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
Donawa Lifescience has also implemented an efficient procedure for remote monitoring visits. European harmonized standards for clinical studies with medical devices or in vitro diagnostics, as well as the US Food and Drug Administration allow and, in some cases, encourage the implementation of remote monitoring procedures. This flexibility is very important to improve the effectiveness and efficiency in monitoring and, as usual, the subject’s confidentiality has to continue to be strictly protected.
The procedure for conducting a remote monitoring visit is almost the same that of an on-site visit, with the only difference that the clinical monitor is not physically present on site.
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.