As TransCelerate’s Member Company experts and initiatives rounded out the year, many were featured in the press on a variety of topics, including COVID-19, advancing clinical trials and collaborating with a new cloud data-sharing initiative.
Read on to catch up on some stories you may have missed.
The Continued Fight Against COVID-19
Last year proved challenging for biopharma and R&D companies as they raced to combat COVID-19. TransCelerate took aim at the pandemic through innovation and collaboration by designing and launching a new COVID-19 data sharing solution within our DataCelerate® platform. Through a combined effort between TransCelerate and the COVID R&D Alliance, 20 companies have joined the initiative, which allows sharing COVID-19 clinical trial control arm data in order to expand access to data and help to improve trial design in their own development pipelines. While this is a completely new venture of sharing patient-level data, TransCelerate’s COVID-19 data sharing platform is the first step in creating the right infrastructure for future adoption.
As the pandemic continued, it left countless challenges for healthcare and pharmaceutical industries as traditional methods for conducting clinical trials became difficult. The industry had to think innovatively about how to deliver new methods of care to patients during clinical trials. TransCelerate saw this as an opportunity to help solve some of the problems the industry faced. This meant mobilizing our Modernizing Clinical Trial Conduct Initiative to tackle these issues through data and experience to develop practical guidance to enable the success of solutions being implanted during COVID-19 into future ways of working.
But how do we harmonize clinical trial content in a post-pandemic world? Missy Heidelberg, senior product development industry collaborations and bioethics leader, Roche, and a contributor to TransCelerate’s Clinical Content & Reuse Initiative (CC&R) provided insight into this question of harmonizing clinical trial content to improve the ability to reuse data and content so that the biopharmaceutical community can leverage new opportunities in clinical trials. In this article, Missy highlights TransCelerate’s CC&R’s most recent release that supports content reuse and harmonization of processes. Through a series of templates produced by the CC&R initiative, researchers and authors can extract and reuse relevant data and content for submissions while enabling regulators and investigators to access important information within clinical trial documents with greater ease. The templates include a common protocol template (CPT), common statistical analysis plan (SAP), and common clinical study report (CSR) that can be used by all stakeholders in clinical research across all phases of studies.
Want to read up on all recent news articles? Check out our News & Events page for a full archive of our media interviews.
About the author:
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.