Six of TransCelerate’s initiatives were featured in the news during the second quarter of 2022. These stories spanned our strategic priorities, whether it was in relation to patient-centric initiatives, those focused on data, or ways to improve a site’s burden. Read on for a deeper dive.
How TransCelerate is impacting biopharma R&D
Since the beginning of the year, TransCelerate has released 24 solutions to help biopharma R&D improve efficiencies.
Previously released solutions may not be the newest kid on the block, but they are still making an impact and are extensively used by those in the biopharma industry. In the article “How One CRO Uses RBQM in DCT Implementation” TransCelerate’s Risk Based Monitoring solutions were cited as a source used by the CRO Rho to develop its Risk-Based Quality Management Framework that aims to put patients first.
Another early TransCelerate solution, eConsent Framework & Implementation Guidance, was included in the MedCity News story “How Advanced Platforms for Informed Consent Can Reinforce Trust in Clinical Trials, Improve Compliance” as a resource to properly implement eConsent and other digital health tech in clinical trials.
Ken Getz, director and research professor at Tufts Center for the Study of Drug Development, recently authored an article for Applied Clinical Trials on “Quantifying Protocol Deviation Experience by Clinical Phase.” In this article, TransCelerate is included as a useful resource to help identify, classify, and manage protocol deviations. Our tools are especially important as the article notes that protocol deviations are the top cause of FDA inspection warning letters.
How to position clinical trials for success
This quarter also saw mentions of how TransCelerate is helping biopharma evolve into the next generation of operations. In “Cracking Down on the Rising Costs of Drug Development: How Pinpointing the Complexity of Individual Patients Can Improve Success Rates” our Modernizing Clinical Trial Conduct Initiative was included as an example of an organization using data and learnings from the pandemic to help enable decentralized clinical trials and make all trials more patient-centric.
The responsible use of clinical trial data was a core focus of TransCelerate’s presentations at the 2022 DIA Global Annual Meeting. Digital Health was in the audience for TransCelerate’s Real World Data (RWD) presentation and published our takeaways in “Why the Pharma Industry is Developing a Real-World Data Framework.” One of our newer initiatives, it aims to collaborate with global regulatory agencies to develop an RWD framework that defines tools, methodologies, use cases, and appropriate levels of evidence to support regulatory decision-making. In addition to the Health Authority Engagement Framework, the team is also creating an Audit Readiness Checklist that operationalizes best practices to aid quality management oversight of RWD. Both solutions are planned for release in late 2022.
Finally, one of our most popular solutions—the Good Clinical Practice (GCP) Mutual Recognition Program—was cited in the Clinical Leader story “Reducing Study Team Burden with Targeted Training.” A 2020 study conducted by CenterWatch reported that 80 percent of sites reported that administrative responsibilities had significantly or somewhat increased. By training with a provider recognized by TransCelerate’s GCP Mutual Recognition program, sites may reduce the number of hours spent on duplicative training verification.
Check back here in October for the round of our Q3 news stories.