Theorem Clinical Research Releases "Little Advisor For Sponsors," A Reference Booklet For ISO 14155:2011 For European Medical Device Investigations
8/21/2014 10:26:34 AM
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--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.
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