Clinical Pharmacovigilance Service

Are you exploring options to outsource pharmacovigilance safety management for your upcoming clinical trial involving medicinal products for human use? Ensuring comprehensive safety oversight is not just essential—it’s critical to the success of your trial.

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 an investigational drug’s safety profile.
Identify appropriate dosage levels.
Balance the risk/benefit ratio.
Detect potential risks and interactions.

To meet global and local regulatory requirements (e.g., Regulation EU No 536/2014 or Directive 2001/20/EC), guidelines (e.g., ICH-E6, ICH-E2B, ICH-E2F etc.), clinical trials require precise, traceable, and compliant safety management.

Why is it important?

Participant safety

Protecting human participants is a top priority. Timely detection and management of adverse reactions or side effects ensure participant safety.

Data integrity

Compliance with ALCOA(+) principles ensures data quality, enabling smooth trial progression and eventual marketing authorization.

Regulatory compliance

Strict safety monitoring compliance avoids delays and regulatory issues, keeping your trial on track.

Risk management

Early detection and assessment of potential risks allows proactive strategies to minimize harm and support trial success.

Ethical considerations

Safeguarding participant well-being is a core ethical obligation in clinical research, demonstrating your commitment to responsible trial conduct.

How can we help?

We ensure clinical trials are conducted with the highest standards of safety, prioritizing patient care and well-being every step of the way.

Our pharmacovigilance (PV) services include:

Protocol review: ensuring trial protocols align with Good Clinical Practice (GCP) guidelines.
EudraVigilance registration: assisting with setup and maintenance of the EudraVigilance database to support the client with safety reporting for studies which are conducted in the European Union (EU).
Safety Data Exchange Agreement (SDEA): establishing clear roles, responsibilities, and workflows for all parties involved.
Safety database management: setting up and managing E2B-compliant safety databases, including reconciliations.
Training: providing tailored pharmacovigilance training for sponsor and site staff.
Safety case evaluation, management, and expedited reporting.
Development Safety Update Reports (DSURs)

Get in touch

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Why QbD Group?

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

Expertise you can trust
With a team of highly skilled professionals boasting extensive experience, we ensure the utmost quality and safety for our clients.
24/7 accessibility
We ensure that our clients receive prompt assistance and support whenever they require it.

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Discover all

Clinical Pharmacovigilance Service

What is clinical pharmacovigilance?

Why is clinical pharmacovigilance important?

Participant safety

Participant safety

Data integrity

Data integrity

Regulatory compliance

Regulatory compliance

Risk management

Ethical considerations

How can we help?

Why QbD Group?

Get in touch

Resources

Fast-Tracked Site Qualification for Clinical Trial Submission

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

Clinical investigations under MDR: key insights and practical experiences

The pathway from idea to patient under MDR

CE Mark Renewal for bioXtra Products: A Success Story

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter