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 ...

Researchers at The Hospital for Sick Children (SickKids), working with international collaborators and youth and family ...

In paediatrics, “more trials have been done over the last ten years, but we have struggled with transparency and clarity, and sometimes with the quality because they are not always asking the ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...

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 ...

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 ...

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 ...

When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...

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.