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 implements efficient procedures for remote monitoring visits in compliance with European harmonized standards ISO 14155: 2020 and ISO 20916: 2019, as well as with US Food and Drug Administration requirements. This flexibility is very important to improve the effectiveness and efficiency in monitoring while keeping study costs under control.
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.