Clinical Safety & Pharmacovigilance
Biomapas’ experts 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.
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 mostly medicine and pharmacy will maintain consistent case processing in line with all EMA requirements while recording cases in Safety Database with supreme at least four-eye quality check and assessment.
Biomapas clinical safety services include:
- 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.