In today’s ACT Brief, we examine how protocol-driven eSource is reshaping data capture at sites, how digital protocols and ...

Beyond sharing data, DQS aligns multiple data sources, including sponsors’ clinical trial management system data, public registries, and clinical trial databases, to provide a single, holistic, and ...

In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...

Method of treatment patents based on Phase II and Phase III clinical trial protocols are routinely pursued to extend patent exclusivity and strategically build a patent portfolio for a drug asset. The ...

A decentralized clinical trial (DCT) includes clinical trials where trial-related activities occur at locations other than traditional clinical trial sites such as hospitals and clinics. The Food and ...

Diversity in clinical trials matters for drug safety and efficacy—and for future medical advancements. Clinical trial ...

Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...

Objective To assess whether post-authorisation studies registered with the European Medicines Agency (EMA) adhere to legislation and recommendations to publicly post study protocols and results.