On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP INSPECTIONS METRICS REPORT. This report covered the period from 1 April 2018 to 31 March 2019. The report provides excellent insight into MHRA’s compliance concerns. In this edition,
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
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018 and has been revised with industry comments. Section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the big, well-known EDC providers, to the small not so well known vendors, to homegrown EDC solutions only used internally by
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.
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
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
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