PAREXEL understands that requirements regarding post-marketing safety monitoring are more stringent now than ever. Numerous incidents involving marketed pharmaceuticals and over-the-counter (OTC) medicines in recent years have brought the issues of safety monitoring and risk management to the forefront of public attention and regulatory scrutiny in the United States, Europe, and elsewhere around the world. However, the current financial climate is generating significant pressure on the pharmaceutical industry to reduce costs, increase efficiency of routine operations, and concentrate limited resources on core competencies. Conflicting demands for expanded safety monitoring processes and lower costs create a significant dilemma for industry executives, who must adhere to both imperatives.
One established strategy to address both of these demands is to leverage external resources to handle routine non-clinical study, post-marketing safety requirements. This cost-effective alternative allows bio/pharmaceutical companies to lower the cost of safety monitoring, whilst ensuring they meet all regulatory requirements and post-authorization commitments. In addition, companies can utilize safety outsourcing to enhance both quality and reporting compliance for marketed products – without increasing fixed expenses. Equally important, this approach gives internal resources more time to focus on strategic safety and regulatory priorities to increase revenue and protect asset value.
PAREXEL's patient safety services have been specifically designed to help bio/pharmaceutical companies meet increasing post-marketing pharmacovigilance obligations. When combined with PAREXEL’s established global infrastructure in drug safety management, extensive safety consulting expertise and leading capabilities in post marketing authorization safety studies, enables us to offer the next generation of post-marketing pharmacovigilance services. As a pharmacovigilance partner, we can provide a global strategy for a cooperative partnership in post-marketing pharmacovigilance.
PAREXEL's patient safety services provide the capacity to enable us to rapidly ramp-up services provided to biopharmaceutical companies. Using our global safety experience, processes, and infrastructure we are able to deliver a flexible range of safety monitoring services to precisely compliment our client's internal resources.
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We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.