Outsourcing Pharmacovigilance to CROs: Benefits, Challenges and Best?Practices

Pharmacovigilance is the process of monitoring, evaluating, and preventing adverse reactions or any other problems related to medicines. It is an essential part of drug development and post-marketing surveillance, as it ensures the safety and effectiveness of pharmaceutical products for patients and consumers. However, pharmacovigilance is also a demanding and complicated task, as it requires gathering, processing, reporting, and managing large amounts of data from various sources, such as clinical trials, spontaneous reports, literature, social media, etc. Furthermore, pharmacovigilance is subject to a dynamic regulatory environment, as different countries and regions have other laws, guidelines, and standards for drug safety monitoring and reporting.

This is where contract research organizations (CROs) can be crucial in assisting pharmaceutical companies in their pharmacovigilance activities. CROs provide research services to the pharmaceutical, biotechnology, and medical device industries on a contract basis. CROs can offer a variety of pharmacovigilance services, such as:

• Planning and conducting pharmacovigilance studies, such as post-authorization safety studies (PASS), post-authorization efficacy studies (PAES), risk management plans (RMPs), etc.
• Setting up and maintaining pharmacovigilance systems, such as databases, signal detection tools, quality management systems, etc.
• Performing pharmacovigilance tasks, such as case processing, literature review, signal management, periodic safety update reports (PSURs), risk-benefit analysis, etc.
• Providing pharmacovigilance training and consultancy to staff and stakeholders
• Communicating with regulatory authorities and healthcare professionals on pharmacovigilance issues

By outsourcing pharmacovigilance to CROs, pharmaceutical companies can benefit from several advantages, such as:

• Accessing specialized expertise and experience in pharmacovigilance
• Reducing operational costs and risks associated with pharmacovigilance
• Enhancing efficiency and quality of pharmacovigilance processes and outputs
• Increasing flexibility and scalability of pharmacovigilance resources
• Complying with local and global regulatory requirements and standards

However, outsourcing pharmacovigilance to CROs also entails some challenges and limitations, such as:

Vigilare Biopharma Pvt ltd is a reputable CRO company 2014, that can provide high-quality and compliant pharmacovigilance CRO?services.