---
title: "临床药物警戒服务 — Clinical Solutions | QbD Group"
description: "药物警戒是识别、评估和预防不良反应的科学。QbD Group 为您的临床研究提供全面的药物警戒服务。"
url: https://qbdgroup.com/zh-cn/services/clinical-solutions/clinical-pharmacovigilance-service
type: "Page"
language: zh-cn
publisher: "QbD Group"
citation: "QbD Group, \"临床药物警戒服务 — Clinical Solutions | QbD Group\", https://qbdgroup.com/zh-cn/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.

为什么选择QbD Group

## 您值得信赖的合作伙伴

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.

## 规划您的临床路径

从差距评估到完整 CRO 交付,我们的临床专家随时为您的 MedTech 旅程提供支持。

联系我们

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