Study Activation and Site Monitoring

Pierrel Research provides Clients with a team of trained, experienced, locally and office based professionals that ensure fast study start-up , GCP site compliance, timely completion of activities, and successful conduct of protocols.

Pierrel Research CRAs are active site collaborators, able to forge effective relationship with Investigators and Sponsors, with a strong competence in:

• Understanding local regulatory requirements;

• Conducting and reporting Site Selection, Trial Initiation, Periodic Monitoring, and Close-out visits.

Pierrel Research CRAs are rigorously trained on ICH/GCP, standard operating procedures, ethical and quality issues, personal development.

Since 2008 Pierrel Research has introduced  HyperCRA, a sophisticated automated web-based database for tracking all monitoring activities within a trial. Through HyperCRA, CRAs plan and register their activities which are shared among all the Clinical Operations personnel.

HyperCRA allows to optimally monitor and distribute the CRAs’ workload, as well as to guarantee an efficient and quick management of possible unplanned requests of extra monitoring activities.

HyperCRA supports the Clinical Operations Department in CRA’s visit planning, and report tracking, measuring their effectiveness and compliance with suitable metrics.

HyperCRA can comply with different Monitoring Plans.