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TransCelerate BioPharma Inc. Launches Second Year Initiatives, Expands Membership and Achieves Milestones for Original Projects
Date:11/7/2013

ites, institutional review boards (IRBs), and regulators. These protocols have become increasingly complex, as no agreed upon standards exist, driving up cost and time.  In addition, manual set-up of clinical systems based on non-standard "manual" protocols is time consuming, costly, and prone to error. Working with other industry stakeholders and regulators, TransCelerate seeks to standardize the format of clinical trial protocols and develop standards for required protocol endpoints, in alignment with the ongoing TransCelerate Clinical Data Standards project. This will simplify study protocols, facilitate data interpretation and enable down-stream automation of many clinical processes, increasing productivity and reducing costs.
  • Special Populations Clinical Trial Networks (Pediatric and Minority) – Presently, qualified investigators with adequate numbers of patients in these populations are difficult to find, and studies in these areas are typically exceptionally costly and lengthy. Especially in pediatrics, efforts to establish a network of investigators and sites are often repeated for each clinical trial and then dispersed after a trial is completed. With this initiative, TransCelerate, working closely with existing regional networks, will lead the development of global investigator networks for these populations which will result in accelerated development of new drugs or indications for children, adolescents and minorities as well as reduced clinical trial costs.
  • Investigator Registry – Clinical trial sponsors frequently invest significant time and resources in identifying qualified investigators and establishing study sites. The inability to obtain information on investigator sites' experiences and qualifications often delay crucial trials. TransCelerate's Investigator Registry will create a shared repository of investigator contact details and site-related data. This initiative builds on TransCelerate's Shared Portal Pro
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