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Clinical Services

Document Preparation for Institutional Review Board (IRB)/Ethics Committee (EC) Review

IRBs/ECs are convened to protect the health, safety, and welfare of patients. Research involving human subjects may only be carried out if an IRB/EC approves the research plan. A central IRB/EC can provide economies in study oversight; if a central IRB/EC is appropriate for your trial, we can prepare and submit the trial application. If a trial site needs to submit to its own individual IRB/EC, we can help to support the site staff in preparing their application in order to make a timely submission. Our experience with hundreds of IRB/EC submissions gives us the insight to create documents that will meet the IRB/EC’s needs, to maximize the chances of getting a timely approval.