You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
In the fiscal year of 2017, the Food and Drug Administration (FDA) performed over 900 inspections through the Bioresearch Monitoring (BIMO) Program. Of those 900 inspections, approximately 70% of the inspections targeted clinical sites. Without a doubt, there is some prediction about when and where the FDA will announce inspections during the course of clinical trial, both from the sponsor and the clinical sites.
Topics: FDA Inspection, Brexit, CISST Algorithm
As Brexit negotiations continue between the UK and EU, clinical research sponsors are carefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to 597 trials in 2017, the numbers have diminished by over 25 percent. One medical research firm based in the US has halted its clinical trial activities in the UK due to the uncertainty in approval of medicines and acceptance of data by the European Medicines Agency.
Topics: Brexit