Dr. Walovitch is chief medical officer of WorldCare Clinical. Prior to joining WCC, he served as the senior vice president of clinical research at Acusphere, Inc., vice president of preclinical and clinical research at Epix Medical, and research pharmacologist and project clinician in the Imaging Agent Group at the DuPont Merck Pharmaceutical Company. Walovitch has a doctorate in pharmacology from the University of Illinois Medical Center and a bachelor’s degree in biology from the University of Illinois. He is an author of more than 100 peer-reviewed publications, mostly in the field of medical imaging.
Regulators are primarily concerned with ensuring that all data is obtained independent from sponsor or imaging CRO bias and with minimal variability. Particularly important is the complete blinding of all clinical data provided to the endpoint assessment committee (EAC). The sponsor must be able to prove that all procedures adhere to pre-defined, study-specific guidelines that address the roles of all participating players (i.e. blinded primary and secondary readers, adjudicators, etc.) and document how exactly the EAC determined and adjudicated the outcome. Clear and explicit procedural directives are crucial. And just as in any other trial, they demand data accrued in compliance with good clinical practices, which means electronic back-up, minimal deviation from instructions, and a transparent audit trail for the entire process.