Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Theorem Clinical Research has released a site-level reference booklet that concentrates on European (EN) International Organization for Standardization (ISO) 14155:2011. The booklet addresses the scope of EN ISO 14155:2011, which is the equivalent of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) for investigational medicinal products and is commonly called the modern GCP for investigational medical devices for human subjects.The booklet also covers common terms and abbreviations, tips for categorizing adverse events, ethical considerations, responsibilities of the sponsor and advice on clinical investigation planning, conduct, suspension, termination and closeout. This booklet is available for purchase online.
Read the full release here.