Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging biopharmaceutical and biologics companies. The following case studies describe specific solutions that we have tailor-made for our biopharmaceutical and biologics clients.

A European company focused on the development of oncology vaccines needed assistance in planning for a US IND, as well as a global Phase II clinical program. 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.

The US 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. 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.