ISO 14155:2011 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials.
We recently sat down with Joy Frestedt and Pamela Wolff from Frestedt Incorporated, an FX Certified Partner, to talk about their work and the ins and outs of ISO 14155 and how it is impacting medical companies.
First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards.
With over 65 pages of detailed requirements, ISO 14155 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your companys' systems are compliant with every component of this global standard is complicated work.
For more expert insight, take a look at ForeignExchange's YouTube channel or jump directly to some of our past interviews:
- The human factor - interview with Maria Shepherd
- What's so special about medical device translation? - Andres Heuberger
- The changing landscape of clinical trials - Helen Colquhoun
- 5 questions about translation quality - Sonia Monahan
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Categories: clinical research