A top 20 pharmaceutical partner wants to minimise operational and infrastructure costs for Clinical Operations whilst retaining key operational control, maximising market access and enabling greater flexibility of workforce capacity. Our experienced, dedicated employees integrate seamlessly into the sponsor’s organisation to provide culturally aligned resources across a range of models, including a blend of FSO, FSP, stand-alone and specialty services.

The sponsor needs a consistent platform and flexible services and resourcing to adapt to a range of models. The sponsor wants to expand the partnership across the enterprise to facilitate a wider range of outsourcing models while providing the infrastructure and optimised internal capabilities to deliver a study or program in house. However, the scale of the geographic footprint, existing outsourcing relationships with other providers and internal infrastructure offered opportunities to streamline for efficiencies while affording consistent platform, branding with Investigators & Institutions, and appropriate level of oversight and engagement with Country Teams & Operations.

ICON presented a strategy that wraps our extensive capabilities around an embedded (FSP) solution core to create a “blended” delivery model unique to the client’s needs that could shift to cover emerging requirements and multiple models all under a single point of delivery. The blended model leverages ICON knowledge and organisational intelligence, driven by shared metrics and KPIs to maintain high levels of performance with localised oversight and clear escalation pathways to ensure transparent, efficient problem-solving.

Bespoke models with unitised services:

Utilising ICON’s infrastructure and a unitised services model as a supplement to the FTE model allows for flexibility and cost-effective resourcing during capacity peaks. This model replaces the need for the client to maintain local or global internal capabilities and provides a clear contract framework to avoid the complexity and burden of project level change orders. Combined, this enables bespoke solutions to add to the FSP team and overcome constraints to delivering a study or program in-house and flexes to allow project tasks to be managed promptly and variably month- to-month to match requirements.

Strategic footprint analysis and country rationalisation for flexible scalability:

Sponsor footprints grow and contract as needs change to ensure optimised operations. The proposed enterprise-level blended solution for the client supports efficient extraction and expansion into new countries by providing the staffing necessary, meaning the client can conserve resources by not staffing each location. ICON also supports site feasibility to adjust and refine the site list. On a recent high-priority study, the sponsor wanted to accelerate the startup timelines without compromising quality and ICON enabled this process by providing a data-driven list of high-performing sites.

Optimised internal infrastructure:

Implementing this blended model allows the sponsor to meet protocol-specific requirements without needing to build permanent in-house capabilities, e.g., in-home services. Enterprise-level partnership governance enables portfolio review and consultation to identify opportunities to reduce spend and increase direct control through managing more studies in-house.

As consultative partners, ICON can also assist during the sponsor’s internal audit of capabilities and services to identify the most efficient and cost-effective opportunities to either outsource or bring services in-house. We reviewed opportunities around the following areas and have made suggestions to the client, some of which are already underway:

• Medical Writing
• Site Networks
• Contracts & Budgets
• Patient Recruitment & Retention Campaigns
• In-Home Services
• Drug Development Services
• Study Start Up

ICON worked with the sponsor to identify areas to optimise and flex internal capabilities for greater control, transparency and custom solutions that utilise services, functions and technology from across the broader ICON organisation to fulfil their business objectives.

ICON has implemented blended models across core and non-core assets within several countries, and these have been operating successfully since 2020 in Chile, Philippines, South Africa, Thailand and Vietnam. The sponsor programs have benefitted through cost savings, streamlined trial conduct faster start up timelines and greater control. Based on these successes, we are expanding our partnership with a 3-year plan for a more heterogeneous mix of blended solutions across the enterprise.