Pharmacovigilance

Our pharmacovigilance support ranges from full, 24/7 assistance service with global coverage, to tailored services based on client needs.

Clinical Research
Regulatory Affairs

Clinical Safety

Biomapas supports Sponsors in clinical research with the services of high-quality safety data processing, handling and reporting, including:

  • Safety management planning;
  • Adverse Events processing, including recording in Safety Database;
  • MedDRA coding;
  • Narrative writing;
  • Medical data review;
  • SUSARs handling;
  • Aggregate reporting.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

Medical Monitoring

Biomapas supports Sponsors in clinical research with Medical Monitoring services, including:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts
  • Medical Monitoring Plan development
  • 24/7 support to site personnel on medical matters
  • Medical input into adverse event handling
  • Medical data review
  • Investigator / site education

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

Pharmacovigilance System including EU-QPPV

Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System, and offers experienced EU Qualified Person for Pharmacovigilance who will be responsible for:

  • Pharmacovigilance System set-up and development/maintenance of the Pharmacovigilance System Master File (PSMF);
  • Implementation of ISO 90101:2015 Quality Management System aspects;
  • Local pharmacovigilance representation in each of the country with the wide network of Biomapas Local Safety Officers (LSOs);
  • Timely and quality full-scale processing of Individual Case Safety Reports (ICSRs);
  • ICSRs records in E2B and CFR21 compliant Safety Database;
  • EudraVigilance support, including mandatory ongoing medicinal product data reporting to XEVMPD;
  • Regular global and local literature monitoring;
  • Ongoing safety surveillance, signal detection validation, evaluation and further processing;
  • Risk management, including development of Risk Management Plans (RMPs) and risk minimization measures handling;
  • Development and submission of Periodic Safety Update Reports (PSURs);
  • Pharmacovigilance audits and inspections handling.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

EudraVigilance (including XEVMPD) Support

EudraVigilance (including XEVMPD) Support.

Pharmacovigilance Database

Biomapas pharmacovigilance and clinical safety management services are supported by a fully E2B and CFR21 Part 11 compliant database, which 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

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

Materiovigilance

Biomapas not only supports Marketing Authorisation Holders with safety surveillance of medicinal products, but also supports manufacturers and/or distributors of medical devices with safety surveillance. Our services include:

  • Pre- and post-marketing safety surveillance services for all classes of medical devices
  • Processing and handling of Incidents and Near Incidents
  • Reporting of Incidents and Near Incidents to relevant authorities
  • Preparation and submission of Periodic Summary and Trend reports
  • Handling of quality complaints

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

Medical Information

With a team of experienced multinational professionals, Biomapas offers multilingual Medical Information services, covering:

  • Prompt first-line medical enquiries management;
  • Secondary medical support to medical enquiries;
  • Medical writing for medical information needs;
  • Maintenance of medically approved standardized answers lists;
  • Access to medical experts’ support as required.

Biomapas Medical Information service flowchart provided below:

call center

For any inquiry regarding our services, please contact Biomapas Business Development team.