Clinical Site Monitoring and Training
NERI maintains both in-house and regional Clinical Research Associates (CRAs) trained in numerous therapeutic areas. CRAs perform a variety of clinical monitoring activities to ensure regulatory and GCP/ICH compliance for all studies. NERI CRAs work closely with the Program/Project Managers to ensure that clients’ expectations and deliverables are met or exceeded. NERI prides itself in developing strong working relationships with each investigative site in order to help build lasting and trusting relationships, leading to high performance.
NERI’s Clinical Monitors can provide all or a selection of the following services:
- Clinical monitoring plan development
- Site identification
- Site qualification and initiation
- Regulatory/study site documentation management
- Informed consent development
- Site payment management
- Investigator meeting coordination
- Site personnel training
- Clinical monitoring (interim, and close-out visits)
- Study procedures manual development
- Clinical study supply accountability
- Specimen/image management