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TransCelerate BioPharma in the News Q4 2021

TransCelerate’s Member Company experts were featured in the press on a variety of topics throughout the last few months on a number of topics from data sharing to the ongoing pandemic. Read on to catch up on our latest news.

In September, TransCelerate commenced the development of an open-source reference implementation of a study definitions repository that will enable end-to-end data flow across systems within individual companies and across multiple organizations by partnering with Accenture, Microsoft, and the Clinical Data Interchange Standards Consortium (CDISC). TransCelerate is leading the effort to design, build, and deploy the open-source, vendor agnostic solution which can provide a common foundation for industry-wide interoperability. Microsoft will play a key role in solution architecture while CDISC will develop the technical and data standards employed by the solution. Accenture will support TransCelerate in leading the delivery and development of the solution that lives under the Digital Data Flow Initiative. You can find more information about this exciting new venture and how to contribute by reading the full press release.

The next few months saw changes across all organizations and industries, and most notably the retirement of Janet Woodcock, United States’ Acting Commissioner of Food and Drugs-Food and Drug Administration. Janet’s career at the FDA spanned 35 years as she tirelessly worked for the transformation of the way drugs are regulated and approved for market. Through her dedication she also advocated for the creation of TransCelerate to bring a concerted effort to R&D industry to identify and solve common drug development challenges.

One of the biggest areas of discussion in the scientific community this past year was surrounding decentralized clinical trials (DCTs) and making clinical trials more accessible for patients. The pandemic especially ushered in the need for changes in clinical trial operations to empower patients. TransCelerate was included in this PharmaVoice article as an organization that is working with regulatory agencies around the world to harmonize best practices and common nomenclature in decentralized clinical trials.

Want to read up on all recent news articles? Check out our News & Events page for a full archive of our media interviews.


Leigh Anne is the Communications Manager at TransCelerate Biopharma, Inc. In this role, she is responsible for all corporate communications, public relations, and marketing efforts on behalf of the company. This includes creating and executing public relations campaigns; maintaining and drafting content for blogs, newsletters, press releases and other internal and external communications; media relations; and planning conference strategies. Leigh Anne has over 15 years of experience and holds a BA in Public Relations from Susquehanna University.

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