Clinical Trial Management

Beaufort, LLC, brings more than 30 years experience to the management of medical device, in vitro diagnostics, and early-stage pharmaceutical and biologics clinical trials.

We are committed to helping you accelerate medical innovation by delivering tested, successful solutions personalized for your trial.  We provide a comprehensive approach from protocol design to study report submission, or you choose from a menu of clinical trial management options that complement your existing work efforts.

Why Beaufort?

You have many choices when selecting a clinical research organization for your clinical trial management.  Unfortunately, many of the offerings begin to sound the same.  Beaufort stands above the rest for several reasons:

Depth of Experience

Beaufort’s uniquely qualified senior Clinical Research Associates (CRAs) are thoroughly vetted through our proprietary recruitment process.  Each has a minimum of eight years of experience and expertise in a specialized area.

Stability

Our CRAs stay with us for the long term.  In the past two years, less than seven percent of Beaufort CRAs assigned to active trials have left the company.  Compare us to a recent industry survey that found that 36 percent of CRO employees said they were considering changing jobs in the coming year.  Low turnover rates mean improved efficiency for our clients.

Strong relationships with the Food and Drug Administration (FDA)

Our seasoned senior regulatory professionals have been interacting face-to-face with FDA officials now for an average of more than 20 years.  We speak their language and our FDA consulting reflects that relationship.

Flexibility

Beaufort’s infrastructure delegates decision-making to the employees who the closest to the client.  This enables us to quickly respond to our clients’ needs – whether for new services, to troubleshoot existing trials, or to turn around new data and deliverables on a tight timeline.

Services include:

  • Study and protocol design

  • Case report form (CRF) design and development

  • Clinical site/investigator evaluation, qualification, and selection

  • Study management and coordination

  • Trial initiation and clinical monitoring

  • Medical/safety monitoring

  • Investigator meetings

  • Data management strategy

  • Database development and management

  • Medical coding, data entry, and quality control

  • Statistical analysis and review

  • Interim and final reporting

  • cGCP audits and training