Pharmacovigilance Services

Our end-to-end services span clinical R&D, review & registration and post-marketing phases. Our established PV framework supports clinical and commercial products.

Clinical Research and Development

Regulatory Review and Registration

Post-marketing

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Benefit-Risk Management

Well-rounded safety profiling of investigational and marketed products

Case Processing

Collection, data entry, medical assessment & expedited reporting

Safety Systems and Reporting

Global ICSR and aggregate report submission expertise

GVP Audits/Inspection Readiness

Experience with FDA, Health Canada, BfArM, MHRA & SUKL inspections

QPPV and PSMF

Fully compliant PV systems ensured by our global network

Local Contact Person Responsible for Pharmacovigilance

Our vast PV network at your service

Medical Information

Monitor product use & identify safety concerns promptly

Safety and Medical Writing

Prowess in global medical safety and reporting

Literature Surveillance

Non-stop screening for early insights into safety

Signal Management

Detection, validation and evaluation

Pharmacoepidemiology

Improve patient safety through observational research

Medical Monitoring

Looking for safety trends from an early stage

Safety Management Plan

Determined by clinical study phase, indication and subjects

Clinical Trial Safety Committee Management

Co-ordination of DMC, DSMB and Adjudication Committees

Project Management

An integral part of your safety team

Benefit-Risk Management

Well-rounded safety profiling of investigational and marketed products

Case Processing

Collection, data entry, medical assessment & expedited reporting

Safety Systems and Reporting

Global ICSR and aggregate report submission expertise

GVP Audits/Inspection Readiness

Experience with FDA, Health Canada, BfArM, MHRA & SUKL inspections

QPPV and PSMF

Fully compliant PV systems ensured by our global network

Local Contact Person Responsible for Pharmacovigilance

Our vast PV network at your service

Medical Information

Monitor product use & identify safety concerns promptly

Safety and Medical Writing

Prowess in global medical safety and reporting

Literature Surveillance

Non-stop screening for early insights into safety

Signal Management

Detection, validation and evaluation

Pharmacoepidemiology

Improve patient safety through observational research

Medical Monitoring

Looking for safety trends from an early stage

Safety Management Plan

Determined by clinical study phase, indication and subjects

Clinical Trial Safety Committee Management

Co-ordination of DMC, DSMB and Adjudication Committees

Project Management

An integral part of your safety team

Benefit-Risk Management

Well-rounded safety profiling of investigational and marketed products

Case Processing

Collection, data entry, medical assessment & expedited reporting

Safety Systems and Reporting

Global ICSR and aggregate report submission expertise

GVP Audits/Inspection Readiness

Experience with FDA, Health Canada, BfArM, MHRA & SUKL inspections

QPPV and PSMF

Fully compliant PV systems ensured by our global network

Local Contact Person Responsible for Pharmacovigilance

Our vast PV network at your service

Medical Information

Monitor product use & identify safety concerns promptly

Safety and Medical Writing

Prowess in global medical safety and reporting

Literature Surveillance

Non-stop screening for early insights into safety

Signal Management

Detection, validation and evaluation

Pharmacoepidemiology

Improve patient safety through observational research

Medical Monitoring

Looking for safety trends from an early stage

Safety Management Plan

Determined by clinical study phase, indication and subjects

Clinical Trial Safety Committee Management

Co-ordination of DMC, DSMB and Adjudication Committees

Project Managment

An integral part of your safety team

Our Company

End-to-end services for high-quality safety and pharmacovigilance operations

Technology-driven solutions integrated into the pharmacovigilance landscape

Product expertise which enables efficiencies in PV operations

Insights Hub

Trending Topics, Case Studies, Articles

Latest Case Studies

Webinars

Latest Webinar

News and Events

NEWS – Pharmacovigilance Knowledge-Sharing Webinar open for registration

EVENT – DIA 2023 Global Annual Meeting | Boston, MA

Pharmacovigilance Services

Industry-leading pharmacovigilance and clinical safety services

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

GVP Audits/Inspection Readiness

QPPV and PSMF

Local Contact Person Responsible for Pharmacovigilance

Medical Information

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmaco­epidemiology

Medical Monitoring

Safety Management Plan

Clinical Trial Safety Committee Management

Project Management

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

GVP Audits/Inspection Readiness

QPPV and PSMF

Local Contact Person Responsible for Pharmacovigilance

Medical Information

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmaco­epidemiology

Medical Monitoring

Safety Management Plan

Clinical Trial Safety Committee Management

Project Management

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

GVP Audits/Inspection Readiness

QPPV and PSMF

Local Contact Person Responsible for Pharmacovigilance

Medical Information

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmaco­epidemiology

Medical Monitoring

Safety Management Plan

Clinical Trial Safety Committee Management

Project Managment

Discover how we can help you

Pharmacoepidemiology

Pharmacoepidemiology

Pharmacoepidemiology