Transparency Life Sciences’ Trial to Assess Decentralized Data Collection
Transparency Life Sciences (TLS), a clinical-stage drug development company based on open innovation, announced that the first patient has been enrolled in an innovative ulcerative colitis clinical trial designed to assess the feasibility of replacing most conventional patient site visits with data collected using a combination of decentralized methods, including digital measurements, telemonitoring, remote video visits with clinical trial staff and blood collections by visiting nurses. In addition, the study is the first to allow key clinical endpoint assessments to be made by the subjects’ own gastroenterologists, rather than via designated sub-investigators affiliated with the trial.
The study was commissioned and is funded by a global biopharmaceutical company, and it is being conducted in collaboration with Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School, and a founding hospital of Partners Healthcare.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FSP Outsourcing in Clinical Research: Trends and Opportunities
June 9th 2025When drug developers choose the right outsourcing strategies in clinical research, they can gain significant benefits in terms of quality, efficiency, and operational success. In its third annual Functional Service Provider (FSP) Trends Report, Thermo Fisher Scientific’s clinical research business—PPD—gathered insights from 150 global biotech and pharma leaders to determine how FSP models help sponsors address common industry obstacles.
