Pharmacovigilance in Clinical Trials 🧪💊

Pharmacovigilance plays a critical role throughout the life cycle of a medicinal product, and clinical trials are no exception. From first-in-human studies to the end of clinical development, participant safety remains the top priority. 🛡️ 

🔍 What is pharmacovigilance in clinical trials? 

In clinical trials, pharmacovigilance focuses on detecting, assessing, understanding, and preventing adverse events or any other safety issues related to investigational medicinal products. 

This includes the collection and analysis of: – Adverse Events (AEs) – Serious Adverse Events (SAEs) – Suspected Unexpected Serious Adverse Reactions (SUSARs) 

🎯 The main goal is to ensure participant safety while maintaining full regulatory compliance. 

👥 Who is responsible? 

The trial sponsor holds primary responsibility for pharmacovigilance and may rely on specialized partners such as CROs or pharmacovigilance service providers. 

Investigators play a key role by: – Identifying adverse events – Reporting them within required timelines ⏱️ 

📋 Key regulatory requirements 

Pharmacovigilance in clinical trials is governed by strict regulations (ICH-GCP, EU Regulation 536/2014, FDA, etc.). Key obligations include: 

• Establishing an appropriate pharmacovigilance system 

• Continuous benefit-risk assessment ⚖️ 

• Timely reporting of SUSARs to authorities and ethics committees 
• Preparation and maintenance of safety reports (DSUR) 

🤝 The value of expert support 

Working with a pharmacovigilance service provider helps to: – Secure safety case management – Ensure global regulatory compliance 🌍 – Allow clinical teams to focus on their core activities 

At Pharmya, we support sponsors at every stage with tailored, compliant pharmacovigilance solutions. 

✨ Pharmacovigilance is not just a regulatory requirement — it is an ethical commitment to patients.