Clinical Trial Monitoring Services

Beaufort, LLC, provides uniquely qualified senior Clinical Research Associates (CRAs) with specialized areas of expertise on short timelines. Our network includes more than 200 contract CRAs worldwide with a minimum of eight years experience who are thoroughly vetted through our proprietary recruitment process. Highly qualified monitors mean low turnover rates and improved efficiency for our clients.

Recruiting Strategy

Our turnover rate is so low because our proprietary recruiting process is so intensive. All potential monitors are interviewed at least twice.

Our Recruiting Process Includes:

  • Thorough CV review to ensure specific minimum requirements are met

  • Comprehensive survey detail the candidate’s complete clinical background

  • Writing sample to demonstrate an ability to communicate succinctly and precisely while protecting sponsor confidentiality

  • Comprehensive survey detail the candidate’s complete clinical background

  • Debarment and NIDPOE check

  • Screen for personality traits identified as critical to a CRA’s success

  • Sponsor-specific screening questions

Beaufort’s monitors, located around the world to minimize travel costs, possess the highest degree of professionalism and a firm commitment to patient safety and data integrity.

They also must have:

  • A minimum of eight years field monitoring experience

  • Degrees in science or health-related area

  • Complex therapeutic experience

  • Experience managing multiple indications simultaneously

  • Proven record of ongoing GCP training

  • Flexibility to work part-time and full-time contracts

We make sure we choose the right CRA for each project. We would never place someone with experience limited to the pharmaceutical industry providing consulting services for your medical device clinical trial.

Monitoring Responsibilities

Clinical trial monitoring responsibilities include, but are not limited to:

  • Case Report form (CRF) design and development

  • Clinical site/investigator evaluation, qualification, and selection

  • Trial initiation and clinical monitoring to insure adherence to the scope of work and good clinical practices

  • Site management for multiple protocols and therapeutic areas

  • Investigator meeting attendance

  • Interim and final reporting

  • Resolution of all data queries

In addition to handling a full range of clinical trial monitoring responsibilities, Beaufort CRAs apply their in-depth knowledge of clinical research regulatory requirements, including International Conference on Harmonization (ICH) requirements and all Good Clinical Practices (GCP), to every clinical trial.

Beaufort CRAs are also trained to overcome potential obstacles between the trial site and the sponsor’s study team, working together to integrate data, processes, and outcomes.

CRA Support

Beaufort’s CRAs receive unmatched oversight and support to ensure they continue to provide the highest quality clinical trial monitoring

This Includes:

  • Customized training that highlights sponsor-specific rules of engagement

  • Weekly communications to promote a strong sense of teamwork

  • Regular teleconferences with targeted agendas

Unparalleled Client Support

Beaufort’s customized monitoring services offer an additional layer of client support that goes beyond superior staffing and sets it apart from other contract research organizations.

Beaufort Clients receive:

  • Comprehensive administrative management including monthly reconciliation reports and communications, schedules, itineraries, and timely submission of trip reports

  • Frequent teleconferences

  • Regular face-to-face meetings