For medical device and IVD projects, DLC site management and monitoring services include:
Site qualification visits
Site initiation, routine monitoring and close out visits
On site, remote and risk-based case report form (CRF) review/source document verification
Attendance to device implantation sessions in surgery suites
Hospital equipment/instrument verification and personnel training
Assessment of protocol compliance and protocol deviations
Monitoring of serious adverse event reporting
Site support, including routine telephone and e-mail contacts
Assistance to investigators in preparing required reports for the Ethics Committees / Institutional Review Boards
DLC clinical research associates (CRAs) have consolidated device experience and can access our team of medical or regulatory affairs experts throughout the project, so that any study-related issue can be addressed in a timely and effective manner.
Please contact us for further information or assistance.