Scaling an optimised global vaccine trial with flexible FSP for 15-year partners

ICON partnered with a top pharmaceutical company to scale their global vaccine program with custom FSP solutions designed to optimise resourcing. This collaboration focused on flexibility, transparency and operational rigor to meet the unique demands of vaccine development. ICON has helped the sponsor globalise their vaccine trial footprint effectively and efficiently through a blended FSP approach that combines dedicated teams with on-demand support services. This approach helped maintain quality, rapidly scale to meet shifting trial demands, and achieve nearly $10m in cost savings in a single year.

Vaccine trials are highly variable. Enrolment rates and resourcing requirements can shift significantly from day to day, adding to the challenge of scaling across geographies. Global expansion provided access to more participants and introduced additional complexity, especially in regions with minimal volume, where assigning full FTEs wasn’t practical. The fast-paced operations required staff who understood the nuances of vaccine protocols and could execute quickly without compromising quality. This knowledge is vital for vaccine trials as a single procedural error, such as a missed centrifuge window, can invalidate an entire participant’s data and impact quality and integrity. 

The sponsor needed a model that could scale quickly, flex intelligently and deliver high-touch quality, all while remaining financially transparent.

ICON implemented a custom blended solution utilising a hybrid FSP model tailored to the sponsor’s needs. The model combined an embedded ore FTE team with flexible resourcing to manage fluctuations in trial demand and regional variability. This blended model enabled consistent study management, monitoring, and data support as well as vaccine-specialised teams. Internal vaccine training and curriculums ensured a pool of highly-qualified, consistent experts ready to manage high-speed enrolment, cold-chain logistics and critical quality points. 

Flexible, proactive resource management integrated shared resources across funtional areas that could be delivered on different contract models—either time and materials or unit-based, improving scalability. Although the model operated at the program level, ICON structured financials study by study. This enabled the sponsor to clearly attribute costs, monitor burn rates, and gain the budget visibility needed for rapid decision-making. This also allowed cost savings to be shared across the portfolio. Functional managers tracked contracted vs. actual FTE usage in real time, enabling resource reallocation with speed and precision. 

ICON provided a dedicated regulatory team for the program with a focus on study startup and TMF quality. This approach supports consistent quality control for documents and ongoing uploads to the sponsor’s Trial Master File (TMF) throughout the study, through closeout, and for audit and inspection preparation.

Over the course of the partnership, this hybrid model has delivered measurable value across operations, resourcing and finance while facilitating global expansion. In the last five years, this collaborative relationship has supported the sponsor’s global growth goals, now with trials in 33 countries.

Global operational impact

The scalability of this model allowed the operations to grow from 12 US-based FTEs to a global footprint of nearly 300 team members without disrupting delivery models. As a result, the sponsor has had a 56% increase in the number of active trials with 51% of trials including sites outside of North America.

Resourcing flexibility

The resourcing structure enabled rapid expertise deployment during unpredictable enrolment surges, including successful resourcing for a study that enrolled 600 subjects in one month. The program saw reduced cost and reduced need for CRA FTEs during the startup period. Additionally, the program benefitted from improved retention rates in key roles and expanded resourcing for specialised support roles.

Financial efficiencies

ICON delivered full transparency with study-level invoicing and burn-rate tracking, aligned with sponsor’s internal budgeting requirements, and maintained lean, proactive resourcing. As a result, ICON saved the sponsor $9.9m in a single year across the program.

Quality and inspection readiness

ICON’s training and quality plan included collaboration with the sponsor team. As a result of clear governance and metrics, the program improved quality metrics related to sponsor audits and regulatory inspections. There were approximately 12 regulatory inspections a year with no 483 or critical findings and no critical findings across an average of 15 sponsor inspections per year. By combining embedded expertise with a responsive support model, ICON has helped the sponsor anticipate and keep pace with vaccine trial demands.