DCRC supports studies across a large number of clinical sites across southeast Michigan.
In order to facilitate multi-site studies for sponsors that require large patient population coverage, DCRC provides a centralized process of managing and monitoring sites with a robust IT infrastructure and a staff of highly qualified individuals. This enables sponsors to handle several sites at the same time with no incremental resource costs.
DCRC’s site management services include:
Site feasibility and qualification according to protocol requirements
On-site training for the investigational team and the study staff
Patient recruitment services using internal call center
Archiving trial documentation and quality control
Our Clinical Research Coordinators may follow either our own or the sponsor’s standard operating procedures. We can also use our monitoring plans and procedures, and GCP online training. Our monitoring activities involve feasibility and study site initiation, study development monitoring and study close-out at the clinical site. Our staff is trained to clarify protocol issues with the investigational team, handle protocol amendments, review the source documents related to clinical study data, report the advance events, and ensure patient safety and enrollment procedures.
DCRC’s services are conducted in accordance with ICH GCP guidelines and local regulatory requirements.
DCRC’s clinical monitoring services include:
Pre-study site evaluation and investigator assessments
Regulatory document preparation and collection
Budget and contract negotiation
Documentation maintenance and update
Site Initiation, interim and close-out site visits
Clinical study material accountability