Clinical Safety Monitoring
Insource our Clinical Safety experts.
When and where you need them the most.
From Early Phase studies to large Phase III trials, our devoted colleagues contribute to guaranteeing effective safety monitoring during the execution of your trials. Biomapas’ experts help identify, evaluate, minimize, and appropriately manage risks to ensure patient safety during clinical trials.
Our Clinical Safety Monitors take responsibility for coordinating the safety aspects of your Clinical Trials and ensuring high-quality conduct, documentation, and reporting following industry regulations and your in-house standards. They seamlessly extend your clinical team and the on-site single-point-of-contact for internal and external stakeholders.
- Coordinating safety monitoring activities
- Review of safety events
- Coordination with project staff
- Communication with the sponsor, investigator site staff, and study partners
Raising The Bar For Safety.
In Clinical Development.
A complete solution for Clinical Safety
Biomapas’ experts can provide clinical safety service in a wide range of therapeutic areas and product classes, from clinical safety set-up to continuous surveillance and study close-out activities.
Our experienced team can also support fast, reliable safety management plan development and smooth execution. If needed, we can provide efficient safety database set-up, including individual tenant environment set-up, specific case attributes and data migration.
Our expert team members, who hold degrees in mostly medicine and pharmacy, maintain consistent case processing in line with all EMA requirements while recording cases in your Safety Database with at least four-eye quality checks and assessments.
Clinical Monitoring Activities
- Adverse Events (AE)/Serious AE (SAE) processing;
- Recording in Safety Database;
- Query management and follow-up;
- MedDRA coding;
- Case Narrative writing;
- Medical data review;
- SUSARs handling;
- DSUR preparation and submission;
- Aggregate reporting.
