Services

Site Evaluation and Monitoring

We offer comprehensive site evaluation and monitoring services from feasibility through site close-out across North America, Europe and the META (Middle-East, Turkey and Africa) regions. Our monitors have 10+ years of experience on average along with excellent understanding of regulatory guidelines in their region. In addition to the responsibilities listed in the ICH GCP guidance, we believe in the involvement of our monitors in the protocol design and site feasibility processes so that factors such as study objectives, operational structure/hurdles and Patient profile are taken into consideration when the study timeline projections and monitoring plan are put together.

 

Industry Challenges

The business of clinical research is very diverse. Depending on Sponsor objectives and study needs it brings into play academic institutions, specialized units or commercial clinical research facilities located across all continents. The role of the monitor has evolved along with the increase in the complexity of clinical studies.

Capability Highlights

- Ready to use suite of relevant SOPs

- Thorough understanding of site operational structure and possible limitations

- Understanding of local ethical review process and its importance on timeline projections

- Comfort with geographic, demographic, linguistic and cultural particularities

Services

- Planning of Investigator meetings

- Site Evaluation visit or PSV

- Monitoring Plan development

- Site Initiation, Interim and Close-out visits

กค Essential document review
กค Investigator site file review
กค Source document verification (paper and eCRF as needed with options for remote monitoring)

- Comprehensive monitoring reports with action plans to mitigate/eliminate protocol deviations