|Articles|January 25, 2018

A Clinical Research Reality: Standardization of R&D Outsourcing

It has been announced that steps have been taken in the standardization of R&D outsourcing. IAOCR and the Pharmaceutical Contract Management Group have taken steps to include a core competency framework for outsourcing managers and a training course, Outsourcing Essentials to develop these standards. Both organizations came together in common ground wanting to improve standards of best practice in the clinical research sector.

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Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.