Theorem Clinical Research Releases the ‘Little Advisor,’ a Site-Level Reference Booklet for ISO 14155:2011 for Medical Device Trials

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Theorem Clinical Research released a site-level reference booklet that highlights the qualifications, regulatory/EC, informed consent process, CIP compliance, resources, training, device accountability, documentation and safety reporting for clinical research sites. Authored by Judith Köhnen and Dr. Lee Spurgin and illustrated by Michael Towse and Judith Köhnen, the booklet highlights the International Organization for Standardization (ISO) 14155:2011 requirements in an easy-to-read format.