Patient safety is the very first priority
“Our Safety Management Team ensures that the safety of trial subjects as well as the safe use of investigational medicinal products are top priority”
Our experts have profound knowledge and experience in working closely with investigators, regulatory authorities, independent ethics committees, institutional review boards and sponsors.
Medical Monitoring is an integrated part of our Safety Management services.
Our medical monitors are involved in any safety-related matters throughout clinical trials.
They provide support and guidance for all study team members and sites who can rely on their medical expertise.
- Preparation of Safety Management Plan
- 24 / 7 Safety Desk
- SAE Management
- Data Entry in Safety Database
- Query Management
- Expedited Reporting (SUSAR Management) including Eudra Vigilance Reporting
- Annual Safety Reporting (DSUR)
- Participation in Data Safety Monitoring Board Meetings
- Medical Monitoring