Challenge: A leading innovator in diagnostic and therapeutic products needed additional resources to manage three clinical trials in support of 510(k) submissions to FDA.
Beaufort Solution: The company’s products range from early detection and prevention of diseases to diagnosis, treatment and treatment monitoring, and this was the first time it had turned to outside resources to fill its needs. Beaufort developed a turnkey 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 time frame 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.