Diego Nicolossi serves as an Associate Consultant at FDAQRC, where he leverages over 15 years of extensive clinical experience as a Biochemist and Pharmacist to enhance the quality and compliance of clinical trials within the pharmaceutical industry. His international background in Contract Research Organizations (CROs)...
Diego Nicolossi serves as an Associate Consultant at FDAQRC, where he leverages over 15 years of extensive clinical experience as a Biochemist and Pharmacist to enhance the quality and compliance of clinical trials within the pharmaceutical industry. His international background in Contract Research Organizations (CROs) has equipped him with a robust understanding of Good Clinical Practice (GCP) and regulatory requirements, making him a valuable asset in managing and auditing clinical trials across phases II-IV.
In his current role, Diego is instrumental in leading key projects that focus on optimizing clinical operations and ensuring adherence to regulatory standards. His responsibilities encompass performing as Project Lead and Lead Auditor, where he meticulously evaluates clinical processes and systems to identify areas for improvement. Diego's expertise extends to delivering comprehensive consultancy services, including the development of Standard Operating Procedures (SOPs) and providing strategic advice on quality systems and regulatory compliance.
With a strong foundation in data management and clinical supervision, Diego is adept at navigating complex therapeutic areas and ensuring patient safety throughout the trial process. His proficiency in electronic systems, such as Electronic Medical Records (EMR) and Electronic Trial Master Files (eTMF), enhances his ability to conduct remote auditing and streamline documentation practices. Diego's analytical skills and commitment to maintaining the highest standards of clinical integrity position him as a trusted consultant in the ever-evolving landscape of clinical research.