMC what files and data that sponsors, CROs, AROs, or even the FDA will need to review. So if the software your DMC is using doesn’t set everyone up for success by supporting the creation and tracking of those files, then how is it really helping you? 

Great, smart software is available and has come of age. If your software doesn’t export the files you need, it’s time to find one that does.

5. YOUR DMC SOFTWARE DOESN’T MAKE YOUR ADMIN’S LIFE EASIER

In the end, clinical trial oversight software should benefit everyone in the clinical trial ecosystem. But the DMC admin needs to love the software the team uses. If the admin isn’t saving time and seeing benefits to stakeholders every step of the way, why are you using it?

BOTTOM LINE: DMC software should deliver speed, scale and security, making everyone’s life easier. 

Ours does. 

Click here to explore why Cloud Concinnity is the best way
to update your DMC software. 

Beyond COVID: 3 New Standards for Clinical Trial Oversight

The Covid pandemic has impacted the entire clinical trial oversight ecosystem. What worked just a year or two ago will no longer get the job done. Clinical trial oversight committees need a new way to address complicated challenges like working remotely and asynchronously, and they need the right software to get things done efficiently and effectively.

It is time to be creative and innovative about how clinical trial oversight work is done so that it keeps pace with the rapid changes, pressures, and variabilities that are now part of clinical trial management.

Those who want to thrive in clinical trial oversight beyond Covid need to engage at a high level of speed, scale and security.

Here are the three new clinical trial oversight standards that we see as mandatory to thrive in the world beyond Covid -- and how we’ve already integrated these oversight standards into Cloud Concinnity so that forward-thinking teams who use our software can be sure they are prepared by default for the new normal.

The New Standards for Clinical Trial Oversight in 2021

1. FACILITATED ACCESS

Covid has changed how we communicate, and forever made instant communication the new normal. Oversight committees are expected to communicate much more often than in the past, and be able to access both data and each other anytime, anywhere.

The dynamic study ecosystem of today asks oversight committees to respond in real-time to new developments, news cycles and other stakeholder demands. Where traditional timelines saw periodic meetings to review data, the new normal demands 24/7 access and availability.

his new cadence means teams need to be more adaptive. The new nature of oversight calls for insight and innovation. We must put systems in place where all oversight committees and other key leaders can easily and securely communicate insight to sponsors and CROs. 

Cloud Concinnity does this with a single, secure hub that lives in the cloud. Wherever any committee member is, they can access data and each other as long as there is an internet connection. As an example, we prioritize secure online messaging and video chat, because that is how people work now. 

At the same time, this access must be carefully facilitated to ensure security for patient information, aggregate data, and communication records. Sponsors and CROs need easy-to-use, strict controls over who sees what data, who has access to what documents, and how information is stored. 

In short, you need facilitated access, not simply open access. That’s why Cloud Concinnity offers detailed, role-based permissions to allow deep customization. 

Click here to learn more about how Cloud Concinnity offers facilitated access.

2. CONTROLLED PROCESS

Just as Covid has changed where people work, it has also changed how people work. 

In-person meetings and a reliance on printouts are out, while online meetings and Zoom calls are in. We built Cloud Concinnity on this kind of cloud-based communication -- with the flexible and controlled process to go along with it.

The pandemic has already disrupted the entire clinical trial ecosystem, delaying or canceling almost everything. Even now, it continues to hamper, slow or stall trials for all kinds of new drugs and treatments. For any oversight committee dealing with a Covid-related drug trial, the pressure to move quickly is high. 

The only way for those trials to catch up is for the entire clinical trial oversight ecosystem to get more efficient, and the only way for that to happen is to create consistent, controlled processes that will change the way things are done. 

While some teams are dipping their toes into digitizing reports or using productivity apps, the only solution that solves the problem of how to effectively control processes is using a single, secure hub like Cloud Concinnity.

A shocking amount of time is attributable to administrative work at a time when such resources are increasingly scarce. This can be eased and minimized with smarter technology and automated processes. 

The new standard for oversight tech is to automatically track who has done what and when, making the work of admins easy, efficient and trackable. 

At the same time, committees and their work are subject to increasing scrutiny through regulatory pressure, auditing, and media attention. A platform that ensures, and documents, regulatory compliance and implements best practices is the tool of choice for those responsible for ensuring and overseeing compliance. 

Cloud Concinnity does all of this, and is built around controlled process. Automated processes mean more efficient interactions, consistent application of best practices and significantly reduced risk of delays, errors and noncompliance. 

Click here to learn more about how Cloud Concinnity supports controlled process. 

3. TRANSPARENT OUTCOMES

Finally, Covid has also changed what we all expect from each other and from our work. 

Not only do we expect quality, speed and scale from our businesses, but we expect flexibility and transparency from each other. Covid has pushed us all to become more adaptive and more creative. 

And to do that, we need reliable data to share with each other, and visibility to build insight on top of. Today’s clinical trial oversight committee members need reliable insight into what matters. 

This means a new level of transparency and accountability for all stakeholders in the clinical trial ecosystem. It means regularly updated, agreed upon performance metrics. 

And it means using software that offers a central dashboard, reliable analytics, workflow progress reports and audit-ready information all along the way.

Faster insights and faster action come from smart software that facilitates access for teams, allows admins to control processes, and wraps all of this innovation together with reliable, transparent outcomes.

Cloud Concinnity is always audit-ready and simple to export, interactions are automatically documented and available for review anytime, and everything is always up to date. 

Click here to learn more about how Cloud Concinnity delivers transparent outcomes.

IN CONCLUSION

Thriving in today’s clinical trial oversight ecosystem is not easy. But it is possible, and it starts by understanding the new standards for clinical trial oversight. 

Is your oversight committee strategy ready for the world beyond Covid?

5 New Ways Clinical Trial Oversight Practices Can Rise To Today’s Challenges

Today’s turbulent environment has precipitated an unprecedented level of pressure on sponsors, CROs, and the ecosystem of oversight committees needed to create and conduct a clinical trial. The stakes are simply higher now for every stakeholder involved in funding, managing and overseeing clinical trials.

The accelerated rate of change means that if these key stakeholders aren’t effectively engaging key issues of strategy and risk, they are competitively handicapped at best and, at worst, in risk of crises.

Taken together, these factors pose a serious threat to traditional practices of clinical trial oversight. Here are some of the old processes that are being challenged -- and how Cloud Concinnity can facilitate critical transformation.

1. ENGAGEMENT CADENCE

Clinical trial oversight historically followed a predictable, steady cadence of infrequent meetings. Certainly, there was no way for oversight committees to be in daily contact. Events that once evolved slowly now move much more quickly. Also, risks around safety and efficacy events aren’t so predictable.

Without platforms and processes in place to ensure oversight teams can communicate and engage outside the typical meeting cycle, leadership’s contribution becomes reactionary rather than proactive.

Smart, cloud-based software means that oversight committee members can stay updated and engaged anytime from anywhere. It’s the pace at which trials move, and the pace at which oversight must as well.

