When Will Paperless Clinical Trials Be the Norm?

07 June 2011 | Michael Naimoli, Worldwide Managing Director, Microsoft Life Sciences

​Will the data-intensive life sciences industry ever be able to completely move away from paper-based systems and simply manage content? I’ve been giving this topic a lot of thought after returning from the 3rd Summit on Clinical Trial Investigator Portals. At the summit, the hot debate was focused on the regulatory and process challenges involved in moving to paperless clinical trials.

Every pharmaceutical company with whom I speak is keen to move away from the inefficient and costly paper-based systems, especially when it comes to clinical trials. For good reason: Eliminating the time it takes to send paper copies of contracts, regulatory documents, protocols, etc. can help speed up the efficiency of the trial and ultimately the time to market. A pilot project conducted by the National Cancer Institute (NCI) and Bristol-Myers Squibb shows that using cloud-based IT instead of paper in clinical trials can lower costs. The NCI estimated that its clinical studies produced 100,000 pages of documents in 2010 alone.

As the clinical research landscape becomes increasingly complex thanks to consolidation and the globalization of research and trials, there is a growing need for a more strategic, technology-based clinical trial submission process. Still, moving to a new system in an industry as highly regulated as life-sciences poses some challenges. For starters, any content management technology needs to be secure, stable and scalable. Equally as important, it needs to be supported both internally and externally. It’s not enough to have a system in place internally if the clinical trial partners you work with can’t use it. If life sciences companies are ever going to ditch paper and move toward an integrated content management system, there needs to be industry-wide agreement on the technologies, standards and protocols and business processes that need to be in place. Basically, there is some risk to going 100% paperless. And if you are going to go paperless, it doesn’t necessarily benefit your organization if you just accomplish this within the four walls of your own company; consideration has to be given to the larger ecosystem.
In order to improve data exchange and foster collaboration, solutions should integrate with other applications, and seamlessly aggregate data from disparate sources into common, accessible formats. Solutions such as Microsoft Office SharePoint Server deliver a secure, web-based workspace that fosters collaboration and it is also compliant with the U.S. Food and Drug Administration’s guidelines on electronic records and signatures (CFR Part 11 criteria).
We have also partnered with solution providers to deliver intuitive, compliant solutions that allow users to collaborate real-time across borders while automatically capturing and uploading metadata stored within the document itself.
What is your organization doing to manage content more efficiently? What challenges are you encountering in the transition to paperless clinical trials? How are you working to ensure that partners can participate in the content management systems you put in place?
Michael Naimoli
Worldwide Managing Director, Microsoft Life Sciences