Biomapas
Biomapas is a pan-European pharma services provider rooted in the Baltics, offering worldwide Pharmacovigilance, Medical Information, Clinical Development, and Regulatory Affairs services. They support clinical trials and drug development processes with tailored solutions, acting as a seamless extension of client teams with global reach and local expertise. The company emphasizes the strategic importance of including Eastern Europe in clinical trial planning due to its large patient populations, high recruitment rates, proven quality standards, experienced investigators, favorable regulatory environment, and cost advantages. Biomapas provides comprehensive support across clinical research, regulatory affairs, pharmacovigilance, medical information, and other specialized services to accelerate drug development and ensure regulatory compliance. They advocate for the benefits of regional site networks, functional service provision models, and adaptive trial designs to optimize clinical trial success. Biomapas also actively participates in industry organizations like SwedenBIO and AICROS, and offers guidance on navigating complex regulatory landscapes, including the EU Clinical Trial Regulation and emerging FDA guidance on diversity. The company values privacy and employs cookies to enhance user experience.
Industries
Nr. of Employees
medium (51-250)
Services
Clinical strategy and protocol design; operational execution from early‑phase through Phase III; feasibility and site selection (including Eastern Europe); patient recruitment and rescue site activation; site management, data management and authority interaction support.
Feasibility assessments, selection and operational management of regional site networks to improve access to treatment‑naïve populations, accelerate enrollment and manage competitive trial density.
End-to-end PV services including system set-up, qualified person provision, case processing (ICSRs), safety database management, aggregate reporting, RMP/PSMF development, literature screening and PV audits.
Regulatory strategy, gap analysis, dossier preparation and submissions across EU, EAEU and national pathways; lifecycle management, authority interaction support and management of local submission requirements (translations, notarization, investigational product import handling).
Continuous medical information contact centre, content creation and localisation, translation of response documents, analytics from MI activities and integration with PV and RA workflows.
Clinical strategy and protocol design; operational execution from early‑phase through Phase III; feasibility and site selection (including Eastern Europe); patient recruitment and rescue site activation; site management, data management and authority interaction support.
Feasibility assessments, selection and operational management of regional site networks to improve access to treatment‑naïve populations, accelerate enrollment and manage competitive trial density.
End-to-end PV services including system set-up, qualified person provision, case processing (ICSRs), safety database management, aggregate reporting, RMP/PSMF development, literature screening and PV audits.
Regulatory strategy, gap analysis, dossier preparation and submissions across EU, EAEU and national pathways; lifecycle management, authority interaction support and management of local submission requirements (translations, notarization, investigational product import handling).
Continuous medical information contact centre, content creation and localisation, translation of response documents, analytics from MI activities and integration with PV and RA workflows.
Expertise Areas
- Clinical trial management and execution
- Site selection and feasibility for Eastern Europe and CIS markets
- Patient recruitment and rescue site strategies
- Pharmacovigilance and safety surveillance operations
Key Technologies
- Safety database software for adverse event management
- Natural language processing (NLP) for social and online source screening
- Site feasibility assessment and regional site network management
- Patient recruitment analytics and recruitment strategy tools
News & Updates
We are pleased to announce the appointment of David Passov as our new CEO, effective 21st February 2025.
Balancing agility, reach, and patient focus in clinical trials requires the right partners. Hear from a panel of experts across CRO and global and emerging site networks for real-world insights.
We are pleased to announce the appointment of David Passov as our new CEO, effective 21st February 2025.
Balancing agility, reach, and patient focus in clinical trials requires the right partners. Hear from a panel of experts across CRO and global and emerging site networks for real-world insights.