2. INFORMATION EXCHANGE

Many oversight committees are still relying on a multitude of sources and download points for information and documents to send information between sponsors, CROs, and oversight committees. An issue arises when such a glut of information is provided all at once, or when there is a sudden issue calling for action and comment and everyone involved needs to be on the same page right away. The predictable information asymmetry and lack of transparency will inevitably cause problems.

In short, if the committee is not regularly sharing information with each other, there can be a serious time lag for everyone to get up to speed and make important, urgent decisions that are well-informed.

We need only glance at today’s headlines to see what happens when clinical trial information is out of sync. This is the old playbook at work. An efficient method of information exchange is essential for everyone on the team to regularly share uptodate information with one another. It means all decisions can be better-informed decisions.

3. MANUAL PROCESSES

Clearly clinical trial speed and efficiency is more important than ever -- and requiring more time than ever. So why aren’t oversight committees equipped with the best task management tools to automate mission-critical processes?

While members can cobble together multiple tools for a small shot in the arm to efficiency, when they are not a single, secure hub enclosed in a protective layer of security they become more part of the problem than the solution. Automating what are typically manual processes adds a tremendous amount of value and makes the single hub a vehicle of tremendous efficiency.

4. TRANSPARENCY

Increased pressures have made it even more critical to quickly anticipate challenges and course correct accordingly. Sponsors and CROs have a responsibility to empower oversight committees to see and drive these corrections, and every stakeholder in the clinical trial process is increasingly under the microscope for its ability to do so effectively.

Without on-demand access to regularly updated data and performance metrics, stakeholders find it difficult to effectively fulfill their responsibilities. Cloud Concinnity's software is unique because it facilitates updates for all users in real time. Transparency is achieved through efficient information sharing.

5. RESISTANCE TO CHANGE

This isn’t a nuanced challenge: the fact is that many sponsors, CROs, and oversight committees are simply resistant to a new way of doing things.

With the rate of change in the clinical trial ecosystem skyrocketing, an unwillingness to keep pace puts patient health, study integrity and value creation in extreme jeopardy.

What’s more, in a competitive marketplace, it is the innovators who differentiate themselves and their market positioning, not those who are using the old playbook.

Cloud Concinnity allows stakeholders to be clear forward-thinkers and innovators in clinical trial oversight.

CONCLUSION

In today’s turbulent environment where sponsors, CROs, and the ecosystem of oversight committees are under immense pressure, the stakes are high for funding, managing and overseeing clinical trials. Old processes and playbooks must be challenged -- and changed.

Cloud Concinnity can facilitate the critical transformation and help clinical trial oversight rise to the many challenges of today.

Learn More About How Cloud Concinnity Can Improve Your Oversight

4 Critical Takeaways from AstraZeneca and its DSMB

News that a Data Safety and Monitoring Board (DSMB) overseeing AstraZeneca’s Covid-19 vaccine trial publicly challenged the company’s drug efficacy reporting has been a gut punch to the entire clinical trial ecosystem.

In a world clamoring for faster and faster vaccine development, we are seeing spectacular success in getting life saving drugs to market. We are also seeing a system pushed to its limits. Developing multiple safe, effective vaccines in under a year is incredibly impressive. Distributing hundreds of millions of doses is equally amazing. At the same time, the stress and pressure of moving quickly while also grappling with rapidly evolving communication requirements and procedural adaptations has introduced a host of new challenges at every point in the drug development process.

Critical independent trial oversight, the kind provided by DSMBs, historically progresses over months and years. That luxury of time to act, react and communicate more deliberately has disappeared.

Whatever the multiple and varied root causes of the current clinical trial crises are, they shine a bright light on what’s critical and essential in good clinical trial oversight. We are seeing in real time just how important DSMBs are. We are also seeing that communication and process norms that have worked for decades need to evolve, change, and adapt to the new normal.

Every clinical trial stakeholder who is involved in the regulatory and independent oversight committee processes, from sponsors, to CROs, to DSMBs, can seize this moment to look at communications, processes, and systems.

1. TAKE A HARD LOOK AT COMMUNICATIONS

It’s not the people. It’s the processes. It’s the systems.

The vast majority of people in the clinical trial ecosystem — researchers, sponsors and independent bodies — approach their work with high scientific and ethical standards.

Mistakes can easily happen when processes and systems for coordinating and documenting oversight are stretched too thin, or when oversight tools are decentralized. Today most DSMBs are forced to rely on processes and systems for creating transparency, communications and reporting that are fragmented inside and outside of their organizations. Administrators can find themselves at the center of rules, communications and processes that are not optimized for speed and efficiency and increase risk for non-compliance or miscommunication.

Without an integrated set of information and communication tools, it’s impossible to know the status of oversight committees or to audit effectiveness in uncovering research issues or unintentional process violations. It’s a real threat to otherwise tight clinical trial processes.

2. CONSIDER HOW STANDARDIZED PROCEDURES IMPACT TRUST & SAFETY

Standard Operating Procedures (SOPs) have a critical role to play for DSMBs and the overall process of clinical trial oversight. Whether born of the charter and study protocol, the safety plan, or other documented sources, creating and following SOPs is the road to safe, speedy trials that inspire trust.

The challenge facing DSMBs and administrators is not so much knowing or developing these operational best practices, but implementing, tracking and reporting on them. Too many studies are still relying on manual processes or using multiple software tools that aren’t designed to work together. The results of these kinds of disconnected solutions are not pretty, as we are seeing.

The depth and breadth of these challenges demand simplification, centralization and automation. What is needed is a powerful process management engine that can drive an integrated process and provide visibility into current status and historical actions.

What’s needed is smarter technology to provide a process management backbone for the independent oversight mechanisms. The future success of clinical trials is dependent on digital transformation. It’s time for the oversight part of the clinical trial system to be supported by software as powerful as the oversight committees themselves.

3. SUPPORT YOUR OVERSIGHT COMMITTEES WITH SMART SOFTWARE 

We believe in the power of smart technology to transform mission critical processes in service to a better world. Solving communication and process problems for oversight committees like DSMBs is our mission.

When we first launched Cloud Concinnity® as a governance, risk and compliance platform, it was used to solve a range of board and specialty governance management challenges. When COVID upended the world, it became the ultimate communication and process engine for DSMBs. We are passionate about helping DSMBs ensure patient safety while bringing life saving drugs to market.

Cloud ConcinnityⓇ takes the work of an oversight committee and creates repeatable best practices, then instantly reports the status of the work and provides a comprehensive audit trail.

Think of Cloud ConcinnityⓇ as an eClinical solution built on a robust, integrated, cloud based governance process management engine. It provides a single, secure hub to organize, coordinate and document the end to end activities of the DSMB.

