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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.

The Ugly Truth About Paper Diaries

Bridget Tyrka: May 14, 2019 4:12:21 PM

Although paper diaries may be familiar to many sponsors and clinical trial sites, traditional patient journals have the ability to invalidate otherwise reliable and valid clinical trial assessments. That unfortunate scenario can contribute to the ruin of multi-million-dollar clinical trials, depending on primary and secondary objectives as outlined in clinical protocols, which are the main objectives for clinical assessments of safety, efficacy and efficaciousness (Gupta, 2015).