In conducting clinical trials, it is important to demonstrate that individuals involved in the planning, conduct or reporting of clinical trials are appropriately experienced, qualified and trained in the specific procedures they undertake. This means for Start-Up companies, all employees involved in GxP activities have the necessary records in place to show they are qualified, experienced and trained. Like SOPs, gaps in training records, lack of training and access to training records are common findings during inspections.
For DArcy Consulting, development and roll out of Training is a key service offering.