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 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
Challenge: A company that offers comprehensive contract manufacturing services required regulatory support.
Beaufort Solution: The company needed a clear regulatory strategy for bringing their project to market in the shortest possible timeframe. In addition, the client needed clinical trial management and data entry to support a 510(k) submission to FDA. Beaufort provided ongoing regulatory consultation and conducted the clinical trials, including site identification/qualification, clinical study and regulatory document preparation, IRB submissions, site monitoring, and data entry in support of the company’s first 510(k) submission to FDA.
Challenge: 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 Solution: 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.
Challenge: A growing in vitro diagnostics company needed regulatory and clinical trial assistance for a 510(k) submission and a CLIA waiver.
Beaufort Solution: 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.
Challenge: The U.S. division of a global pharmaceutical firm needed support with clinical site field monitoring. Beaufort agreed to supplement the company’s full-time CRAs and contract monitors from a robust pool of qualified field monitors.
Beaufort Solution: Maintaining frequent contact with the client to stay abreast of ever-changing needs, Beaufort presents pre-screened and highly qualified candidates to the client’s management. This arrangement gives the client the ability to move forward with their field monitoring, knowing that their CRA pool can be supplemented with Beaufort field monitors across a wide spectrum of therapeutic areas and geographic locations. Beaufort’s flexibility, knowledge of monitoring practices, and our ability to deliver qualified CRAs in specific regions of the country has enhanced the client’s monitoring program and reduced travel costs.
Challenge: 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.
Beaufort Solution: 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.
Challenge: A small, innovative U.S. company requested regulatory support for submission of a 510(k) for a new medical device.
Beaufort Solution: The lack of internal expertise and infrastructure threatened this client’s ability to successfully achieve their business objectives. Beaufort was initially brought in for regulatory support, but as the project progressed, the client realized they needed assistance with clinical trial management as well. Beaufort created a collaborative environment to carry out the many responsibilities with the various partners in order to achieve the necessary results, including 510(k) clearance of this client’s medical device.
Challenge: A European company focused on the development of oncology vaccines needed assistance in planning for a U.S. IND, as well as a global Phase II clinical program.
Beaufort Solution: Beaufort designed an IND strategy that addressed the challenges facing an oncology vaccine, while taking into consideration the problems faced by other companies with similar compounds. Beaufort provided CMC support for the client’s manufacturing efforts. In addition, Beaufort consulted on and prepared the Pre-IND package for the FDA. The client received such a clear positive response to the package that a meeting with the agency was deemed unnecessary. This process facilitated the near-term development of their compound and led the way for the international Phase II program.
Challenge: The US subsidiary of a large, international pharmaceutical company needed assistance in preparing for several regulatory inspections.
Beaufort Solution: A majority of the company’s clinical and regulatory staff had never participated in a regulatory inspection and anxiety levels were running high. Beaufort began the project by interviewing all pertinent personnel to establish their experience level and determine the company’s preparedness for the inspections. Our work included extensive document reviews, mock audits, extensive training sessions, both seminar and one-on-one. Beaufort also developed white papers to share with regulatory authorities during the inspections. We developed a series of mock inspections and follow-up activities, and the client passed all regulatory inspections with minimal audit findings, including a major FDA pharmocovigilance inspection.