Whatever the appropriate processes are for any trial oversight committee, here is how Cloud ConcinnityⓇ helps improve the execution, documentation and visibility of SOPs:

• SOPs for an oversight committee are broken down into tasks

• Tasks are assigned to individuals by their roles

• Execution of the tasks is tracked

• All actions within the system are logged

• Regular reporting of SOP status is visible as desired

• Comprehensive audits are available in seconds, since all work is in Cloud Concinnity

4. ACT NOW 

Today’s flurry of news is not just an urgent, pressing problem for the current round of vaccine development — it is a clarion call for every stakeholder in the clinical trial ecosystem moving forward.

Imagine the improved communications for DSMBs that begin using a single, secure cloud based hub to communicate. Imagine how clear and strong that message about the culture of respect and support for DSMBs will be sent. Imagine how sponsors can step up right now and show how fully they support their DSMBs by providing smart technology.

The problems flooding the news right now are preventable for those ready and willing to take action. Smart software solves communication problems. SOPs support safer, more trustworthy clinical trials.

We have the solution, ready to be deployed.

To learn more, explore our DMC & DSMB software.

For details, check out our Features & Benefits document.

Why Data Monitoring Committees are the Unsung Heroes of 2020

COVID-19 has made 2020 one of the most challenging years of our lives. In the face of unrelenting challenges, our healthcare ecosystem has stepped up in a major way, creating multiple vaccines in record time for a virus heretofore unknown.

What governments, researchers, clinical trial sponsors and managers have done is unprecedented. Vaccine development typically takes 10-12 years. Yet, we are seeing these vaccines come out in well under one year. While some of the factors that enabled this response were years in the making, we are are all benefitting from a herculean, cross-industry effort to mobilize resources and funding when it matters. Healthcare providers have risked their own health to test, treat, and now vaccinate us. A massive logistical infrastructure is adapting to produce and deliver millions of doses. The world is forever in all their debt.

We want to shine a light on a group of unsung heroes who have been integral and essential in developing these vaccines. Without their independent oversight, we would have no assurance of vaccine safety and efficacy. Without them, we would not have vaccines going into arms today.

We are grateful for their service and honored to support them.

What Data Monitoring Committees do & why you should care

We believe that Data Monitoring Committees are indeed unsung heroes of 2020 because they deliver the things no one else can: Trust and safety in new and innovative healthcare treatments.

DMCs are independent groups of clinical research experts, including physicians and biostatisticians, who oversee clinical trials. Their role is to monitor patient safety, data integrity, treatment efficacy and protocol adherence during a clinical trial. Importantly, they work autonomously of the people, organizations, and institutions conducting the clinical trial.

These DMCs are in place to keep patients in a drug trial safe. Responsibility for recommending that a study proceed, pause, be amended or end rests with these influential committees. If any safety issues rise up in the data along the way, the DMC members will recommend pausing or stopping. On the other hand, if superior effectiveness is clear early on, they may also end a trial early to accelerate drug availability.

DMCs also help move things along. Their work helps ensure that less time and resources are spent on trials with unpromising results, while expediting support for drugs that are are exceeding expectations to find approval and availability as quickly as ethically possible.

The work of the DMC is highly regulated and tightly prescribed. DMCs must provide documentary evidence of their activities. This documentation is a key part of regulatory approval submissions.

These little known specialty governance committees and boards are indispensable. If only people knew of them, confidence in drug safety and effectiveness, even when brought to market with incredible speed, would soar. So herewith, we shout out the DMC.

Our Passion for the work of the DMC

This year, we at the Concinnity Company have been in a unique position to watch as these little-known yet incredibly important groups of experts have shaped and protected global health.

As a cloud software company rooted in governance expertise, we saw early on how important smart software is for doing this kind of work efficiently, safely, and with total compliance and transparency.

As the world sped up and adapted in response to the coronavirus throughout the year, we adapted our specialty governance software to serve the unique needs of data monitoring committees.

We are proud to provide smart software for DMCs and support them in doing their critical work more efficiently, effectively and with reduced risk.

To learn more about how our software platform can serve your unique governance and oversight needs, click below.

5 Ways Smart DMC Software Will Power the Emerging Future of Clinical Trial Oversight

This year, COVID-19 has disrupted almost every aspect of clinical trial management and oversight. Research estimates that 80% of non-COVID-19 trials have been interrupted or stopped. The modifications to accommodate virtual and remote operations as trials resume are unlikely to be short term.

Trial managers are being encouraged to maximize all available technology to adapt. Likewise, the data monitoring committees providing oversight through all of this change, must also adapt. Streamlined processes and better tools will be imperative.

Dedicated and smart DMC software will power the emerging future of clinical trial oversight.

Chairs and Administrators need DMC software tailored to the communication, data, and security challenges of remote clinical trial oversight, and everyone on the committee needs easy-to-use, efficient tech that “just works.”

We understand these challenges, and when COVID-19 hit, we were ready. Our platform, Cloud Concinnity®, has been configured specifically for specialty DMC governance needs. It delivers global access, process management, and outcome tracking with certified security that is prepared to meet the exacting needs of this new era of clinical trial oversight.

Here’s how.

5 Ways Smart DMC Software Will Power the Emerging Future of Clinical Trial Oversight

1. Secure Document Sharing

   Cloud software is unique because all updates populate for all users in real-time. That means radically streamlined productivity, and allows DMC members to feel confident that they have 24/7 access to the emerging data, no matter where they are in the world or what time it is when they log in. Whenever any DMC member reviews data, they are reviewing the most up-to-date data available. Real time information updates and availability contribute to overall data integrity and support audit-readiness from end-to-end.

2. Simplified Scheduling

   One of the biggest challenges for DMC chairs and administrators, especially in the age of COVID-19, is managing everyone’s schedule. Smarter software eliminates countless emails and time-consuming delays by centralizing the scheduling process and automating many of the schedule alignment challenges that otherwise drag down our efficiency. In the end, it makes scheduling feel effortless for the whole DMC team.

3. Blinded vs. Unblinded Data Segregation

   Clear role-based permissions and workspace segregation mean blinded participants will never see unblinded data — it’s simply not possible. Built-in confidential data segregation replaces the time-consuming, manual management of sharing data to open and closed sessions or blinded and unblinded participants. This structurally eliminates the chances of compromising unblinded data.

4. Enrollment Data Tracking

   Because enrollment information can be easily updated across the platform a timely way, DMC members always see current enrollment data and are able to keep pace with the study as it evolves and changes. This means communication, data review, and decision-making all stay in step with the rest of the clinical trial, and nothing is lost or out of sync.

5. Automated Notifications

   Every benefit you see in this post is powerful on its own. Now add automation. Automated scheduling emails, automated meeting reminders, automated task notifications, and automated compliance documentation. With so much automation moving productivity and communication along, committees will find momentum in the mundane, and the ongoing interactions mean that when meetings happen, everyone is already up to date, making everything move that much faster.

In today’s clinical trial environment, data monitoring committees need superior DMC software.

Contact us now to learn more about how Cloud Concinnity can change things for your data monitoring committee.

