Our Services
Clinical Trial Pharmacovigilance Services
End-to-end safety services for clinical trials and marketed products. ICSR processing, aggregate reporting and signal management.
Pharmacovigilance
What We Deliver
TCR Solutions delivers ICSR case processing and expedited reporting, SUSAR management and regulator notifications, DSURs, PSURs and PBRERs, and signal detection and benefit-risk evaluation.
We also provide safety database setup and hosting (Argus, ARISg) and Qualified Person for Pharmacovigilance (QPPV) services — scalable from first-in-human studies through to post-marketing commitments, all to MHRA, EMA and FDA standards.
The Value
Why It Matters
Patient safety is non-negotiable and PV must be airtight.
Our pharmacovigilance services help you avoid GVP and 21 CFR 312 compliance findings, provide scalable safety infrastructure from first-in-human to post-marketing, and ensure every safety signal is detected, evaluated and reported on time.
FAQs
Frequently Asked Questions
Do you provide a QPPV? Yes — TCR provides UK and EU QPPV and deputy QPPV services.
Which safety databases do you support? We work with Oracle Argus, ARISg and other validated safety platforms.