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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’s 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 the 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

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

Registration

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

Safety

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)

Training

SAE processing and global regulatory requirement preparation & training

PV and MM Team

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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

Our team is composed of highly qualified staff, including MDs, PharmD PV officers, and medical referents. We are committed to delivering quality-driven results, ensuring that your development is carried out safely amidst the complex regulatory environment of FDA and EMA.

Related Information

Phase I Healthy Volunteers Specialized Phase I Trials Oncology Trial Management Patient Trial Management Clinical Monitoring Pharmacovigilance & Medical Monitoring Pharmaceutical Affairs Regulatory Affairs