The Jon Block Group offers complete clinical trial protocol development for the regulated (e.g., IDE, IND) and non-regulated environment. Working intimately with biostatisticians and clinical trialists, effective protocols are designed to support corporate objectives, market needs, and regulatory requirements.
Much of the early success of our firm was based on developing academically-rigorous clinical trial protocols, and we continue this tradition with current clients as they navigate the often difficult regulatory processes both in the US and abroad. Our in-house team of expert clinical trialists remain well versed about ongoing debates and controversies on important methodological issues regarding protocol development and data evaluation. We maintain proficiency in all published clinical trial reporting guidelines including CONSORT, QUORUM, STROBE, STARD, and Cochrane.