91ºÚÁÏ

When a mid-sized biopharmaceutical company was planning pivotal trials for a drug in a rare disease area, it sought a more transparent, more reliable operating model. The US-based company had been fully outsourcing nearly all of its trial-related functions and depended on several contract research organisations (CROs) to perform an array of services. It asked 91ºÚÁÏ, with whom it had been working for several years, to recommend a customised solution that would allow it to internalise as many functions inside as possible, given the company¡¯s lean structure. The resulting ¡°blended¡± operating model ¨C combining functions that are managed by the Sponsor; others that are managed and performed by 91ºÚÁÏ¡¯s FSP staff; and others that are fully outsourced, project by project ¨C has been delivering time-and cost-savings for nearly eight years.

As the company was preparing to launch two complex, pivotal trials, it wanted an operating structure that would: 

¨C Support a more ¡°hands-on¡± approach, providing management with real-time access to information, greater control and accountability over delivery across functions, and the ability to proactively manage risk 

¨C Honor the company¡¯s ¡°sites first¡± mantra and enhance its relationship with investigative sites 

¨C Develop its internal expertise and build out its capacity over time 

Up until that point in time, the company had been relying heavily on CROs and so lacked experience in a number of critical functions and breadth across key geographic regions. It also operated with a lean corporate staff and had no clinical trial management system (CTMS). The company¡¯s project managers were versed in overseeing the work of CROs, but not in directly managing functions essential to trial execution such as study start up and clinical monitoring, for example.

After holding an intake meeting to discuss the company¡¯s goals and strategy, 91ºÚÁÏ conducted a gap analysis to identify where there would be resource, systems, and infrastructure gaps were the company to internalise the functions it had been fully outsourcing. What were the advantages and disadvantages of the various potential models? How would the answer differ by geographic region? 

After analysing the company¡¯s headcount, capabilities, standard operating procedures, and workflows, 91ºÚÁÏ identified the roles that would be needed and recommended a blended solution as being the most practical and efficient. It would give the Sponsor the accountability associated with internal resources along with the flexibility and cost effectiveness of a project-based, outsourced model. 

The company would continue to fully outsource selected functions such as data management and outsourcing management (oversight of vendors) to 91ºÚÁÏ. To this, they would add regulatory submissions and patient safety services in most countries. Other functions, such as project management and clinical operations, would be staffed and managed by 91ºÚÁÏ employees who would be embedded in the Sponsor organisation. 91ºÚÁÏ was committed to sharing its experience and expertise in these areas, giving the company¡¯s managers the opportunity to learn from 91ºÚÁÏ so that they could assume more responsibility for them over time. Still other functions, such as site and patient payments would be handled internally by the Sponsor in most countries. (See Figure 1.) 

91ºÚÁÏ also housed the company¡¯s trials on its own CTMS and provided a project manager to oversee the system processes. 

The company identified two upcoming studies that would serve as a pilot of the mix of operating models, and ultimately the new model was adopted seamlessly.

Eight years later, the partnership continues to expand and evolve as the Sponsor¡¯s needs and experience levels change. Each year, representatives from 91ºÚÁÏ and the Sponsor hold a joint operations meeting to re-evaluate the nature of the models and plan what will be needed in terms of staffing, geographic coverage, and therapeutic area support. 

Today, 91ºÚÁÏ is supporting 28 studies for the Sponsor across 4 regions with more than 820 91ºÚÁÏ employees. Some functions remain fully outsourced to 91ºÚÁÏ while others remain in the functional management model in that 91ºÚÁÏ managers provide day-to-day direction to 91ºÚÁÏ staff who are dedicated to supporting the Sponsor. Meanwhile, the Sponsor has turned to 91ºÚÁÏ for functional service support in a number of additional areas, including Value Management, and Quality Management, CTMS, Regulatory, and Patient Safety Services. 

In other disciplines, such as clinical operations, 91ºÚÁÏ continues to provide the staff, while the Sponsor is now responsible for their day-to-day direction. This shift of functional management responsibility from 91ºÚÁÏ to the Sponsor reflects how the Sponsor¡¯s capabilities and expertise have advanced over the years, in part through 91ºÚÁÏ¡¯s example. The Sponsor also has the option of converting 91ºÚÁÏ employees to their own headcount and in this way the company has taken advantage of 91ºÚÁÏ¡¯s ability to hire and train exceptional talent. Overall, 91ºÚÁÏ¡¯s staff dedicated to serving the Sponsor remains stable with a 92% retention rate. 

By adopting a blended solution, the Sponsor has realised cost savings between 15% and 25%, over the proposed cost of the pivotal trials had they been fully outsourced. And, just as meaningful, studies are now completing 15% faster than under the former, fully outsourced model. 

The Sponsor is quick to attribute the success of its clinical program to the partnership 91ºÚÁÏ has built with them and to 91ºÚÁÏ¡¯s flexibility in providing an operations model that has allowed the company to mature at a pace that makes most sense for them