How Smarter GRC Software Will Address the Emerging Digital Future of Boards and Committees

COVID-19 has deeply disrupted almost every aspect of corporate life. Boards and committees charged with governance, risk and compliance oversight have not been spared these dramatic shifts and are needing GRC Solutions. Much as the pandemic has changed how we work and live, it must also change how we think about and plan for a future decidedly more online. As global leader McKinsey & Company sees it, 2021 will be a distinctly digital year.

Now, more than ever, the important work of boards and special committees requires agile processes and cloud-based tools that can facilitate the work of these teams under any circumstances.

On the precipice of 2021, leaders must demand a cloud-based hub that delivers global access to all information, communications and activities, manages processes automatically, and simplifies outcome tracking. All with certified security that is prepared to meet the exacting needs of this new era of governance.

Here are the new table stakes for needed GRC Solutions.

How Smarter GRC Software Will Address the Emerging Digital Future of Boards and Committees

1. A Single Secure Information Hub

   In the absence of dedicated software for their work together, committees and boards have been forced to rely on cobbled together tools for document sharing, communication, reporting and activity management. The time, effort and expense to do this is massive. While necessary in a crisis, such solutions introduce significant risk over the long run. Cloud software is unique because all updates populate for all users in real-time. That means radically streamlined productivity for administrators, and allows all members to feel confident that they have 24/7 access to the emerging data, no matter where they are in the world or what time it is when they log in. Whenever any member reviews information, they are reviewing the most up-to-date data available. Having a single source of truth in terms of all information, communications and activities contributes to overall data integrity and supports reporting readiness from end-to-end.

2. Simplified Scheduling

   One of the biggest challenges for administrators, especially in an era of more frequent and unscheduled activities, is managing participant scheduling. Smarter software eliminates countless emails and time-consuming delays by centralizing the scheduling process and automating many of the schedule alignment challenges that otherwise drag down efficiency. In the end, it makes scheduling feel effortless for everyone.

3. Data Security

   Cyber risk is real. Using a collection of tools increases that risk. A robust single platform with clear role-based permissions and confidential data protocols minimizes confidential information leakage. Built-in security and data protection protocols replace the time-consuming, manual management of data sharing through unsecured connections. This dramatically reduces the chances of a data breach and minimizes the anxiety of sharing the wrong information.

4. Streamlined Decision Making

   When all information is updated across the platform in real time, members always see the most up to date information and understand next steps in real time, meaning everyone can keep pace with projects as they evolve and change. This means communication, data review, and decision-making all stay in step, and nothing is lost or out of sync.

5. Automated Notifications

   Today’s governance, risk and compliance GRC Solutions call for the smartest technology available. Process management, if not AI, should be embedded in these solutions. Features like automated scheduling of emails, automated meeting reminders, automated task notifications, and automated compliance documentation automate the routine so boards and committees can focus on the urgent and strategic. With so much automation moving productivity and communication along, committees will find momentum in the mundane, and the ongoing interactions mean that when meetings happen, everyone is already up to date, making everything move that much faster.

At Concinnity, we are motivated by making sure that boards and special committees have the smart software they need to power that future of adaptive and proactive governance.

When COVID-19 hit, we were ready. Our platform, Cloud Concinnity®, has been configured specifically for specialty governance needs, and we saw our users take advantage of those features in powerful ways.

In today’s uncertain governance environment, boards and committees need smart software. Contact us now to learn more about how Cloud Concinnity® can change things for you.

What If We Had Been Ready?

3 Pandemic Takeaways for Boards and Committees in 2021

In 2020, businesses and nations alike were thrown into the deep end.

The COVID-19 pandemic, summer protests, and the fall election season all happened on top of each other in a year of change and disruption.

How many of us were truly ready? What if we had been?

In their excellent pandemic response postmortem, Chris Tyler and Peter Gluckman argue that governments all knew that a pandemic was likely. Those caught flat footed were those who did not believe in the magnitude of the problem, were not taking the potential threats seriously, and were rewarding short-term thinking at the expense of long-term planning.

Bill Gates, among others, had been pointing to something like this since 2015. He even gave a TED Talk called “The next outbreak? We’re not ready.”

Some were ready for 2020, some were not. Those who were understood the imperative to think and invest differently.

Boards, committees and organizations that want to be ready for whatever change and disruption most certainly lie ahead, must embrace three principles.

3 Imperatives for Boards and Committees in 2021

1. Think Differently About Change

The pandemic happened suddenly — and also in slow motion. Businesses that weathered the storm well, like this list of Forbes’ top 25 corporate responders, were demonstrably agile, acting swiftly and decisively. They were people-based. They had already invested in digital infrastructure that could flex with the crisis. They had prioritized change management skills among people because they understood the need to manage long-term for continuous disruption.

And it paid off.

The kind of continuous disruption that the pandemic has brought is deep and will be ongoing, and it requires a fundamental shift in our mindset. Now is the time to embrace thinking that can flex with constant change, not a time to white-knuckle the year with one hand and cross your fingers hoping for normal with the other.

2. Operationalize Change Readiness

Planning for disruption must become a standard part of our day-to-day operations. People need tools and processes that support resilient, adaptive action-taking — and this means integrating the rhythms of remote work at all levels of organizations. Even after a vaccine, there will be no going back to how things were — there will instead be a new wave of change and disruption. Our growing pains can, and should, be the growing pains of a new preparedness.

McKinsey reports that “75% of people using digital channels for the first time indicate that they will continue to use them when things return to ‘normal.’” Adopting a new technology is never as simple as pushing a button. There is always a transition period. We need to make room for these adjustment periods, expect and prepare for them, and build resiliency and efficiency into how we adapt. People will always have to learn, and processes will always have to change. That takes time, and the failure to actively manage for these kinds of ongoing transitions impacts effective governance, efficient operations, livelihoods and even lives.

3. Invest in Robust Digital Assets

If your board or committee does not have a comprehensive digital solution, now is the time. The time for patchwork solutions is long over. We built Cloud Concinnity® in 2018 because we understood that boards and special committees needed smarter software.

When the pandemic hit, the boards and committees using our software were ready. They could immediately meet and connect, no matter where in the world they were, with 100% confidence in the security of their video calls, the integrity of all data and documents and the certainty of their processes. Whether for a corporation or a clinical trial, losing a step is never an option.

Our team has all sat on boards and special committees and advised governance leaders for decades. We know the weaknesses and the strengths of this kind of work. We built our platform to support the adaptive action that the change and disruption in the world demands from today’s boards and committees.

If you are ready to start 2021 strong with board and committee software as adaptive as you are, book a complimentary consultation with our team.

3 Secrets to Success in the New Normal for Virtual Board Communication

COVID-19 has changed everything. The shift to virtual work was happening slowly — and then all at once. 

When the pandemic hit, everyone hopped on conference calls, video conferencing, and productivity software, stretching these apps far beyond what they were built for.

We all did what we had to do to get through a sudden crisis.

