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Theorem Clinical Research, a leading contract research organization that optimizes trial conduct, released a site-level reference booklet that concentrates on European (EN) International Organization for Standardization (ISO) 14155:2011.
The “Little Advisor for Sponsors” is authored by Judith Köhnen, MSc, senior project director of medical device development, and D. Lee Spurgin Jr., PhD, senior vice president and general manager of medical device and diagnostic development. The reference 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 easy-to-read booklet is available for purchase online.
“Our experience in managing complex studies for all classes of medical devices makes it possible to provide tools such as the ‘Little Advisor for Sponsors,’ ” said John Potthoff, Theorem president and CEO. “We view our clients as an extension of the Theorem team and want to ensure they have the necessary resources to succeed.”
Theorem brings together teams of clinical, regulatory and study management experts to provide innovative medical device development solutions and has the development and regulatory expertise to execute successful trials across all risk classifications and approval pathways globally.