Execution of an accelerated proof-of-concept study presents logistical challenges including:

•    Dosing as many as three parts of the study simultaneously,
•    Recruiting patients for the proof-of-concept cohort of the study, while the first cohort is ongoing,
•    Coordinating clinical, bioanalysis, data management, and pharmacokinetic analysis so informed decisions can be made by the safety committee.

An experienced study team is required to successfully manage these challenges, with each member working closely with one another. At Cetero, we assign a senior clinical study manager to work with the principal investigator to monitor all clinical aspects. In addition, an experienced project manager is responsible for on-time and on-budget delivery of the core study components, including clinical, bioanalysis, pharmacokinetic analysis, data management, and biostatistics. Ultimately, this oversight ensures the accelerated proof-of-concept design decreases study time and reduces costs.