Improving R&D Operational Effectiveness through Outsourcing Medical Writing

Regulations at a global, national and regional level are becoming increasingly complex, and many organizations are finding the task of complying with these regulations a major challenge. In the wake of recent high-profile corporate failures, many regulations have become even more stringent, making compliance an expensive endeavor. Apart from necessitating a sizeable monetary commitment, efforts to comply with regulatory norms also require the time and attention of several employees, often at the cost of other more important projects. This increases strain on a company’s bottom line and makes it imperative for an organization to seek alternative solutions.

The economy of Outsourcing is quite evident, and companies struggling to cope with mounting regulations should consider the option of outsourcing at least some compliance related functions to a low-cost outsourcing destination. Apart from cutting costs, this initiative will free up critical work force resources, improve focus on business activities and enhance competitiveness. Although Outsourcing is currently limited to a few functions in the pharmaceutical industry, the trend is likely to shift to other tasks as well.

This Paper aims to provide a high-level view of Outsourcing medical writing to low-cost destinations. It provides an overview of the regulatory environment in the pharmaceutical industry and the costs associated with compliance. An argument for the Outsourcing of compliance-related functions is also presented, including the rationale for doing so and an assessment of functions most suited for Outsourcing. Issues that may thwart the decision to outsource are also discussed, and an outline of the technical and other capabilities required to ensure success are covered. Finally, we present Patni’s Life Sciences capabilities and its experience in the Life Sciences arena.