Clario (BioClinica, Inc.) – FDA EIR, Feb 5, 2021

An FDA inspection was conducted at BioClinica, Inc. in Princeton, NJ, from January 19, 2021, to February 5, 2021. The purpose of this inspection was to assess the company's compliance with federal regulations governing clinical research and data management. As a result of the inspection, the company received a Form 483, detailing multiple significant observations. The identified issues spanned several critical operational areas. Concerns were raised regarding the company's organization and personnel, implying potential deficiencies in staff qualifications, training, or oversight. A notable violation involved the registration of studies on ClinicalTrials.gov, indicating non-adherence to transparency requirements for clinical trials. Further observations pointed to inadequate data collection and handling practices, which are fundamental for ensuring the reliability and integrity of clinical trial data. The inspection also highlighted issues with adherence to study protocols, potentially impacting the scientific validity of research. Additionally, deficiencies were noted in the management of electronic records and electronic signatures, suggesting a lack of compliance with regulatory standards. Finally, the company's record retention policies and their implementation were found to be unsatisfactory. These observations collectively indicate a need for BioClinica, Inc. to undertake substantial corrective and preventive actions to bring its operations into full compliance with FDA regulations. The company is required to formally respond to the Form 483, detailing how it plans to address each finding to prevent recurrence and ensure the integrity and quality of its clinical research activities.