A mid-sized medical device organization specializing in clinical research and development, operating as a subsidiary of a top 10 global pharmaceutical company, was actively engaged in conducting clinical studies in complex therapeutic domains. Simultaneously, they were establishing the necessary infrastructure for conducting global clinical trials, particularly under investigational new drug (IND) submissions in the United States. These trials involved the utilization of an approved, commercially available medical device in conjunction with a Food and Drug Administration (FDA)-approved drug.
To support their endeavors, Advarra Consulting offered a comprehensive suite of clinical quality services aimed at facilitating compliance with critical good clinical practice (GCP) standards. These services also entailed the assessment and mitigation of potential study startup risks and the identification of significant issues and concerns within clinical operations and the clinical trial management process. The ultimate goal was to provide a roadmap for corrective actions.