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Exclusive Life Science Feature determine the prioritization and fit of the recently announced additional TransCelerate initiatives: (1) common clinical trial protocol template, (2) special-populations clinical trial networks (pediatric and minority), and (3) investigator registry. Gill provides an example of why linking current and future initiatives is not only important but logical. "One of the current projects involves developing data standards in collaboration with CDISC [Clinical Data Interchange Standards Consortium] and the FDA. If we are standardizing data for certain therapeutic areas, it makes sense to start tackling the front end of the process, which is the protocol for those therapeutic areas." This is why TransCelerate launched the common-protocol template initiative, which will match therapeutic areas with agreed-upon data standards for each therapeutic area. "Similarly, if you have a shared-portal platform, it needs an investigator registry that allows unique identification, credentialing, and identity management for clinical trial investiga- tors around the world," Gill contends. In my discussion with Gill, he revealed how his performance as CEO of TransCelerate is measured — delivery on announced initiatives, organization operations, and organization governance. When asked how it has been going thus far, he replied, "I think overall we have made really outstanding progress this year. We have delivered on the projects we said we were going to deliver on." Interestingly, about six months prior to writing this article, I was contacted by a reader proposing the submission of a TransCelerate "call-to-action" article. They expressed how TransCelerate wasn't moving quickly enough. While I have yet to receive a rough draft of the proposed paper, during the same time period, TransCelerate has delivered results on four of its five initial projects and added three new ones, as well. Perhaps all consortiums should aspire to move as slowly as TransCelerate. THE KEYS TO BUILDING A SUCCESSFUL CONSORTIUM For the founding 10 TransCelerate BioPharma companies, the benefits of membership were very clear (e.g. reducing redundant costs). In addition, the structure provides members the autonomy to select (if any) which initiatives to implement at their organizations. For example, a survey conducted by Industry Standard Research (see graph) reveals a variety of reasons to adopt risk-based monitoring, one of TransCelerate's initial initiatives. However, just because you are a TransCelerate member does not mean you are required to implement the outcomes resulting from every initiative tackled. According to TransCelerate CEO Dalvir Gill, Ph.D., this flexibility is just one of the keys to building a successful consortium. Adequate funding is another key. But at TransCelerate, it is not the type of funding you might imagine. "We are not an organization that is funded by a bucketful of money," he states. "Our funding is a fraction of a fraction of what funds many consortiums." TransCelerate's funding primarily comes in the form of time and intellect. "The member company defines a problem and then puts some of their best brains on coming up with a solution," he explains. Finally, Gill suggests another key to creating a successful consortium is to create it so that it can easily be dissolved when no longer needed. He refers to this as project sustainability. "My job as CEO is to plan for all of our projects to be sustainable with or without the existence of TransCelerate." However, given the number of projects currently being undertaken, Gill suspects the organization won't be closing its doors anytime soon. There could be many reasons to adopt risk-based monitoring. Which of the following do you think are increasing the adoption the most? Select all that apply. 75% 78% Cost Saving 51% 56% Improved Data Quality 43% Shorter Study Timelines 36% Access To Advanced Technology/ Analytical Tools Improved Patient Safety Increased Industry Attention/ Use Of The Model Improved Regulatory Guidance 36% 33% 35% Positive Impact On Site Relations Experienced Staff Other 28 11% 22% 29% 33% 22% 33% 20% 4% LifeScienceLeader.com 78% RBM-experienced (N=69) No RBM experience (N=9) 67% The TransCelerate member companies chose to focus resources on the most tangible projects that had enormous value and return on investment. Recent research by Industry Standard Research illustrates the perceived opportunity the industry sees in the adoption of risk-based monitoring, one of the TransCelerate project areas. Industry Standard Research — www.ISRreports.com January 2014