How Technology Can Support Collaboration

This is part three in a series about how collaboration can impact TMF quality and inspection readiness.

In part one and part two, I discussed some steps organizations can take to foster a stronger culture of collaboration and accountability around TMF quality. In this blog, I’ll discuss the role technology can play in helping your organization achieve those goals.

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Technology has come a long way and can facilitate collaboration through several channels. It is important to note that technology is unlikely to replace people’s need to communicate with each other or automate operations completely. However, any technology system you may consider should allow you to achieve the following value across your organization and your study partners.

• Accelerate task performance. Make it as easy as possible for people to put data into the system and streamline complicated tasks as much as possible. Before, when TMFs were all paper based, moving to electronic TMFs accelerated the ability to find and categorize specific documents instead of searching through file cabinets for the right one. If the system is making tasks more difficult or taking longer, then the technology isn’t serving its purpose.
• Ensure everyone has the same information at hand. A technology system has no opinions or underlying objectives. By leveraging it as an agnostic source of truth, decisions can be discussed and made faster without worrying about egos or counter-fact arguments. Democratizing the data also speeds up processes, because time is saved by not bringing everyone up to speed before every meeting.
• Automate reports and alerts to keep people informed. Status updates, such as daily emails or alerts, should be automated from the system. Depending on the sophistication of your system, use reports to track completeness of your TMF and/or expected documents. This helps keep people informed without burdening them with tedious, low-value tasks of creating and sending these updates, thereby freeing up time for them to deal with complex or strategic issues.
• Distribute responsibility. Peripheral solutions may also play a role in making completeness more attainable more easily. For instance, consider a solution, like Veeva SiteVault, that helps sites them manage reg binders, review source content, and make content available to the sponsor or CRO monitors before electronically submitting it to the eTMF. The use and success of this type of solution requires collaboration from the sites, and the data creators must take ownership of the content going forward.
• Maintain accountability. Any system should track and report on what’s going on and what still needs to be done. Once this information is disseminated, the next steps should be evident and accountable parties should be expected to act. Rather than viewing it negatively, consider positioning the workflow as how all disjointed participants can working as a team, together for the success of the trial.

The general idea is to allow communication between study teams to be more strategic in nature, such as solving problems, building camaraderie, and increasing efficiency. Let the technology do the grunt work – the things that don’t add vault to the result but must be done.

Collaboration is an important component of successful trials because of all of the complexities that hinder a clinical trial. Everyone who’s part of a clinical trial deeply cares about the trial. They want it to be successful. Technology can empower success by letting people focus on what the real problems are so that the work can get done more safely and quickly. Technology can be a key part of ensuring a win for staff, organizations, and ultimately, patients.

Learn more about the urgent need to simplify information exchange for faster trials in the Veeva 2020 Unified Clinical Operations Survey Report.