At ProTrials, we have a department dedicated to ensuring sites have the appropriate regulatory documents completed prior to site initiation and throughout their participation in your study. This highly trained group can review and support studies ranging in size from a single investigational site to large, randomized clinical sites – both domestic and international. In addition to regulatory document review, tracking and maintenance services for your essential project regulatory documents can also be provided.
Through our global strategic partnerships, our experts can assist you with a full suite of regulatory support including submissions.
ProTrials keeps current on all communications from the FDA and international regulatory agencies, including new guidelines and recommendations. Training is continuously provided to our entire staff on revised or clarified regulatory information through company newsletters and seminars with internal SOPs and guidelines updated as needed.