Clinical Research Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging diagnostic companies. The following case studies describe specific solutions that we have tailor-made for our diagnostics company clients.
The diagnostics division of a global top 15 pharmaceutical company engaged Beaufort to review their clinical trial protocol and to develop more cost-effective and efficient methods for managing their clinical trials. This was this division’s first use of an outside vendor to manage clinical trials in support of an FDA submission. Working closely with the client to obtain a full understanding of their processes, Beaufort created systems to manage the trials, combining the client’s operational procedures with our suggestions for system improvements. Clinical Trial Management included Site and Investigator Qualification, IRB submissions, Training, and Site Monitoring. Beaufort served as a conduit between the Sponsors and the clinical sites during the trial for communications and trouble-shooting to ensure necessary processes, documentation, and data collection were in compliance with GCPs.
A growing in vitro diagnostics company needed regulatory and clinical trial assistance for a 510(k) submission and a CLIA waiver. The company’s previous interactions with FDA highlighted a need for assistance in finalizing their clinical trial protocol, subsequent clinical trial management, and preparing for a pre-IDE meeting with FDA. Beaufort developed a comprehensive clinical trial protocol that provided the statistical power to support the intended uses. Beaufort prepared the company for interactions with FDA and meetings with the agency. Following these meetings, FDA supported the clinical plan which enabled the trials to move ahead and Beaufort located, qualified, and coordinated clinical trial sites for a highly time-sensitive trial.
A molecular diagnostics company developing proprietary nanotechnology to enable earlier detection and treatment of disease needed assistance conducting clinical trials in support of a 510(k) submission to FDA. Beaufort provided clinical trial management support, including clinical trial and regulatory document preparation, IRB submissions, and clinical trial monitoring support. This support enabled the company to make its first successful 510(k) submission to FDA.
A leading innovator in diagnostic and therapeutic products needed additional resources to manage three clinical trials in support of 510(k) submissions to FDA. The company’s products range from early detection and prevention of diseases to diagnosis, treatment, and treatment monitoring and this was the first time they had turned to outside resources to fill their needs. Beaufort developed a turn-key clinical trial management plan, beginning with site identification/qualification and essential document development for three separate clinical trials. In parallel, Beaufort performed a formal Risk Analysis Plan to ensure the project team was aware of the potential risks involved in performing three clinical trials within the very short timeframe required by the client. The plan identified potential risks, mitigating factors, and planned corrective actions if identified risks occurred. Beaufort initiated site identifications/qualifications and prepared the Project Operations Plan for the clinical trials.
