Pharmacovigilance/Market Surveillance
Safety & Pharmacovigilance
At Premium Medical Complex Clinical Trial Unit, patient safety is our highest priority. Our dedicated pharmacovigilance framework ensures compliance with ICH-GCP, DRAP, and global regulatory requirements through the following responsibilities:
- Adverse Event (AE) & Serious Adverse Event (SAE) Management
Timely detection, documentation, and reporting of AEs/SAEs in accordance with study protocols and regulatory timelines. - Causality & Severity Assessment
Medical evaluation of adverse events by qualified investigators to ensure accurate safety reporting. - Regulatory & Sponsor Reporting
Submission of safety reports to Sponsors, CROs, and regulatory authorities as per applicable guidelines. - Safety Data Integrity
Maintaining complete, accurate, and confidential pharmacovigilance records in line with Good Clinical Practice. - Training & Awareness
Continuous training of investigators, study staff, and safety teams to strengthen pharmacovigilance practices. - Patient Protection
Immediate risk mitigation actions to safeguard trial participants, including medical management and follow-up. - Collaboration with Sponsors/CROs
Active coordination with Sponsors and CROs for expedited safety communication and compliance.
Pharmacovigilance in clinical trials refers
Pharmacovigilance in clinical trials refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems during the clinical development phase of a pharmaceutical product. It plays a critical role in ensuring patient safety and maintaining the integrity of the clinical trial data.
Also known as PV clinical trial role, pharmacovigilance in this context focuses on monitoring investigational drugs to identify potential risks early and ensure compliance with regulatory requirements.
According to the International Council for Harmonisation (ICH) E2A and E6 guidelines, sponsors are required to have systems in place for monitoring and managing safety data during clinical trials. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate timely reporting of serious and unexpected adverse events.
Pharmacovigilance in clinical trials is applied across all phases of drug development:
Focuses on identifying dose-limiting toxicities and initial safety profile.
Expands safety monitoring to a larger patient population while assessing efficacy.
Continues safety surveillance in diverse populations and longer durations.
Though outside clinical trials, PV continues to monitor long-term safety.
Roles and Responsibilities
- Sponsor: Responsible for establishing a pharmacovigilance system and ensuring timely reporting.
- Investigator: Reports AEs to the sponsor and ethics committees.
- Clinical Research Organization (CRO): Often manages PV activities on behalf of the sponsor.
- Regulatory Authorities: Review safety data and enforce compliance.
Challenges in PV During Clinical Trials
- Under-reporting of adverse events by investigators
- Difficulty in establishing causality
- Data integration from multiple sites and systems
- Ensuring global regulatory compliance
Why is Pharmacovigilance Important?
Pharmacovigilance plays a critical role in clinical trials by generating reliable data on a drug’s risks and benefits. This information helps determine whether the benefits outweigh the risks, guiding manufacturers in seeking regulatory approval to bring the drug to market.
Safety profile analysis during Phase I, II, and III clinical trials provides valuable insights for further research and development (R&D) or for submission to regulatory bodies when seeking entry into new markets.
Following Phase III trials and marketing authorization, pharmaceutical companies may conduct Phase IV (post-marketing) studies to monitor the drug’s safety on a larger scale and in real-world conditions—a process known as post-marketing surveillance.
Why is Post-Marketing Surveillance Important?
Post-Marketing Surveillance (PMS) ensures the continued safety and effectiveness of drugs after they are approved and in widespread use. It helps detect rare or long-term side effects, monitors product quality, and safeguards public health by enabling timely regulatory action when needed.
How Post-Marketing Surveillance Helps
PMS provides real-world data that may not emerge during controlled clinical trials. It identifies adverse drug reactions, tracks usage patterns, and uncovers potential safety concerns, allowing healthcare professionals and regulators to make informed decisions about risk management.
How CTU-PMC Can Assist You in Conducting PMS
CTU-PMC offers comprehensive support for Post-Marketing Surveillance, including study design, data collection, analysis, and regulatory reporting. Our expertise ensures compliance with international standards while delivering accurate and actionable safety insights.
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