Pharmacovigilance Database

Biomapas pharmacovigilance and clinical safety management services are supported by a fully E2B and CFR21 Part 11 compliant database. Our safety database has an integrated submission management tool for direct submissions, complex search functionality and simplified signal detection. It enables E2B-compliant XML file import and export, recording of Individual Case Safety Reports (ICSRs) and the generation of:

CIOMS I format reports;
MedWatch format reports;
Line-listings;
Summary tabulations.

In addition, Biomapas team has experience and is ready to support work in any other customer database too (e.g. ARGUS, ARISg, LSMV)

Big Enough To Cover All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

Affiliate-Based Outsourcing

CSV For Pharmacovigilance Systems

Early Phase Oncology

Functional Service Provision

M&A Support

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Big Enough To Cover All Your Needs.
Small Enough To Care.

Discover how Biomapas provides all the support to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Reliable support for every phase of your clinical trial, from recruitment to results.

Pharmacovigilance

Flexible safety monitoring to keep your products compliant and trusted.

Regulatory Affairs

Confidently navigate regulatory challenges with expert support.

Medical Information

Clear, accurate medical information 24/7, tailored for global audiences.

Quality Assurance

Export auditors help identify gaps and close them with actionable solutions.

Careers

Academy

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