Activities to your needs
The sponsor can also select one or more activities specifically.
Legal
- Sponsor Representative in the EU
- Obtaining local insurance for patients and healthy volunteers and product liability
- Import of clinical trial study materials
- Preparation of the QP responsible material
- Liason with responsible persons and other CROs working on the project
- Ensuring ICH-GCP compliance
- Submission of product documentation, including protocol amendments to EC and CA
- Coordination of site inspections with the local authorities
Advisory
- Expert advice on EU issues
- Review of clinical protocols
- Management of the safety board
- Establishing Scientific Advisory Boards
- Performance of GCP audits
- Performance of GMP audits
- Performance of GLP audits
- Toxicological review
Medical
- Reporting, follow-up and documentation of serious or unexpected adverse events
- Initiation of urgent safety measures, as necessary
- Compiling and submitting annual safety reports and notification of end of a trial
Regulatory
- Regulatory liason with the EU authorities and CAs
- Information on modifications of local legislation regarding EU surveillance of emergency calls
- Monthly updating of status reports
- Establishing and maintaining database of adverse events
- Notification of any trial authorisation amendments