Execution of FIH Study

Following regulatory approval, B4D can assist in all or select aspects of clinical operations to ensure the conduct of the clinical study adheres to the principles of Good Clinical Practice (GCP). B4D can identify qualified vendors through an RFP process and ensure the CRO selected is the best qualified for the study. Having previously worked in the therapeutic area, B4D can identify clinical trial sites through our network and work with the CRO on management of the sites throughout the conduct of the study. B4D also has preferred data management groups for all aspects of statistical analysis and data collection and management of clinical trial information. We also work with pharmacovigilance groups for the management and reporting of SAEs that may arise during the study. Throughout the process, B4D will use online management tools to ensure development milestones are met so that costly delays are not incurred at this vital stage of the product development process.