Long-term benefits of embedded partnerships in biometrics

The sponsor, a prominent, global biopharmaceutical developer based in Japan, sought out ICON’s dedicated data management (DM) resources for their support in several international and complex programs using our embedded 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 ICON’s relationship with the sponsor began in 2004, they have worked with several ICON 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 ICON’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. ICON 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, ICON 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). ICON 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 ICON management team, our resources supported clinical team training and investigator meeting sessions to educate teams on the DM strategy and requirements. ICON 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.

ICON’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 ICON 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.