*仅作示意用近日，EMA发布了《药物临床试验质量管理规范（GCP）检查员工作组（IWG）2024年度报告》，该报告涵盖67次检查（52次常规、15次有因检查），涉及临床研究者（62.7%）、申办者（26.9%）和合同研究组织（CRO）（7.5%）等参与方，主要分布在亚洲（32.8%）、北美（25.4%）和欧盟/欧洲经济区（22.4%）。检查发现335项主 ...

The newly introduced AI-powered study build engine marks the first phase of ClinCapture's broader intelligent trial roadmap. By automating protocol translation, Captivate establishes a foundation for ...

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 ...

Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging ...

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 ...

Despite being a cornerstone of cancer treatment advancement, clinical trials remain inaccessible for many patients because of structural, socioeconomic, and systemic barriers. In this ...

Jonathan Andrus, co-CEO of CRIO, discusses how governance across the data lifecycle, site-focused technology adoption, and scalable AI-enabled workflows will define operational readiness in 2026.

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 ...

Researchers at The Hospital for Sick Children (SickKids), working with international collaborators and youth and family caregivers, have developed a child- and youth-centred global standard for ...