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OmniComm and eClinical Forum Release Survey Results on ICH-E6(R2) and RBM implementation

Abby Abraham: May 23, 2019 12:15:00 PM

Changes to ICH-GCP requirements— in the form of ICH-E6(R2) — and adoption by regulatory agencies are expected to impact processes and operations in the clinical research industry. A new survey from eClinical Forum, in partnership with OmniComm Systems Inc., highlights the current state of implementation of ICH-E6(R2) and RBM in various segments of the clinical research industry.  The survey results pointed to a sharp divergence in implementing ICH-E6(R2) and adopting risk-based approaches to monitoring between large sized and non-large organizations.

Testing the RBM Waters — A Global Midsize Sponsor Weighs the Benefits of RBM Implementation

Sharon Rosenberg: Jan 9, 2019 12:28:26 PM

Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry. Due to limited financial and operational resources, smaller organizations face multiple challenges when adapting to rapid industry changes. A variety of factors contribute to the slower adoption of RBM in smaller organizations.