;   Medical Translation Insight: A conversation about ISO 14155: Are companies struggling to comply? - ForeignExchange Translations

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.

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