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Ensuring Success in Pharmacovigilance and Patient Safety

Best practices for sponsor and CRO alliances in a demanding industry

Outsourcing all or part of the pharmacovigilance (PV) and patient safety services required during a project lifecycle is common practice in the current market. Ever-evolving demands and increasing regulation present additional challenges to determining the best solution for your PV and patient services needs. We explore opportunities for outsourcing these services, potential models, and best practices for selecting a service provider and establishing a successful relationship.

Outsourcing pharmacovigilance and patient safety activities have become a standard business practice within a continuously expanding market segment. Innovations and rapid changes in technology and regulatory environments have created opportunities for sponsors to re-evaluate their requirements for successful outsourcing of their pharmacovigilance and patient safety obligations. While outsourcing provides access to unique expertise, specialised intellectual property, multidisciplinary knowledge and an unbiased view, there are certain challenges associated with the increasingly competitive market. These challenges include stricter regulatory environments with variations across the globe, a wider range of safety indicators and a higher demand for transparency that puts added pressure on biotech and pharmaceutical companies, especially within the pharmacovigilance and patient safety scopes.

Choosing a service provider that is qualified to meet your needs is crucial to the success of your program. Outsourcing PV and patient safety can lower costs for staffing (based on reduced effort), recruitment, management and training. For organisations operating globally in the pre-and/or post-marketing setting, outsourcing PV can also provide improved access to important resources in non-traditional cost-effective regions. With the right service provider, the partnership can result in innovative solutions that maximise the value of the product portfolios while improving patients’ lives. In this article, we explore opportunities for outsourcing these services, potential models and best practices for selecting a service provider and establishing a successful relationship.