Category: Clinical – Blog

Clinical CAPAs: Are Your Trials in a State of Control?

The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to believe that a quality system is not in a state of control. During inspection, we will look for evidence that

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Optimize Your eTMF Strategy

I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume 11, Issue 11). I wanted to give you in this blog a short glimpse on the main points addressed in

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Risk-Based Monitoring Improved

On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”. The sessions featured 24 speakers representing the FDA, EMA, large pharma, CROs/AROs, clinical vendors, TransCelerate, MCC, SCRS, and SCDM.

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Top 5 eTMF Features | etmf systems

Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to ensure regulatory compliance of data and documentation and ensure availability of study documentation throughout the trial and for years after

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Realizing the Benefits of Mobile EDC

Most every clinical trial today is utilizing some form of Electronic Data Capture (EDC). An EDC system allows for easier data collection, data checking and cleaning, and a real-time view into all data across the study. In most cases, clinical trial data are collected on

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Ennov Attends the SCDM 2017 Conference in Orlando, Florida

Last month Phillip Strickland and Mathieu Fourtillan from Ennov attended the Society of Clinical Data Management (SCDM) 2017 Conference in Orlando, Florida. The SCDM conference brings together hundreds of clinical data management professionals from all over the world for four days of educational sessions and

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