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 ...

List of terms commonly used in clinical trial research. Glossary of Medical Terms in Lay Language Helpful list of medical terms described in lay language. Sample Study Startup Checklist Use this ...

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 ...

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.