Pharmacovigilance 

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Safety doesn’t happen by chance. It happens by vigilance.

Biomapas team 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 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.

Clinical Safety

Biomapas team 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.

Medical Monitoring

Biomapas Medical Monitoring team consists of highly experienced licensed medics who have gathered a 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 the following services:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts support;
  • Assistance for PM in development therapeutic area, investigational product and protocol training;
  • 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.

PV System & 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 the development of Risk Management Plans (RMPs) and risk minimization measures handling;
  • Development and submission of Periodic Safety Update Reports (PSURs);
  • Pharmacovigilance audit and inspection handling.

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

Medical Monitoring

Biomapas Medical Monitoring team consists of highly experienced licensed medics who have gathered a 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 the following services:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts support;
  • Assistance for PM in development therapeutic area, investigational product and protocol training;
  • 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.

Medical Monitoring

Biomapas Medical Monitoring team consists of highly experienced licensed medics who have gathered a 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 the following services:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts support;
  • Assistance for PM in development therapeutic area, investigational product and protocol training;
  • 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.

PV System & 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 the development of Risk Management Plans (RMPs) and risk minimization measures handling;
  • Development and submission of Periodic Safety Update Reports (PSURs);
  • Pharmacovigilance audit and inspection handling.

PV Professionals

%

Medical Doctors

Countries covered

Strength

Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.

Strength

Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.

Strength

Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.

Webinar

Setting up your PV system in a single day.

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A partner that is dedicated to you and understands the challenges you face. 

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Eglė Pavyde

Eglė Pavyde

Business Development Director

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