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Pharmacovigilance Services for Clinical Trials

Ensuring Patient Safety and Regulatory Compliance

At ClinOpsHub, we provide Pharmacovigilance (PV) services to ensure the highest safety standards for investigational medicinal products (IMPs) used in clinical trials. Our expertise guarantees compliance with Good Pharmacovigilance Practices (GVP) and regulatory requirements, safeguarding both trial participants and study data integrity.

Our Pharmacovigilance Services

We support Sponsors, Contract Research Organizations (CROs), and healthcare professionals in meeting pharmacovigilance requirements throughout all phases of clinical research.

1. Case Processing & Safety Reporting

  • Collection, assessment, and processing of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  • Expedited reporting to regulatory authorities 

  • Preparation of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports

  • Ongoing communication with investigators, Sponsors, and all stakeholders involved.

Why Choose Us?

  • Regulatory Expertise: Compliance with regulatory authorities, and ICH-GCP guidelines

  • 24/7 Safety Availability: Immediate managing of critical safety events

  • Customized Solutions: Tailored PV strategies to meet study-specific requirements and needs

Contact Us

For more information on our pharmacovigilance services, get in touch with our experts.

Partners

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MedBioteQ
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