DLC assists clients in achieving compliance with US and European requirements for safety reporting in device clinical studies by offering the following services
- Centralized serious adverse event (SAE) reporting to EU Competent Authorities and Ethics Committees
- Clinical safety reporting to FDA
- Safety reporting plan for clinical studies
- Data and Safety Monitoring Boards and Clinical Events Committee procedures
- Client support for safety database set up
- Easy-to-understand guidelines for sponsors and investigators
- Training for sponsors and investigational-site personnel on recognising the types of clinical and medical conditions that could represent reportable adverse events.
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.