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How CROs Can Support Pharmacovigilance and Regulatory Compliance?
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:
By outsourcing pharmacovigilance to CROs, pharmaceutical companies can benefit from several advantages, such as:
However, outsourcing pharmacovigilance to CROs also entails some challenges and limitations, such as:
Therefore, pharmaceutical companies need to carefully assess the pros and cons of outsourcing pharmacovigilance to CROs, and choose a trustworthy and reputable CRO that can provide high-quality and compliant pharmacovigilance services. Moreover, pharmaceutical companies need to maintain oversight and accountability for their pharmacovigilance activities, regardless of whether they are performed internally or externally by a CRO. Ultimately, pharmacovigilance is a shared responsibility among all stakeholders involved in the development and use of medicines, with the ultimate goal of protecting public health.
Vigilare Biopharma Pvt ltd is a reputable CRO company 2014, that can provide high-quality and compliant pharmacovigilance services.
Vigilare Biopharma Pvt. Ltd.
Plot no 52,57,1st Floor,
Novel Techpark,Ground floor, #46, Hosur Rd, Krishna Reddy Industrial Area, Hosapalaya, Bengaluru – 560068.
NEW JERSEY, USA
14 Breckenridge LN
Monroe NJ 08831