No one was 100% prepared to deal with the jolt of COVID-19. 

But none of the apps people jumped onto were designed to support the kind of long-term, systemic business change that businesses need to tackle the challenges we are now facing.

If your leadership somehow had a crystal ball a year ago and could have built the perfect solution in advance, what would it look like? 

Imagine that next week, your leadership had a single sign in to communicate, share documents, manage activities and track their metrics in an elegant cloud platform.

Imagine if a month from now they could use that same app to host a virtual board meeting and all the information they had was already there. 

Imagine if everyone was seamlessly in sync when the calendar flips to 2021, rather than still scrambling to keep up with a patchwork solution. 

It’s possible. 

We are all 4 months into the reality of the pandemic, and there is no end in sight. 

It’s a new normal for the business world.

We need systemic, long-term change for high level business leadership. 

Here is what that looks like: 

1. New Systems, not quick fixes

We’re not solving one-off problems anymore — we’re solving the challenge of what work looks like in this new paradigm. Integrated cloud software is the only option large enough to handle the variety of needs any business is going to present. What we need is to reduce the number of software variables and security risks, effectively centralizing what we need to worry about — and where we need to do our worrying.

For example, software that makes video conferencing easier is good, but it’s not enough on its own. Leaders need something that holistically covers and supports everything they do — from day to day communication to document sharing. Cloud software platforms empower boards by working anytime, anywhere, and providing robust communication and storage capabilities.

2. Long Term Solutions, not short term 

No more whack-a-mole solutions. No more life preservers to stay afloat. Virtual work is here and it’s not going anywhere. 

We need software that is designed to support boards through the full cycle of board work. And that work requires a simple, central hub that gives everyone access to documents and each other, supports automated scheduling and reminder processes to keep things moving, and is equipped to track and report the outcomes everyone needs to make good decisions. 

3. Certainty & Security, not crossed fingers

Virtual board work done right makes things efficient and seamless. Done carelessly, it’s a security risk. The more texting and emailing you do, the more exposed you are to cyber risk. The more different apps you cobble together, the more chances for hacking you have to worry about. With a single, integrated software hub, you only need one wall of bulletproof security. 

We prioritize end-to-end security that allows every board member to share, chat, and browse safely and securely from any device. That’s something that cobbling together multiple solutions and crossing your fingers can’t do.

If your board needs a virtual solution built for the rigors of the new normal, we are here for you. Let us show you how you can simplify, centralize, and automate your work on a platform designed from the ground up for virtual governance. 

Click here to start a conversation with us.

The 3 Questions Your Leadership Must Answer During Quarantine

The 3 Questions Your Leadership Must Answer During Quarantine 

3 minute read

As the COVID-19 crisis upends business norms, we all must adapt. This new normal requires fast, effective decisions to be made by teams that are forced to do their work while far apart. When the only way to connect is digitally, we must do so intentionally and efficiently.

Here are three questions leaders must ask now to lead successfully during quarantine.

1. ACCESS: How are we providing decision makers with secure access to what they need?

The COVID-19 crisis has pushed almost everyone into remote work — and fast. Many leadership teams quickly jumped into using a mix of separate video conferencing, messaging and document storage apps or software. While this can be a good stop-gap measure, unfortunately, these kinds of patchwork solutions can also leave your team vulnerable to cyber-risk. So how can leaders have access to materials and communicate with each other in a secure way? 

Access in a virtual world is strongest when it lives in the cloud and brings together key functions under one umbrella. Using software that securely manages document storage, video and text communication means all levels of access are protected and streamlined. A recent publication from Stanford takes a deep dive into how leaders need broad access to make fully informed decisions, and we agree. That’s why we built software around the idea of full-featured, streamlined access. 

Cloud Concinnity® makes access simple and protected by putting information and communications sharing under the same security umbrella. 

2. PROCESS:  How must we adapt our processes to the world of remote management?

Changing routines during the best of times is hard. During a crisis is even harder. One of the biggest factors is preserving process control while and adapting to the virtual world. Much of what needs to happen is the same as it was before this crisis — but many of the methods for making it happen must change. The answer is for deliverables to be centralized and documented. Process that lives on a single, secure hub in the cloud.

Process can be a strong anchor for leadership teams. Process on a centralized platform places key steps front and center for everyone who needs to take them, baking efficiency into the way forward. When possible, having software that can automate pieces of that process can go a long way toward keeping the gears of leadership and governance moving — even when the people responsible are spread out.

Cloud Concinnity® controls and drives your key processes via a centralized leadership hub, adding to the umbrella of access. It makes replacing walks down the hall, meetings, spreadsheets and other ad hoc activity with software management tools a piece of cake. Pre-built, customizable workflows and tasks for the management of key activities ensures your team won’t miss a step. You’ll never go back, even after you go back to the office. 

3. OUTCOMES: Do we have a simple way to track and elevate key issues and outcomes?  

Tracking outcomes is harder when everyone is spread out and remote. When everyone was at the office, leaders had the luxury of walking down the hallway and asking for clarification. Now, they need to be able to click through and find out for themselves. Luckily, cloud software is exactly the right tool to do that. But for some reason, there are no other communication and process tools out there that also track results in a simple way. 

Outcomes on a single, at-a-glance dashboard seems like an obvious solution to us. Leaders need to a way to see what is going well, what is going poorly, and deep dive into what needs attention. So why are digital tools not built this way? We don’t know. We only know that we have solved this problem for you. And it won’t drive you crazy anymore. 

Cloud Concinnity® frames your outcome tracking on a single, secure dashboard for at-a-glance and audit-ready data. 

In Conclusion

Access. Process. Outcomes. 

We think software for making mission critical leadership decisions should do everything your leadership team is expected to do. Especially during quarantine.

Access to information, Process certainty, and Outcomes tracking. 

Cloud Concinnity® does what no other software out there will. 

Built by leadership and governance experts for high performance in any situation. Crisis included. 

Discover how Cloud Concinnity® can transform mission critical management & governance for your leadership.

5 Reasons Video Conferencing Apps Can’t Solve Your Virtual Meeting Needs

5 Reasons Video Conferencing Apps Can’t Solve Your Virtual Meeting Needs

3 Minute Read

Video conferencing programs might be fine for your book club or your virtual cocktails, but they are inadequate to handle the complexities of board and GRC management level engagement. And cobbling together video conferencing with other apps to fill in the capability gaps introduces risk, confusion, cost and delays into the whole process.  

The time for a full-featured software platform that puts power and speed in the hands of your leadership is here. We understand your problem. We have incredible software to solve it. We make getting up and and running a piece of cake.

Here’s why a central secure hub for your virtual meeting, information sharing, communications and outcomes tracking is a must-have. And why it requires less time, trouble and cost than you think. 

