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Theorem Clinical Research Releases “Little Advisor for Sponsors,” a Reference Booklet for ISO 14155:2011 for European Medical Technology Investigations
(King of Prussia, PA; August 21, 2014) – 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 technology development, and D. Lee Spurgin Jr., PhD, senior vice president and general manager of medical technology 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 technologies 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 technologies 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 technology development solutions and has the development and regulatory expertise to execute successful trials across all risk classifications and approval pathways globally.
About Theorem Clinical Research
Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world’s top pharmaceutical, biotech and medical device companies. As a forerunner in medical technology and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry’s top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don’t think twice. THINK THEOREM.
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