At PMI, we consider our CRAs as ambassadors to our study sites. We rely on their judgment and skills to motivate and support study staff to execute their responsibilities on time and in a quality manner. Our monitors have an average of 10 years experience working on device, biotech and pharmaceutical studies across a variety of medical specialties/therapeutic areas.

We support our monitors with study monitoring plans and procedures, along with customized activity schedules, and online GCP tutorials oriented towards study staff. We utilize automated tracking systems to help them stay on top of subject enrollment and visit compliance, as well as IRB/Ethics Committee requirements.

Our monitoring process involves study oversight both at the clinical site and at PMI. Our monitors’ jobs are to confirm understanding of the protocol; detect protocol deviations; review relevant source documents, clinical study data, and adverse event reports; confirm product accountability and availability of other necessary study supplies; review and confirm maintenance of essential study regulatory documents; review patient enrollment progress; and confirm compliance with visit follow-up schedules.

Our Study Monitoring and Site Management services include:

  • Monitoring plan & procedures development
  • Pre-study site qualification visits
  • Essential study regulatory documentation maintenance
  • Source document review
  • Investigational product inventory management
  • Study supplies management
  • Study initiation site visits
  • Periodic site visits
  • Adverse event tracking/follow-up
  • Subject compliance tracking programs
  • Study close-out activities

 

 
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