ProTrials is dedicated to confirming that sites complete the applicable regulatory documents (and have a fully executed clinical trial agreement) prior to site activation and throughout the study. Our highly–trained team reviews regulatory document packages for accuracy and completeness, and supports 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, we also file these documents in the electronic Trial Master File (eTMF).
Through global strategic partnerships, experts will assist you with a full suite of regulatory support including submissions to regulatory agencies. ProTrials is current on all communications from the FDA and international regulatory authorities, including new guidelines and recommendations. We provide training on an ongoing basis to our staff on revised or clarified regulatory information and ICH GCP guidelines.
