Clinical Research

Beaufort is a clinical research organization that provides a full range of clinical research solutions for pharmaceutical, in vitro diagnostics, medical device, and biologics companies. Beaufort has a proven track record in managing both domestic and international clinical studies from beginning to end, as well as providing strategic assistance at phases throughout a study.

Clinical Trial Monitoring

Beaufort’s talented contract Clinical Research Associate monitors demonstrate a passion for monitoring and a depth of complex therapeutic experience. Our monitoring services offer an additional layer of client support that goes beyond staffing, including frequent teleconferences with targeted agendas, regular face-to-face meetings with clients, and customized training emphasizing sponsor-specific rules of engagement.    

Services include:

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  • Case report form (CRF) design and development

  • Clinical site/investigator evaluation, qualification, and selection

  • Trial initiation and clinical monitoring on full range of visits in accordance with scope of work and GCP.

Quality Oversight

Beaufort understands that data integrity and patient safety are paramount to the conduct of clinical studies and essential to ensuring the most cost-efficient market approval for the sponsor. With the number of FDA warning letters to sponsors on the rise, it has become increasingly important for companies to ensure the compliance of their outsourced vendors.

Services include:

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  • Independent evaluation of the vendor CRO’s clinical trial monitoring process

  • Comprehensive, quantifiable analysis of high-risk issues discovered at sponsor clinical trial sites

  • Internal quality review of all reports to ensure the most accurate and complete assessment of the CRA and their adherence to the monitoring plan

Clinical Trial Management

Beaufort’s Clinical Trial Management services begin with the most qualified team of resources to service your needs. We can take full responsibility for a clinical study, from protocol design through submission of the study report, or we can provide one or more stand-alone services to complement your internal staff and other resources.

Services include:

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  • Study and protocol design

  • Clinical site/investigator evaluation, qualification, and selection

  • In Vitro Diagnostics and Medical Device Clinical trials