Regulatory Support

Regulatory Support

We have the regulatory support

ProTrials can provide full regulatory review¬†and support for studies ranging in size from small, single site investigational studies to large, randomized controlled clinical trials – everything from domestic and international regulatory submissions to safety reporting. We also can just review track, and maintain your essential project related regulatory documents. ProTrials keeps abreast of all communications from the FDA and international regulatory agencies, including new guidelines and recommendations. Within ProTrials, we train our entire staff on revised or clarified regulatory information through company newsletters and seminars; we also update our internal SOPs and guidelines using proprietary templates, which are available for purchase by sponsor companies wishing to implement or complement their company SOPs.