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.