Clinical Trial Pharmacovigilance Services
Pharmacovigilance Services for Phase I, Phase II and Phase III Clinical Trials
TCR-Solutions provides clinical trial pharmacovigilance services for Phase I, Phase II, and Phase III clinical trials. As a UK CRO with global reach, we support sponsors with pharmacovigilance systems and processes designed to maintain patient safety, support regulatory compliance and enable consistent safety oversight throughout clinical development.
Our pharmacovigilance model is designed to ensure consistent safety oversight across all phases of development, from first-in-human studies through to large-scale Phase III programmes.
Our Clinical Trial Pharmacovigilance Services include:
• ICSR processing and expedited reporting
• SUSAR detection, management, and regulatory submission
• Development Safety Update Reports (DSURs)
• Periodic safety reporting, including PSURs and PBRERs
• Signal detection and benefit-risk evaluation
• Safety database setup and management (e.g. Argus, ARISg)
• Qualified Person for Pharmacovigilance (QPPV) services
We integrate closely with Medical Monitoring and Clinical Trial Regulatory Affairs Services to ensure a coordinated approach to safety oversight and regulatory compliance.
Why Pharmacovigilance Matters in Clinical Trials
Pharmacovigilance is essential to the safe and compliant delivery of Phase I, Phase II and Phase III clinical trials. It supports timely safety reporting, ongoing evaluation of emerging safety data and alignment with regulatory requirements across the study lifecycle.
Weak pharmacovigilance processes can lead to delayed reporting, inconsistent safety oversight and increased regulatory risk.
At TCR-Solutions, our clinical trial pharmacovigilance services are designed to support:
• Timely and accurate safety reporting
• Alignment with MHRA, EMA, and FDA requirements
• Effective detection and management of safety signals
• Scalable pharmacovigilance support for global clinical trials
Frequently Asked Questions
Do you support pharmacovigilance for Phase III clinical trials?
Yes. We provide clinical trial pharmacovigilance services across Phase I, Phase II and Phase III clinical trials, including large and multi-country studies.
What is included in your clinical trial pharmacovigilance services?
Our services include ICSR processing, SUSAR management, DSURs, periodic safety reporting, signal detection, safety database management and QPPV support.
Do you support global pharmacovigilance requirements?
Yes. We support pharmacovigilance activities aligned with UK, EU and global regulatory requirements, including MHRA, EMA and FDA expectations.