1. Video Conferencing Alone Isn’t Enough

While video conferencing beats audio-only calls every time, video alone is not enough. A full-featured software platform will support video conferencing with critical meeting management capabilities and a library of important documents so attendees all have access to every important document before, during, and after the call. Sharing, feedback, and collaboration features support critical ongoing communication between attendees as well. Streamlining and speeding up the transparency and follow through for next steps is more critical than ever. Having everything mission critical in a single, secure hub ensures end to end meeting process happens, even when you meet virtually. 

2. A Single Platform Simplifies Security

Cobbling together multiple apps to run meetings introduces both technical and operator error risks. In addition, each of these apps have their own security risks you must manage. With cyber-risk at an all-time high, bulletproof security is critical. A single integrated platform allows you to take control of software settings and sharing protocols to minimize technical and operator error risks. Securing a single platform and keeping up with the right settings is much, much easier when there is only one platform to manage, dramatically reducing the chances for hacking or operator error. Our own Cloud Concinnity® is SOC2 certified — a third-party certification that is the highest level of security certification available. The meeting management, communications, document management and performance tracking capabilities are safe inside our walls.

3. Centralized Communication is Faster

Cobbling together multiple apps also means participants waste time chasing data, communications and action items among an array of applications that don’t talk to each other and that maybe not everyone understands. Having everyone on your leadership team use the same platform to store documents, view analytics, exchange messages, track progress, and host your virtual meetings will streamline everything. A single, secure hub in the cloud beats jumping between a video call, a messaging app, a document app, and an email window every time. Your technology needs to be as integrated and able to reach across silos and departments as these new challenges are.

4. Automation Creates Efficiency

A full-featured software platform will not only run your meeting, it will run the activities before and after it. When actions and alerts are sent from the same platform where documents, meetings, and next steps are hosted, progress is streamlined. Software that keeps track of what needs to happen and when is especially valuable when people are all working remotely. Last minute changes or tasks are no longer a walk down the hallway. Smart software doesn’t care if you and your colleagues are on the same floor or have the same time frame or are on the same work schedule. Smart software puts you in the same virtual workspace, and knows how and when to get you what you need.   

5. A Master Dashboard Puts Everyone on the Same Page

Now more than ever, your team has to keep an eye on the same ball. Every day. In real time. What issues do you need to track as you lead and oversee your organization or mission critical process? How many places does that information live? How often does it change? How do key players know when it changes so they can do their part? A single, secure source for tracking issues and progress “truth” in real time is the answer. At-a-glance metrics make for rapid focus. Smart technology allows us to not only track and measure a multitude of metrics, it hosts and centralizes all the important numbers on one dashboard. 

Cloud Concinnity® powers everything listed above — and more.

Let us help.

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5 Tips for Mastering Virtual Meeting Leadership

5 Tips for Mastering Virtual Meeting Leadership

3 Minute Read

The future of your business depends on mastering virtual meetings. Step one is choosing smart software. Step two is managing the people and process elements of meetings.  

It’s not about “making it work” or “keeping up.” It’s about leveraging the virtual world to lead and govern even better. Here’s how.

1. Completely Rethink Your Agenda

In person meetings have a time luxury that no longer exists. Use time saved for meeting planning and preparing attendees for significant changes in pre, during and post meeting processes. Create tight, time-boxed, role/responsibility clear agendas that focus on dialogue. Cut presentations on matters that can be reviewed in advance out of your agenda. Be very clear about pre-work to all participants. Ensure that everyone in the meeting can view the agenda and all related documents simultaneously. Let tools that centralize and integrate documents, agendas and communications, metrics and deliverables make this easier for all participants. 

2. Don’t Let Technology Remove the Human Touch

Switching from in-person meetings to virtual meetings changes the dynamics, but it doesn’t change who we each are as people. Everyone is going through something right now, and everyone has a story to tell. Everyone is working through stress and anxiety. The way to lead is not to gloss over it, not to over-emphasize it, but to give it a place. Carve out a few minutes at the beginning of the meeting to check in, and be ready for both good and tough news. Speaking from the heart sets the tone and clears the way for everyone’s attention to be on the task at hand. Video conferencing is far better than audio conferencing for keeping the human touch.

3. Be Explicit About Virtual Meeting Roles

Virtual meetings require different roles and skillsets. Assign roles and responsibilities in advance. Confirm with the people taking on those roles beforehand. Designate a facilitator, a note-taker, and a time-keeper. The ability to use technology is now the equivalent of walking into the conference room and sitting down. Make that an explicit expectation. Assign responsibilities and timeframes for getting participants all along the process up to speed. But be realistic about current abilities. Know exactly what support resources your team needs. Get them. The return on investing in resources now to get your team working effectively will be high and the cost of skipping this is lower performance and increased risk.  

4. Short Cut Note Taking and Next Steps

In a virtual meeting, a good technology will offer the capability to share screens, split screens, or in some way display a collective record of what happened at the meeting. Notes and next steps can be shared, viewed, and confirmed by everyone in attendance before the meeting is over. Shared notes need not have every excruciating detail of the meeting. They should make explicit things like next steps and accountability, and be a record of decisions made. Use technology to get quick feedback post meeting, record votes, push and track next steps. Set clear expectations about post meeting roles and responsibilities. Stick to due dates. Use smart tools to control, measure and track key follow up items.  

5. Plan for Glitches

The news is full of stories about operator errors, technology glitches and bad actors crashing video calls. Know your technology and the capabilities of your participants. Meeting chairs and designated administrators must team well to master meeting facilitation in the virtual arena. Use waiting rooms and queueing features to view, vet, and start the meeting with grace and intention. Make sure the meeting host has researched and learned how to use these features well in advance of the call.

Your old normal can be replaced by a better normal. Cloud Concinnity® powers everything listed above — and more. Let us help.

Do you have the smart software solution you need to manage & lead in a crisis?

Cloud Concinnity® is a single, secure hub in the cloud for top of house leaders to centralize, simplify and automate what's mission critical. 

Find out how we can help you.

A Message from the Concinnity Company

Leading in the Time of COVID-19 & Economic Crisis

The impact of the Coronavirus (COVID-19) has been swift and severe. The actions necessary to slow the spread of the disease bring with them devastating economic consequences. 

Businesses are closing and business spending will drop. The consumer, who accounts for 70% of GDP in the US, has been sent home to face a future unlikely to make them spend while at home. A recession is just the beginning of what we can expect.

The kind of widespread disease we will likely experience is unlike anything that has hit most of the world since the Spanish Flu in 1918. Most economists now forecast unemployment north of 20% in the US, something not seen since 1929. A US deficit north of $3 trillion will be necessary for the country to win a war against an enemy that can’t be seen. 

All of this is forcing businesses to adapt overnight, almost every night. What seemed unthinkable yesterday seems like magically optimistic thinking today. 

There has never been a more important time for those at the top of the house to lead well.

I now spend much of my day gathering information and intelligence, including from investors, boards, and trusted advisors in a variety of industries, venture and finance, learning and advising on companies’ responses to the challenges ahead. It is clear that yesterday’s plan is insufficient to position our companies to withstand what lies ahead. Many companies have realized overnight their need for an efficient way for the top-of-house leadership to communicate, align, and execute mission-critical operations and oversight completely remotely.

