91ºÚÁÏ

After relying on as many as five different contract research organisations (CROs) for all aspects of trial execution, a mid-sized biotech company wanted to bring its clinical development operations in-house. The China-based company decided upon the strategy as a way to save costs. But what was the best way to proceed, given the mix of players, the company¡¯s lack of experienced staff, and the number of trials in progress? The Sponsor had been trusting 91ºÚÁÏ for full-service support in data management and biostatistical programming, and the company¡¯s positive experience in that relationship led it to approach 91ºÚÁÏ for a solution.

The Sponsor recognised that moving to a functional service provider (FSP) model would meet its cost-savings goals, as the approach commonly cuts trial costs by approximately 30% over a full-service model. An FSP model, through which a CRO partner¡¯s staff is embedded in the Sponsor¡¯s team, would also be a way for the company to gradually build out its resources and infrastructure ¨C particularly outside of China. Even the company¡¯s program leaders lacked functional expertise; their focus had always been on managing the work of CRO partners who oversaw day-to-day functional operations.

The company was, however, in the midst of conducting two long-running oncology studies and did not want to simply apply the new model as new studies launched. Moreover, the company wanted to consolidate its partnerships and work with two CROs, rather than five (or one). And, it wanted to divide FSP awards between the two selected CROs by country. In other words, all functional services in a given country would be handled by a single provider, and that provider could differ country by country.

To add to the complexity of the challenge, the Sponsor had not identified a transition process, but rather had turned to each of its five CROs to make recommendations. These, naturally, were different from one vendor to the next. Each CRO had its own processes and suggestions for how best to make the transition.

91ºÚÁÏ performed a gap analysis to fully understand the Sponsor¡¯s needs and current capabilities. Based on 91ºÚÁÏ¡¯s assessment, the company adopted a model that would meet its goals in the most efficient way:

• 91ºÚÁÏ continued its full-service responsibilities in data management and statistical programming and added the client¡¯s regulatory and patient safety functions to this model. The Sponsor also turned to 91ºÚÁÏ for legal representation as needed around the world.
• The company converted clinical operations, clinical monitoring, project management, and study-start-up activities outside of China to an FSP model, which 91ºÚÁÏ assumed in selected countries. This meant that 91ºÚÁÏ had to hire 110 full-time employee equivalents in a span of three months to meet the Sponsor¡¯s needs. 91ºÚÁÏ staff were then trained using the same programs and development techniques as the Sponsor¡¯s internal team.

As time has passed, 91ºÚÁÏ has helped the Sponsor progress toward even greater efficiencies and independence. 91ºÚÁÏ proactively offers suggestions on how the Sponsor¡¯s processes might be optimised, developing innovative tools and promoting standards of excellence. And, as the client¡¯s management team has developed in the EU, 91ºÚÁÏ has helped the company assume functional management responsibilities for 91ºÚÁÏ¡¯s embedded staff, while 91ºÚÁÏ retains line management responsibilities. Thus, 91ºÚÁÏ is operating in a truly blended model: part full service/ part FSP, and within the FSP, providing only line management oversight in some cases and in others, both line and functional management oversight.

Currently, 91ºÚÁÏ employs more than 300 people who support the Sponsor. The fact that each year the Sponsor hires about 15% of these people directly points to the quality of the talent that 91ºÚÁÏ recruits and trains.

Another testament to the company¡¯s satisfaction with 91ºÚÁÏ¡¯s service and a sign that it is achieving its cost-savings goals is that it has adopted the FSP model in China, where all trial-related functions had previously been handled in-house. The fact that 91ºÚÁÏ maintains staff in China, ensuring that there are no language or time-zone issues has made the transition seamless.