A recent report done by the European Medicines Agency (EMA) on good clinical procedures (GCP) found there were deficiencies around standard operation practices (SOPs). These deficiencies were found in monitoring, data management, and other documents for trials done in 2014. “Inspectors found a total of 673 deficiencies, compromising 30 critical (4%), 290 major (44%) and 353 minor (52%) for 2014.” These findings could have an impact on the life science industry and cause more programs to go under inspections.
To read more on the findings in EMA’s report, continue reading Zachary Brennan’s article in outsourcing-pharma here.