Clinical trials are essential to the success of new medical treatments and therapies. They help researchers study the effects of new treatments in a safe, controlled environment before these treatments are made available to the wider public.
However, running clinical trials can be expensive, time-consuming, and difficult. There are many different factors to manage, data to collect, and patients to monitor. This is why it's so important to develop standardized processes. Process standardization will drive efficiency as well as enhance safety and ensure compliance as you complete your trial.
In this blog post, we’ll discuss five tips that will help you standardize your clinical trial’s processes.
1: Document Protocols
Before you begin your clinical trial, it’s important to develop clear and concise protocols. Documenting what must be done when, by whom will ensure that end goals will be met in compliance with SOPs, charters and regulators. These will be the guidelines that you and your team will follow throughout the course of the study to ensure that it’s successfully completed on time.
When developing these protocols, your team should try and account for the goals of the study and the requirements needed to complete these goals. This document should outline the objectives of the trial, the eligibility criteria for participants, and the procedures that will be followed during the study for everything from recruitment to oversight to FDA application and review.
Begin with the end in mind! By laying this foundation at the beginning and developing a protocol upfront, you will be able to avoid potential delays and disruptions during your clinical trial.
2: Mapping Processes Is Key
Mapping out your clinical processes is key to standardizing them. By understanding the steps involved in each process, you can identify where improvements can be made and what needs to be done to streamline the process.
Additionally, understanding your processes can help you troubleshoot issues that may arise during a clinical trial. There are many benefits to mapping out your clinical processes. By doing so, you can:
Improve efficiency and quality
Reduce variation in how tasks are performed
Facilitate training of new staff
Make it easier to identify potential risks
Improve compliance with Good Clinical Practices (GCPs)
3: Optimize Data Management
One of the most important parts of a clinical trial is data collection, as the data will be used to determine the conclusions that the decision makers are able to draw from the study. But how to ensure that you’re providing all of the right information to the right people at the right time?
One way is to develop standard operating procedures (SOPs) for the collection, aggregation and dissemination of information to decision makers. SOPs outline the steps that should be taken during each stage of the clinical trial, from screening participants to closing out the study. SOPs also ensure that everyone working on the study is on the same page, as the standardized procedures are widely available to everyone. This can prevent miscommunication and eliminate incomplete data collection at different points in the study.
To further improve your data analysis, the data collected in your study can be aggregated into an integrated software platform like Cloud Concinnity. This will allow for centralized access to and control of information critical to decision makers at key trial stage gates. Cloud based, integrated systems allow you to centralized your research data in one place so research teams can access it whenever and wherever needed.
4: Leverage Clinical Trial Software
Managing the various components of a clinical trial can be complex and challenging,.especially when it comes to communicating standardized processes to the broader team and holding them accountable for adhering to those standards.
To help simplify this, it’s important to use clinical trial software that actually has a process management engine at its core. Process management engines eliminate the variability inherent in manual processes by automating them. By eliminating as many manual processes or point software solution bottle-necks as possible, you can create an environment where your team is more likely to abide by a standard process. Automating clinical processes improves efficiency and accuracy saving time and money and eliminating process variability that can put your study at risk.
Cloud Concinnity is purpose built to bring good process to clinical trial oversight. It offers unparalleled advantages to anything on the market today by centralizing, standardizing & automating oversight of key trial elements. Oversight teams need a single secure platform to support decision making at key stage gates to ensure quality, efficiency, accountability and control
5: Create a Budget and Follow It
Clinical trials can be expensive and time-consuming, and it’s easy for costs to get out of hand. That’s why it’s so important to develop a budget for your trial. An accurate budget should take into account expected expenses as well as costs of similar, previous trials to incorporate a historical basis of how much the study should cost. Expenses can range from participant payments, to research supplies, to software to help you track and complete your research trial.
By detailing all of these costs in a budget before the study begins, you’ll be able to avoid potential financial problems during your clinical trial. This will help to ensure that your study is completed on time and within budget.
In summary, developing the standardized processes for your clinical trial will help you manage all of the different factors of the study. And software like Cloud Concinnity can help your team manage these factors, collect data, and communicate effectively and easily. For a free demo of Cloud Concinnity, please feel free to reach out to us today. We’re here to help.