---
title: "Clinical Pharmacovigilance Service — Clinical Solutions | QbD Group"
description: "Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects. At QbD Group, we offer full pharmacovigilance services for the sa"
url: https://qbdgroup.com/en/services/clinical-solutions/clinical-pharmacovigilance-service
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Clinical Pharmacovigilance Service — Clinical Solutions | QbD Group\", https://qbdgroup.com/en/services/clinical-solutions/clinical-pharmacovigilance-service"
---

# Clinical Pharmacovigilance Service

Comprehensive safety oversight for your clinical trials

Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects. At QbD Group, we offer full pharmacovigilance services for the safety management of your clinical trials.

## What is clinical pharmacovigilance?

Pharmacovigilance is the science of **detecting, assessing, and preventing adverse effects** or drug-related problems during clinical trials.

High-quality safety data is essential to determine safety profiles, identify dosage levels, and balance risk/benefit ratios. To meet global and local regulatory requirements (e.g., Regulation EU No 536/2014, ICH-E6), clinical trials require precise, traceable, and compliant safety management.

## Why is clinical pharmacovigilance important?

Protecting participants and ensuring compliance are top priorities in clinical research.

### Participant safety

Timely detection and management of adverse reactions ensure participant safety.

### Data integrity

Compliance with ALCOA(+) principles ensures data quality for smooth trial progression.

### Regulatory compliance

Strict safety monitoring avoids delays and regulatory issues.

### Risk management

Early detection allows proactive strategies to minimize harm.

### Ethical considerations

Safeguarding participant well-being is a core ethical obligation.

## How can we help?

We ensure clinical trials are conducted with the highest standards of safety, prioritizing patient care.

### Protocol review

Ensuring trial protocols align with GCP guidelines.

### EudraVigilance registration

Assisting with setup and maintenance of the EudraVigilance database.

### SDEA

Establishing Safety Data Exchange Agreements.

### Safety database management

Setting up and managing E2B-compliant safety databases.

### Training

Tailored pharmacovigilance training for sponsor and site staff.

### Safety case management

Evaluation, management, and expedited reporting of safety cases.

### DSURs

Creation of Development Safety Update Reports.

Why QbD Group

## Your trusted partner

Do you lack an in-house safety team, or just need expert guidance? QbD Group is here to help.

Expertise you can trust: highly skilled professionals ensuring utmost quality and safety.

24/7 accessibility: prompt assistance and support whenever required.

## Plan your clinical pathway

From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.

Contact us

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Source: https://qbdgroup.com/en/services/clinical-solutions/clinical-pharmacovigilance-service — © QbD Group. Quote freely with attribution and a link back.