Clinical Research

4P Therapeutics performs clinical research in compliance with FDA Good Clinical Practices (GCP) and ICH guidelines. Clinical Research supports development of drug delivery products from early stage exploratory studies through pivotal trials. 4P has extensive experience in designing early stage clinical studies to evaluate drug-device combination products. In addition, 4P can leverage its dedicated Phase 1 clinical site to accelerate the path to proof-of-concept in humans.

4P can take a lead role performing all sponsor obligations or work with partners in a support role. Services include clinical protocol design, informed consent preparation, development of the investigator’s brochure, IRB submissions, Trial Master File maintenance, clinical monitoring, data management, medical writing, biostatistics, pharmacokinetic analysis and auditing.