Cloud Concinnity® was created to empower top-of-house leaders with smarter software, and that mission feels especially important right now. Our mission hasn’t changed. Cloud Concinnity® was built for times like these.

Why We Need Smart Software for Corporate Crisis Management, Strategy, Planning, Execution, and Communications

Just a few months ago, no one could have foreseen the massive impact the coronavirus would have on the world. But for Concinnity’s years in the making, we saw a pressing need for smarter software for the top of the house to navigate whatever the future throws at it. We knew world-class service would have to be a part of the solution. Our team and our software are here to serve.

Our customer success team takes calls from home on the weekend. Our development team is committed to maintaining the 24/7 uptime we have maintained since our launch. Our staff was already remote-work-capable, so our transition into remote work during social distancing has been seamless. 

This is a time to execute flawlessly like no other. Technology can keep us connected around tasks and to-do lists, and it can also keep us connected around our mission and values. It can make conversation and forward-thinking possible, especially in times of crisis. It can streamline processes when our teams and our thoughts are scattered, and it can provide clarity and transparency when the world is uncertain. In short, smart software helps make space for our best thinking during times of crisis. 

It is also a time to align. Our founding team has 100+ years of combined top-of-house leadership experience. We’ve built businesses, led companies, sat on boards, and navigated good times and bad from boardrooms and war rooms around the world. We know what it takes to lead during a crisis, and we built software that can deliver under pressure.  We offer our thought leadership, in addition to our transformative software, to assist you in the challenges ahead. Know that we are here for you. Call us and let us know how. 

Our countries and our economies will endure this crisis and come out changed on the other side. One big change we see is that top of house leadership teams will understand the need for strong, streamlined, integrated, cloud based communication — not just in a crisis but at all times. 

Stay safe, wash your hands, keep distances, and make room to look ahead. 

Yours in concinnity,

Nancy Falls

Click here to access our Corporate Crisis Management Resources

5 Ways to Make Your Virtual Board Meetings Great

Cloud Concinnity®: The turnkey software solution for your next board meeting and for end to end Board Management

The coronavirus is forcing businesses to adapt overnight. One of the biggest areas affected will be board meetings themselves. For the foreseeable future, these will be virtual. In the midst of the current crisis they undoubtedly will be more frequent. Top of house teams need a way to make them great and a cloud-based way to manage these governance processes end to end. 

With travel interrupted, staff working from home, and every day bringing changes to the new reality of doing business, it’s critical to move now to plan and execute your next board meeting in the cloud. 

Cloud Concinnity® is the turnkey software solution for end-to-end Board Management. Importantly for today’s environment, it was designed for creating, supporting, and implementing every aspect of board meetings online. Unlike any other solution, we had that in mind for you day one.

One shared hub, one shared goal. 

Here’s what Cloud Concinnity® does for you

1. Plan Your Virtual Board Meeting in the Cloud 

With staff working from home indefinitely, you need a central, secure hub to plan your next board meeting. This is not the time to leave mission critical oversight to the vagaries and errors of manual processes. This is not the time to cobble together a solution from multiple tools that aren’t designed to work together and are not secure.  

Cloud Concinnity® not only hosts all meeting materials, but all relevant information and communications. It keeps key players and support staff connected, and does so in a way that stays in compliance with regulatory requirements.

Cloud Concinnity® is designed for cloud planning and collaboration. You can manage alerts for meetings, content, reviews, signatures, and other updates from one dashboard. Roles based permissions keep communication and information flowing while keeping everyone in their lanes. Streamlined access, automated processes, and transparent outcome tracking every step of the way.

2. Run Your Entire Meeting in the Cloud

Hosting  all board materials and support documents (not just an online board book, but all the historical and support documents) is just the beginning of managing effective governance in the new environment. Cloud Concinnity® is your one shared hub, to execute on your one shared goal. Your entire board meeting can now happen in the cloud. 

Cloud Concinnity® supports video conferencing, agenda management, shared document viewing, online voting, and taking live minutes on a single platform, which is exactly the kind of power your virtual board meeting will require. No more ad hoc workarounds to communicate or to share and process sensitive corporate information.  

Real time board meetings, communication and information sharing in a dedicated cloud platform means staying effective in a crisis, not slowing down. 

3. Execute Next Steps Immediately from the Cloud

The next board agenda is going to have a fresh sense of urgency. 

Next steps will need to be centralized, streamlined, and tracked. Again, a cloud tool is the ideal workspace for top of house to make this happen because it is transparent and secure simultaneously. 

Cloud Concinnity® makes notes and next steps immediately transparent to everyone involved, and enables your team to bundle workflows with the documents on a single hub, then track progress. Your notes and next steps will act as action triggers, and the entire team will have visibility into who is responsible for what and how progress is coming along. Push notifications keeps everyone on track and on schedule.

4. Track Outcomes Right in the Cloud

Making outcomes trackable and transparent is more critical than ever. 

Cloud Concinnity®’s board scorecard tracks engagement over time. The company dashboard provides transparency & accountability at a glance. Because everything is centralized in the cloud, the top of house gets unprecedented insight into performance. 

Data shouldn’t hide. A single, cloud based tool builds outcomes into company-wide memory, which keeps momentum moving and top of mind. 

5. Operationalize Best Practice Governance for the Long Term

Cloud Concinnity® Makes Virtual Board Meetings Great, and your next board meeting is fast approaching. We can get you set up overnight for that and for the work to come.

Just turning on a conference call or webinar isn’t what you need for this meeting, or the next, or the long term or for the level of excellence you need.

Cloud based, institutionalized best practice governance is the new imperative for the top of the house. Turnkey Board Management Software is the solution.

The radical shift to remote work will persist long after the Coronavirus is in the rearview mirror. The profound changes in work, governance and risk management demand change for the long term.

The time for a patchwork solution is past.

The urgency of a cloud-based comprehensive system is upon us.

Cloud Concinnity®: The Turnkey Solution

In times of crisis, smart software solves problems — both expected and unexpected.

It should remove the barriers between top of house leaders, put an end to the inefficiency and risks of reinventing the wheel with manual process and workflows and eliminate scrambling for access or a password or wondering if you have the right version or asking someone to send you a document.

Smart software should centralize everything into a single hub, utilize integrated video, audio, and text, all protected with top level security. It should support staff and assistants by enabling the  building of processes once, operationalizing alerts and reminders to keep the board and senior management on the same page while working remotely.

Cloud Concinnity® is a comprehensive, turnkey workspace for top of house teams and mission critical processes. In a world where chaos is the new normal, leaders need to be agile and have the real-time intelligence to do great work.

Our founders have 100+ years of top of house experience between us, from the c-suite to the boardroom. We know what it takes to do great work in tough times. 

We’re ready to help.

