Outsourcing pharmacovigilance and patient safety activities is a standard business practice in a continuously expanding market segment. Because of the changing technology and regulatory environments, sponsors are reevaluating the advantages and disadvantages of outsourcing their pharmacovigilance obligations. The benefits of outsourcing include lower costs for staffing (based on reduced effort), recruitment, management, and training, along with access to resources in non-traditional cost-effective regions (e.g., the Philippines, India, Latin America, or China). Sponsors also gain access to unique expertise, intellectual property, multidisciplinary knowledge, and an unbiased view. However, with stricter regulatory requirements, the hiring of experienced safety personnel has become highly competitive. Varying regulations across the globe, new technologies, a wider range of safety indicators, and a higher demand for transparency put continuous pressure on biotech and pharmaceutical companies; one of the most affected functions is pharmacovigilance and patient safety.

Sponsor and CRO Pharmacovigilance and Safety Alliances

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