One Simple Approach To Help Avoid An Unfavorable FDA Ruling

Regulatory bodies worldwide agree that regardless of who is running a trial or how the data is collected, the sponsor is ultimately accountable for data accuracy. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) sets global standards for every aspect of clinical trial conduct. In their governing documentation, ICH E6R section 5.2.1 details the relationship between sponsor and CRO. Yet, how can a sponsor control every aspect of the data without doing all the work themselves? The Remarque Systems platform provides a simple technological answer.

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