91ºÚÁÏ

The sponsor, a prominent, global biopharmaceutical developer based in Japan, sought out 91ºÚÁÏ¡¯s dedicated data management (DM) resources for their support in several international and complex programs using our FSP model across several therapeutic areas: oncology, neurology, infectious disease, endocrinology, and nephrology.

The sponsor required a scalable solution to perform quality and systems management to support a portfolio encompassing multiple therapeutic areas. Since 91ºÚÁÏ¡¯s relationship with the sponsor began in 2004, they have worked with several 91ºÚÁÏ teams, including the world leader in functional service provision, Strategic Solutions. Each program was consistently delivered with excellence and met quality standards. The client was delighted with 91ºÚÁÏ¡¯s performance, and their satisfaction was the impetus for expanding their FSP model program.

The project began with data cleaning activities for electronic data capture (EDC) and external data reconciliation and included dedicated operational management oversight. 91ºÚÁÏ was tasked with expanding functions beyond DM (i.e., vendor management and oversight of start-up activities). Our responsibilities and scope continued to grow to include overseeing vendors for laboratories, electrocardiography, radiography, and safety, all of which required specialised knowledge and experienced contributors who could lead the effort and capitalise on these assets.

As part of the portfolio expansion, the client required swift integration with ongoing start-up projects and support with multiple global investigator meetings.

For over ten years, 91ºÚÁÏ provided a scalable team that at one time included 35+ biometrics resources in multiple functions on 15 global studies. Functions included DM, statistical programming, monitoring support, external data and dedicated management (support for recruiting, hiring, onboarding/training, and performance management). 91ºÚÁÏ utilised a centralised hub near the client¡¯s east coast US office to align with the local workforce and company culture, provide an agile response (including face-to-face meetings), and meet other client needs.

Following a quick onboarding process and effective training facilitated by the 91ºÚÁÏ management team, our resources supported clinical team training and investigator meeting sessions to educate teams on the DM strategy and requirements. 91ºÚÁÏ served as the primary point of contact for DM on the global client team. We recruited resources with specialised therapeutic knowledge and technical experience to onboard quickly, deliver quality outcomes, and ensure high productivity.

91ºÚÁÏ¡¯s FSP model provided the client with flexible resourcing and maximum output. The result was the successful completion of numerous database locks and the incorporation of the 91ºÚÁÏ team into the client¡¯s infrastructure. Our client gained full insight and maintained control of trial activities, reduced line management burden for their internal staff, and brought multiple pipeline assets to market, benefiting patients globally.