Pharmacovigilance plays a critical role in safeguarding patient safety and supporting regulatory compliance throughout the lifecycle of pharmaceutical products and medical devices. Effective PV management requires continuous collection, assessment, monitoring, and reporting of safety information from clinical development through post-marketing surveillance.
With extensive experience in Phase I–IV clinical studies, bioequivalence studies, investigator-initiated trials, and post-marketing projects, Protheragen delivers flexible and scalable pharmacovigilance solutions tailored to sponsors' regulatory and operational needs.
Our multidisciplinary safety team supports projects across multiple therapeutic areas, including oncology, respiratory diseases, endocrinology, immunology, ophthalmology, neurology, and infectious diseases.
Protheragen provides comprehensive pharmacovigilance solutions covering clinical development, post-marketing surveillance, safety reporting, signal management, and regulatory compliance support throughout the product lifecycle.
| Service Area | Description |
|---|---|
| Intensive Drug Monitoring | Continuous safety monitoring and adverse event surveillance during clinical development and post-marketing stages. |
| Drug Safety Information Management | Collection, maintenance, reconciliation, and quality control of drug safety data. |
| Individual Case Safety Report (ICSR) | End-to-end adverse event case processing, coding, narrative writing, and expedited reporting. |
| Medical Review | Scientific assessment of safety cases, causality evaluation, and benefit-risk analysis. |
| Literature Searching & Processing | Global literature surveillance and literature-based safety case management. |
| Signal Detection & Management | Identification, evaluation, and tracking of emerging safety signals and risks. |
| PSUR Preparation | Periodic safety update report preparation and cumulative safety evaluation. |
| DSUR Preparation | Annual development safety reporting for investigational products. |
| Risk Management Plan (RMP) Development | Development of risk minimization strategies and pharmacovigilance activities. |
| Safety Summary Analysis & Reporting | Integrated safety data analysis and aggregate safety reporting support. |
| PV System Construction & Maintenance | Establishment and optimization of compliant pharmacovigilance systems and SOPs. |
| Pharmacovigilance Consultancy | Regulatory guidance, compliance assessment, and strategic PV consulting. |
| Pharmacovigilance Database Support | Safety database setup, validation, maintenance, and workflow management. |
Our pharmacovigilance team has extensive knowledge of global regulatory requirements across China, the United States, Europe, Japan, Australia, New Zealand, and other international markets, ensuring compliant and efficient safety management throughout the product lifecycle.
Protheragen is supported by highly experienced pharmacovigilance professionals with multilingual capabilities in English, Japanese, Korean, and Chinese, enabling effective communication and support for global clinical and post-marketing projects.
We have established comprehensive pharmacovigilance SOPs, continuous training programs, and quality management procedures aligned with international standards, while continuously tracking updates in global PV regulations and industry practices.
Integrated solutions for domestic and international registration pathways.
Our team has supported numerous Phase I–IV clinical trials, BE studies, investigator-initiated trials, medical device studies, and post-marketing projects across multiple therapeutic areas, including oncology, respiratory diseases, immunology, ophthalmology, and endocrinology.
1. What is pharmacovigilance?
Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems to ensure patient safety throughout the product lifecycle.
2. Why is pharmacovigilance important in clinical trials?
Pharmacovigilance helps identify potential safety risks during clinical development, supports regulatory compliance, protects study participants, and contributes to the overall benefit-risk evaluation of investigational products.
3. What types of projects require pharmacovigilance support?
Pharmacovigilance support is commonly required for Phase I–IV clinical trials, bioequivalence (BE) studies, investigator-initiated trials (IITs), medical device studies, and post-marketing surveillance programs.
4. What is an Individual Case Safety Report (ICSR)?
An ICSR is a detailed report documenting adverse events or serious adverse events associated with a pharmaceutical product or medical device, which is submitted to regulatory authorities according to reporting requirements.
5. What are PSUR and DSUR?
PSUR (Periodic Safety Update Report) summarizes the worldwide safety profile of marketed products, while DSUR (Development Safety Update Report) provides annual safety information for investigational products during clinical development.
Protheragen provides integrated pharmacovigilance (PV) services to support sponsors in identifying, evaluating, monitoring, and preventing adverse events throughout drug development and post-marketing stages. Our experienced safety professionals help clients establish compliant PV systems, maintain regulatory readiness, and ensure continuous drug safety monitoring for global clinical programs. Contact us to learn how our pharmacovigilance services can support your clinical development and post-marketing safety programs.