Pharmacovigilance

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

Clinical Safety

Biomapas team experts are able to provide clinical safety service in 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 holds 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 includes:

  • 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.

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

contact-us

Medical Monitoring

Biomapas Medical Monitoring team consist of highly experienced licensed medics who have gathered significant amount of experience in various therapeutic areas throughout the years in Phase I-IV studies.

According to Sponsor needs Biomapas Medical Monitors are able to provide following services:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts support;
  • Assistance for PM in development therapeutic area, investigational product and protocol trainings;
  • Assistance for PM in identifying the key risks to data critical to the primary objective and provision of medical input into risk mitigation strategies;
  • Medical Monitoring Plan development;
  • 24/7 coverage medical monitoring;
  • Medical Monitor oversight and support to study team, investigators and sites;
  • Assurance of safety and quality by assisting in protocol interpretation, laboratory and ECG surveillance;
  • Medical input into adverse event handling, including review of cumulative SAE listings and any other emergent safety information;
  • Review of the clinical data and critical parameters of the study;
  • Provision of input in corrective actions plans;
  • Medical coding of AEs and medications;
  • Investigator / site education (Preparation of training material for Investigators, attendance at Investigators Meeting);
  • Provision of medical input in regulatory submissions, if required.

 

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

contact-us

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.

contact-us

EudraVigilance (including XEVMPD) Support

EudraVigilance (including XEVMPD) Support.

 

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

contact-us

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.

contact-us

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.

contact-us

Local Pharmacovigilance Representation

  • Appointment of Lead LSO and Deputy LSO for each country and their nomination to the local Competent Authority;
  • 24/7 availability, where required;
  • Weekly monitoring of locally published scientific and medical literature;
  • Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable;
  • National regulatory intelligence;
  • Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling;
  • Delivery of pharmacovigilance trainings to local Marketing Authorisation Holders personnel.

 

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

contact-us

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.

contact-us

Clinical Safety

Biomapas team experts are able to provide clinical safety service in 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 holds 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 includes:

  • 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.

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

contact-us

Medical Monitoring

Biomapas Medical Monitoring team consist of highly experienced licensed medics who have gathered significant amount of experience in various therapeutic areas throughout the years in Phase I-IV studies.

According to Sponsor needs Biomapas Medical Monitors are able to provide following services:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts support;
  • Assistance for PM in development therapeutic area, investigational product and protocol trainings;
  • Assistance for PM in identifying the key risks to data critical to the primary objective and provision of medical input into risk mitigation strategies;
  • Medical Monitoring Plan development;
  • 24/7 coverage medical monitoring;
  • Medical Monitor oversight and support to study team, investigators and sites;
  • Assurance of safety and quality by assisting in protocol interpretation, laboratory and ECG surveillance;
  • Medical input into adverse event handling, including review of cumulative SAE listings and any other emergent safety information;
  • Review of the clinical data and critical parameters of the study;
  • Provision of input in corrective actions plans;
  • Medical coding of AEs and medications;
  • Investigator / site education (Preparation of training material for Investigators, attendance at Investigators Meeting);
  • Provision of medical input in regulatory submissions, if required.

 

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

contact-us

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.

contact-us

EudraVigilance (including XEVMPD) Support

EudraVigilance (including XEVMPD) Support.

 

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

contact-us

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.

contact-us

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.

contact-us

Local Pharmacovigilance Representation

  • Appointment of Lead LSO and Deputy LSO for each country and their nomination to the local Competent Authority;
  • 24/7 availability, where required;
  • Weekly monitoring of locally published scientific and medical literature;
  • Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable;
  • National regulatory intelligence;
  • Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling;
  • Delivery of pharmacovigilance trainings to local Marketing Authorisation Holders personnel.

 

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

contact-us

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.

contact-us