NexusCRO provides comprehensive site monitoring and management. Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with GCP/ICH Guidelines and follows FDA/EMEA regulations. NexusCRO develops Sponsor-approved monitoring plan for each study. Monitoring visits are conducted at pre-determined intervals and/or as the study needs dictate.
Our CRAs are experienced in numerous therapeutic areas across drug, have state-of-the-art communications tools in place to provide timely and responsive communications, real-time data accessibility and centralized tracking and management of procedures.
Clinical Site Monitoring Services include: :
- Site Identification.
- Site Qualification and Initiation.
- Subject Accrual/Retention Strategy Enhancement.
- Regulatory Document Preparation and Collection.
- Budget and Contract Negotiation.
- Investigator Meeting Planning and Presentation.
- Site Personnel Training.
- Interim Site Monitoring.
- Clinical Study Material Accountability.
- Site Termination (averion).