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’ safety experts help to  set up, execute safety monitoring and minimise and appropriately manage risks to ensure patient safety during clinical trials via:  

• Coordinating safety monitoring activities 
• Review and timely reporting of safety events 
• Coordination with project teams
• Communication with the sponsor, investigator site staff, and study partners 

Our Clinical Safety Monitors take responsibility for coordinating the safety aspects of your Clinical Trials and ensuring high-quality safety reporting, documentation, and expedited reporting following international regulations and ensuring your in-house standards.  They seamlessly extend your clinical team and act as a single point of contact for internal and external stakeholders. 

Biomapas’ experts provide end-to end clinical safety service from clinical safety set-up to continuous surveillance and study close-out activities in a wide range of therapeutic areas and product classes.  They begin with a reliable safety management plan development and continue with the smooth execution of safety tasks during the study or program conduct.  

Our expert team members, who hold degrees mainly in medicine and pharmacy, maintain consistent case processing in line with international requirements, including but not limited to EMA, FDA, MHRA, other while recording cases in Biomapas or your Safety Database with at least four-eye quality checks and assessments. 

Biomapas safety team ensures Serious AE (SAE)/pregnancy reports processing: 

• Case receipt and Recording in Safety Database; 
• Safety query management and follow-up with the site; 
• MedDRA coding; 
• Case Narrative writing;
• Medical review of the case and reportability assessment; 
• SUSARs and listings reporting to regulators, ethics, investigators; 
• DSUR preparation and submission; 
• Aggregate reporting. 

Biomapas can support the Sponsor with a safety database set up for the study or program. With our safety database, we can provide: 

• Efficient safety database set-up, including individual tenant environment set-up and specific case attributes;
• Access for Sponsor;
• Possibility to generate listings and reports per study or per IMP;
• Data migration services.