Clinical Safety & Pharmacovigilance

Our experienced team offers fast and reliable safety management plan development and smooth execution. We ensure 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 mainly medicine and pharmacy, will maintain consistent case processing in line with international requirements while recording cases in the Safety Database with supreme at least a four-eye quality check and assessment.

We are able to provide clinical safety service in a wide range of therapeutic areas and product classes, starting from clinical safety set-up, going to continuous surveillance of the study and finalizing with study closure activities.

Biomapas clinical safety services include:

• 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.