Pharmaceutical companies have been challenged with increasing demands on internal resources, while at the same time, economic pressures have been forcing executives to scrutinize operating costs. Together, these two forces—increased workloads and shrinking budgets demand that managers develop effective strategies to “do more with less.”
One proven approach is to adopt a sourcing strategy. Recent forays into outsourcing clinical data management, coupled with increasing numbers of strategic sourcing partnerships, suggest improving prospects for pharmaceutical companies to source critical operations. Selecting the “right” option for your business will depend on specific organizational needs.
Given the long-term, cost-effective sourcing solutions—offshoring and internal (captive) offshoring—the sponsor company needs to determine, early in the process, whether an internal (captive) offshoring solution exists.
For a large pharmaceutical or biotech entity, the most attractive sourcing alternatives are typically for large clinical data management centers that already handle data from clinical studies in high- and/or low-cost markets.
Depending on the corporate strategy for outsourcing regulated activities, these internal organizations may already enjoy a long-term, strategic commitment from senior management. However, these internal organizations may represent key candidates themselves for current or future sourcing. Either way, senior management may find it difficult to evaluate and agree on an outsourcing solution where the recommendation is misaligned with the corporate strategy.
The identification of sourcing solutions, definition of activities to be sourced, and evaluation and implementation of a realistic solution all represent a daunting task. Furthermore, outsourcing regulated activities presents unique challenges in quality and compliance. With a proven, methodical approach, Scimitar can help you successfully overcome these challenges, resulting in a new operating model that enables a dramatic reduction in cost with increased capacity, as well as new capabilities.
Top-5 Pharmaceutical Company: Clinical Development & Drug Supply
Rising resource costs in the US and EU markets coupled with a limited supply of qualified resources continued to drive-up their product safety budget.
Cost pressures and headcount restrictions required management to consider off-shoring solutions to significantly reduce overall product safety cost structure and provide greater scalability.
Concerns over quality, confidentiality, and privacy concerns fostered apprehension among the drug safety organization.
Approach & Outcomes
- Mapped key AE handling processes, identified key activities, and completed a core / non-core assessment
- Collected and analyzed vendor responses from a dozen global CRO and BPO providers, as well as, an internal data management organization
- Facilitated the successful evaluation of an optimal sourcing strategy
- Developed implementation plans and execution strategy