Clinical monitoring and site management

All our Clinical Research Associates have experience across major therapeutic areas and have gone through a rigorous, comprehensive ICH GCP training program. They have constant and effective contacts with our sites, and perform monitoring during the study period, ensuring timely and qualitative data collection in a strict compliance with protocol procedures, SOPs and ICH GCP.

 

We provide a periodical professional training of our CRAs in ICH GCP, SOPs, Pharmacovigilance etc.

 

The services provided to our clients include:
- Investigator identification, selection and recruitment
- Evaluation of the Site qualification (pre-study visit) and site initiation
- Organizing the meetings for the investigators and monitors
- Ongoing site education on study protocol procedures, GCP and local regulatory requirements
- Clinical site monitoring and co-monitoring throughout the study
- Preparation of contracts, management of site /investigator payments
- Study document reviewing, collection and maintenance
- Management and constant contact with the site.
- Source documents verification
- Quality control
- Pharmacovigilance
- Drug accountability
- Query resolution
- Close out visits

 

During the course of the study our local (country) Research Coordinator (CRC) will keep you regularly informed about each of the critical project milestones.

 

ESMAR SOP’s, responsibilities and good communications within our clinical team ensure consistency in working processes across the project.