Our CTO's Practical Advice on Working Remotely

Chief Technology Officer, The Concinnity Company 

We’ve seen a deluge of “expert” articles from consulting companies and established firms quickly adjusting to remote work. In my experience, these new-comers are the last people you should be listening to as they are making the same mistakes that companies who’ve done this for years can tell you to avoid. 

At TCC we are moving from 80% remote to 100%, so we’ve had a great head start and are happy to give you some practical advice. 

Practical Advice on Working Remote

• My dogs really distrust the Amazon guy, and loud barking is very distracting (much more so than the things in peoples backgrounds). If you get as many packages as we do, go ahead and put the pups somewhere out of earshot before you begin.  (@microsoft teams, @zoom please add a bark detecting - auto-mute feature). This also applies to cats on keyboards. 

• The top complaint of remote workers is that they are never off the clock. When your boss feels that you’re the same distance both on and off hours (just a message or call away!) they don’t hesitate to call. Either embrace the 24 hour work life. If your employee are answering emails / messages at 11pm, you can emphasize how dedicated they are and just accept that they are walking their dogs / doing laundry when you call sometimes. Or be strict and use applications that have ‘office hours’ built in. 

• Create a nonsense area, such as a “water cooler” chat group, in your messaging application where it’s encouraged and expected people will discuss out of work issues or general nonsense. Just because people are working remotely doesn’t mean they should be all business all the time. They need to build relationships and getting off topic is just natural. 

• Does your office enjoy sharing lunch time? With video chat, between the time delay, and not always looking directly at the person you are talking too, people often ask questions while you’re mid-bite. If you’ve ever tried to chew through a mouth full of food, while apologizing to everyone for having a mouth full of food, and also being 2 seconds delayed, it’s really awkward (0 stars, would not recommend). Try doing a shared coffee / drinks half hour instead. We like to start off just talking about which type of tea or 5pm beer everyone is trying at home.

• Get the software you need in place ASAP. If you don’t have messaging, task management and video chat all setup, call us! Remote is what we do, and how we work. 

And finally, here are some other people to learn from who know what’s up:

• Tech: Automattic (creators of WordPress) - A Crash Course in Remote Management

• Journalism: Momsrising.org - Working From Home with Kids

• Design: Invision – Remote Work for Design Teams

10 Steps You Can Take Now to Get Organized and Lead During the Coronavirus Crisis

There has never been a more important time to get organized and lead.

The impact of the Coronavirus has been sudden and far-reaching, and many businesses are not prepared for the long haul that this will be. 

Are you?

Work has moved online. The boardroom is now in the cloud. With work-from-home mandates and corporate travel restrictions in place for the foreseeable future, we are just beginning the work of managing the impact of Coronavirus on our economy and our lives.

Leaders need to guide their response from a single place. 

Cloud Concinnity® is the only comprehensive virtual mission control available that is designed around everything that top of house leadership needs.

Here are 10 Steps You Can Take Now to Get Organized and Lead During the Coronavirus Crisis

1. Embrace Long Term Crisis Management Mode

This is not a few days of travel delay. This is a marathon. This crisis is going to drag on. You need something built for the long haul, and we are just at the beginning. We don’t even know what this will look like as it develops, but we know this is going to hit us all hard. It’s going to ripple, and your team is going to need to get ready.

2. Begin Daily Planning Meetings for Coronavirus Contingency Planning

Your leadership is scattered across the country and likely working from home. The answer is not sporadic, long meetings. The answer is a daily virtual scrum where everyone on your leadership team can join a quick (virtual) morning huddle to explain what they’re working on and share resources, keeping everyone on the same page. 

3. Upgrade Your Leadership’s Software Platform

Dial in meetings are nowhere near enough. You need to see each other. Video conferencing alone will not cut it. You need to be inside a cloud platform that can hold all of your files. Virtual meeting software alone is not enough. You need workflow automation integrated so everyone stays on the same page between meetings. Remember, this is for the long-haul, not for a day or two. And because you’re leadership, you need the highest security protocols in place to protect proprietary information. One of the things that makes Cloud Concinnity® so powerful is that we offer comprehensive and secure document storage inside the same cloud platform as video conferencing, process automation and meeting documentation. You only need one tool. 

4. Get Everything Important Into The Cloud Now

Your leadership should be able to do as good of work from home as when they are in the office. The only way to do that is to get everything mission critical into the cloud, and make it available to everyone on your leadership team. With upgraded software, you can do that.

5. Make Your Virtual Meetings Great

You can’t cancel your board meeting - so what do you do instead? A comprehensive virtual mission control means everyone can be as effective and as present as they would have been in person. All the information they need in front of them. Totally secure. Logged and documented. And in a cloud platform that keeps everyone safe. 

6. Be More Efficient. Period

You don’t have time to not be efficient. Your distributed leadership team is even more distributed, and a crisis doesn’t wait. Using multiple software tools patch-worked together instead of a comprehensive solution means wasting time jumping back and forth between windows, fumbling for login information, and constantly asking each other where a certain file or message was. With Cloud Concinnity®, everything is always in the same place. Right where you need it.

7. Automate as Much Process as Possible

With everyone out of the office, the normal cadence of in-person “reminders” is gone. But you still need to keep your leadership team on track to sign documents, keep meetings, and generally stay on track. And everyone on your team is already stressed and operating in an unfamiliar environment from home. Make your software work for you by offering a comprehensive solution that lets your team automate workflows to reduce repetitive work and give everyone room to focus on strategy and crisis management.

8. Maintain Director Goodwill 

Proactively streamlining work during the crisis and quarantine period will help keep everyone calm and on track. The last thing you need is people squabbling about which version of a document to use, or forgetting the details that used to be routine, or unhappy grumbling that goes unaddressed. Meet early, often, and in a comprehensive way to keep your virtual mission control team on point and happy. And nothing keeps a leadership team happier than not having to scramble for their information.

9. Increase Engagement

While it’s easy to think that working from home or a canceled board meeting means less work and less engagement, this kind of crisis is actually cause for the board and senior leadership to meet more often. Shorter, more frequent meetings in the cloud mean everyone on the team can stay agile and mobile, but still focused from wherever they are. That means better decisions and crisis management. 

10. Learn From The Challenge

We will come out of this stronger than we were before. Leadership teams who root out and fix inefficiencies in order to navigate a crisis will find that there is no need to go back to those inefficiencies down the road when we are through this. Be aware, be nimble, and be ready to change. Learn from the challenge we are all being thrust into and get ready to come out the other side even better at what you do for your organization. 

Cloud Concinnity® is the only comprehensive virtual mission control available that is designed around everything that top of house leadership needs.

It is the solution for leadership teams to who need a way to work together efficiently and effectively to navigate the Coronavirus crisis.

We can get you up and running in 24 hours.

Our software offers a single secure control hub for integrated data, communications and process management.

And we are offering RAPID ONBOARDING for your board and senior leadership teams along with reduced onboarding fees.

It’s Time To Turn On Your Leadership’s Virtual Mission Control.

Or, call us directly.