Staff augmentation and the CRO model have long been the only choices when biotech companies need to look beyond their full-time staff to get work done. Each of these two models still have their inherent value propositions but a 20-year career in the staffing and services industry has revealed many lessons learned. Most notably is the realization that often customer needs are best met with a customized solution in which stakeholder-ship is carefully calibrated for the unique goals and challenges at hand.
Staff augmentation is typically sought after for its ease of engagement and flexibility while the true outsource is best when you need the tools, thought leadership and skin in the game to achieve the outcomes you seek. A trend with key sponsors is the call for engagement models that allow them to maintain control of project direction while still getting a solution that has defined accountability to business outcomes.
Many sponsors have invested heavily in tools, SOP’s and now organizational standards for development and data management. This reality reduces their dependency on fully outsourcing a project to a CRO that brings these tools to the table. The preference is shifting towards finding specialized partners to do work inside their established environments to avoid rifts with organizational standards as well as the challenges and costs associated with accessing outsourced trial data.
Sponsors often have the thought leadership in house and primarily need resources to execute established project plans. The staff augmentation model that was so widely used is now governed by strict tenure rules to mitigate co-employment risks presenting a significant challenge to multi-year efforts.
The most progressive leaders in biopharma are calling for solutions that start with a partner’s ability to deliver highly skilled teams but they require more than the traditional staff augmentation model can offer. The perfect space between staff augmentation and full service outsourcing must be determined at a project level so that the sponsor receives a service framework in which their chosen partner is accountable to the outcome without sacrificing the control and flexibility the sponsor desires. Full outsourcing drives up costs as the partner brings with it more tools, resources and overhead than necessary to achieve project goals. Conversely, when relying only on resourcing, the burden of project execution lies solely on internal resources. When the service attributes and measurements are developed for the unique needs of the project, no more and no less, the customer achieves an optimal value proposition.