ICON was selected by a Top 10 pharma company in 2012 to serve as a key CRO provider for global clinical research operations. Over the past 13 years, the client’s priorities and strategies have shifted, resulting in significant evolutions in outsourcing models and the expectations surrounding the partnership (services contracted, resources required, SOPs and systems). ICON has implemented strategic partnership with blended solutions to flex to fit the client’s changing needs and has demonstrated the agility and ability to mobilise new strategies, all the while ensuring quality delivery and client satisfaction as the partnership scaled.

The sponsor required a CRO partner that could adapt and optimise new delivery models to meet the needs of their evolving pipeline which includes vaccines, oncology, GI, immunology and rare disease. The primary outsourcing models and scopes have changed significantly over the years and have required strategic implementation to support future growth.

The sponsor also wanted to scale up global operations and implement more cost management strategies, and required rapid mobilisation to ensure targets were met even as outsourcing models shifted. As part of the cost management strategy, the sponsor wanted to scale the FSP, requiring internal infrastructure and cross-divisional and cultural alignment.

The sponsor prioritised speed, flexibility and efficiency and needed solutions that could deliver quality in a highly dynamic environment in preparation for a shift to FSP-majority model in 2024.

Strategic partnership

ICON established a sponsor-dedicated business unit to provide high visibility with single point accountability and leadership to facilitate deeper collaboration and transparent communication. ICON’s robust change management methodology included Change Ambassador roles to ensure proactive cultural alignment and support reinforcement of the sponsor’s internal infrastructure to enable new models and seamless transitions. Strong collaboration between internal FSO and FSP teams under our unified approach provided continuity and seamless integration of resources as models shifted and our commitment to strong partnership governance provided clarity and increased control and responsiveness for strategic decision making.

Agile, scalable strategies

ICON leveraged an agile and adaptable resourcing strategy that could flex to accommodate different models used over time and across geographies. The implementation of strategic hubs in key regions supported rapid mobilisation and scalability, especially as the sponsors expanded from mainly North America to more global operations. The regional hubs were carefully selected to enable cost-effective up- or down-scaling of operations in key areas to fit evolving sponsor needs and interests.

Responsive resourcing

Centralisation initiatives deployed hubs in Remote Monitoring and Clinical Trial Administration to ensure globally available, responsive resourcing. ICON constantly evaluated the resource pool and consistently trained new staff to accommodate increased resource needs as appropriate. Standardised, robust training ensured high levels of fidelity across operations. ICON also dedicated resources across therapeutic areas, enabling greater knowledge retention and continuity to foster site relationships.

Cost and risk management

ICON delivered cost-effective structures and solutions that minimise risk within dynamic, flexible strategies, including the deployment of a global risk-based resourcing model to ensure sufficient coverage during peaks in activity.
We proactively managed risks with increased review of shared and individual Key Performance Indicators (KPIs) and program milestones. Transparency and real-time access to information via trackers, SharePoint, etc. allowed for clearer, faster insight into the status of new implementations, meaning any data trending toward risk could be more actively addressed with the appropriate solutions.

ICON’s blended solutions model provided the high degree of responsiveness and flexibility the sponsor needed, rapidly scaling the partnership to more than 300 FTE within a period of three months without compromising the quality of deliverables. The next-stage shift to FSP was successfully executed in a compressed timeline, with the
partnership now comprised of 521 FSO FTE and 653 FSP FTE as per March 2024.

The cost management strategies built into our responsive resourcing hubs resulted in direct savings for the sponsor, and the overall adaptability of the blended model solutions allowed the sponsor to reduce the number of vendors contracted to deliver at a global scale, saving time and resources.

Our dedication to strategic, consultative partnership and cultural alignment supports deeper efficiencies within dynamic outsourcing models. This flexible collaboration and ability to seamlessly transition between operational models led to achieving >90% of key milestones on or ahead of schedule.

The high quality and timeliness of delivery within flexible models has contributed to our high customer satisfaction scores, our rank as the sponsor’s #1 provider across all delivery areas and the continued expansion of our +13 year partnership.