Introducing ClinOpsHub’s Pharmacovigilance Department: Ensuring Safety in Clinical Trials

At ClinOpsHub, we are dedicated to safeguarding the highest standards of patient safety and regulatory compliance in clinical research. With the launch of our Pharmacovigilance Department, we now offer specialized Pharmacovigilance (PV) services to support Sponsors, CROs, and healthcare professionals throughout every phase of clinical trials. We ensure compliance with Good Pharmacovigilance Practices (GVP) and global regulatory requirements, safeguarding both trial participants and the integrity of study data.

Our Pharmacovigilance Services

1. Case Processing & Safety Reporting

Pharmacovigilance begins with the collection, assessment, and processing of Adverse Events (AEs) and Serious Adverse Events (SAEs) of a clinical trial. Our team ensures timely and accurate:

Expedited reporting to regulatory authorities (e.g. EudraVigilance)
Preparation and submission of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports
Ongoing communication with investigators and Sponsors to ensure real-time safety monitoring.

2. 24/7 Medical Monitoring & Benefit-Risk Assessment

Ensuring the safety of clinical trial participants requires continuous monitoring. Our 24/7 medical monitoring team provides:

Immediate response to safety concerns
Expert evaluation of causality, severity, and clinical relevance of reported AEs
Integration of safety data into periodic clinical trial reports, enhancing transparency and regulatory compliance.

3. Regulatory Compliance & Safety Documentation

Navigating the complex regulatory landscape of pharmacovigilance is crucial. Our services include:

Development Safety Update Reports (DSURs) preparation and submission
Investigator Brochure (IB) updates to reflect the latest safety data
Support with Clinical Trial Application (CTA) submissions to regulatory bodies.

4. EU Responsible Person for Pharmacovigilance

For trials conducted in the European Union, compliance with EU pharmacovigilance requirements is essential. ClinOpsHub provides an EU Responsible Person for Pharmacovigilance (RP) to: