Pharmacovigilance & Medical Monitoring

As part of our solutions as a Full-service-cro, Biotrial provides comprehensive pharmacovigilance (PV) and medical monitoring (MM) services for clinical trials. Our team of experts has the global capabilities to ensure the safety and well-being of subjects throughout the entire study process, from study design to final close-out.

Our PV services include:

  • Identification, assessment, and management of adverse events (AEs)
  • Review of clinical trial data for safety signals
  • Risk management planning
  • Regulatory compliance

Our MM services include:

  • Medical assessment of subjects
  • Monitoring of subject safety
  • Provision of medical support to investigators
  • Training of investigators on safety procedures

Pharmacovigilance Services

Biotrial PV team can offer full service including:

  • Safety management plan redaction
  • Safety database set-up and maintenance
  • SAE management
  • CIOMS (EU)/MedWatch for 3500a (US) Editing
  • SUSAR reporting on Eudravigilance platform/transfer to Medwatch point of contact
  • Reconciliation with EDC database throughout the study

Development Safety Update Report (DSUR) writing: A clinical trial safety report is submitted annually to health authorities among the ICH regions. Our experienced PV team can manage DSUR development for our clients.

Medical Monitoring Service

Biotrial Clinical Pv Medical Monitoring Service

Our team of medical monitors can provide a wide range of services, including:

  • Review and feedback on study documents: We can review and provide feedback on study protocols, amendments, deviations, informed consent forms (ICFs), individual patient profiles (IPPS), study administration plans (SAPs), trial master files (TMFs), clinical study reports (CSRs), and development safety update reports (DSURs).
  • 24/7 patient safety assessment: Available 24/7 to assess patient safety and other clinical issues.
  • Periodic medical data review: We identify and manage safety risks.
  • Primary liaison with sites: All members of the study team for all medical related issues and questions for our studies.

Added values

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Biotrial can register as a Third Service Provider with applicable authorities, such as the FDA and EMA, to help sponsors to meet their regulatory obligations and ensure that their clinical trials are conducted in compliance with applicable regulations.



Safety plan redaction and distribution as well as database set-up and maintenance (SafetyEasy®)


Experience with eudravigilance

The PV team has experience with the reporting and compound data registration in XEVMPD (IMP declaration)



Preparation & training to SAE processing from PV team to CRA as well as regulatory requirement of many different countries

Biotrial Clinical Pv Medical Monitoring Service

PV and MM Team

Composed of highly qualified staff, including MDs, PharmDs, PV officers, and medical referents, our team is committed to providing our clients with the highest quality PV and MM services in a complex regulatory environment.

Our experts are trained in a wide range of PV and MM services, including:

  • Safety management plan development and implementation
  • Adverse event (AE) monitoring and reporting
  • Risk management
  • Medical monitoring
  • Data analysis and interpretation
  • Regulatory support

The team is composed of highly qualified staff such as MD, PharmD PV officers and medical referents. All of our deliverables are quality driven, making sure that your development is made safely in an even more complex regulatory environment (FDA, EMA).

Participate in a clinical trial

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