Clinical Safety
Experienced safety experts, embedded in your trial from set-up to close-out.
From early phase studies to large Phase III programmes, our clinical safety team works as an extension of yours, keeping your study compliant and your patients protected.
Our Clinical Safety Monitors act as a single point of contact for your team, investigator sites and study partners. They:
- Develop the safety management plan and coordinate safety monitoring
- Review safety events and manage expedited reporting, in line with international regulations and your in-house standards
- Keep sponsors, sites and project teams aligned
We work across a wide range of therapeutic areas and product classes. Our team, mainly qualified in medicine and pharmacy, processes cases consistently to EMA, FDA, MHRA and other requirements, in your safety database or ours, with at least a four-eye quality check on every case.
Our clinical safety services
Our clinical safety support covers three areas: case processing, safety reporting and safety database set-up. We can take on the full scope or just the parts you need, working in your systems or ours.
SAE and pregnancy case processing
Every serious adverse event (SAE) and pregnancy report is handled consistently, from receipt through to medical review.
- Case receipt and entry into the safety database
- Safety query management and site follow-up
- MedDRA coding
- Case narrative writing
- Medical review and reportability assessment
Safety reporting
We prepare and submit expedited and periodic reports, so regulators, ethics committees and investigators get what they need on time.
- Suspected unexpected serious adverse reaction (SUSAR) reporting and line listings
- Development Safety Update Report (DSUR) preparation and submission
- Aggregate safety reports
Safety database set-up
If you don’t have a safety database for your study or programme, we can provide one.
- A dedicated tenant environment, configured with the case attributes your study needs
- Direct sponsor access
- Listings and reports by study or by investigational medicinal product (IMP)
- Data migration
