Strategic expansion of Clinical Operations support and TMF hub

In July 2024, a global biopharmaceutical client partnered with ICON to strengthen support across several functional divisions. The collaboration began with a limited number of Clinical Operations and TMF roles.

Building on the high quality of ICON’s resources and our agile response to evolving client needs, the partnership steadily expanded beyond its original scope. Over time, new roles were introduced in Clinical Quality, Clinical Systems Expert roles and Late Phase, with ongoing evaluation of future additions in Monitoring, Data Management, and Biostatistics further broadening ICON’s contribution and reinforcing the client’s confidence in our delivery.

After one year of partnership, ICON successfully structured a TMF hub split between the U.S. and India, transitioning and bringing in-house all the work previously carried out by a third-party vendor. Combined with Clinical Operations resources, this integrated model now encompasses over 60 FTEs, enabling more streamlined operations and improved oversight.

The client faced growing operational complexity as its development portfolio expanded, requiring consistent, high-quality support across multiple functional areas. Initially reliant on limited Clinical Operations and TMF resources, the client needed to:

• Explore alternatives to traditional CRO full-service models, as the client had limited visibility and control over operations and budgets with existing third-party vendors, prompting them to bring the work in-house to gain both operational oversight and financial predictability.
• Scale TMF operations globally to reduce costs and improve efficiency.
• Establish inhouse infrastructure to bring back the TMF delivery model previously existed.
• Ensure quality and oversight while transitioning responsibilities away from external vendors.

1. Clinical Operations

ICON provided agile support to the client by assisting with forecasting, planning, and resourcing for key Clinical Operations roles. Our approach ensured that the right talent was in place at the right time to meet evolving program needs. To date, ICON has successfully placed and integrated resources across multiple levels, including CTAs, CTMs, Monitoring Oversight Leads, Project Specialist, Quality Managers, IRT Specialists.

By leveraging ICON’s structured onboarding, governance, and flexible deployment model, the Clinical Operations team has been able to maintain operational continuity, support program expansion, and align closely with client priorities.

2. TMF Transformation Program

Phase 1: Consolidation of TMF operations in India

Client goals and challenges

The client sought to establish a cost-effective TMF delivery hub with a team of 20 FTEs dedicated to TMF document management. India and Poland were assessed as potential delivery sites, with India selected as the preferred location. Key challenges included:

• Lack of existing TMF infrastructure in India
• Concerns from U.S. based TMF managers about managing remotely
• Limited local TMF expertise and time zone alignment
• First-time entry into India for TMF operations

ICON’s structured solution

To ensure success, ICON deployed a delivery model built on governance, flexibility, and phased scaling:

• Leadership deployment: 2 billable Functional Managers (FMs) placed in India, with a 1:10 line management ratio.
• Time zone coverage: Flexible work shifts designed to align with U.S. stakeholder hours.
• Operational oversight: FMs acted as liaisons to integrate client systems, manage workflows, and monitor quality.

Ramp-up approach

• Foundation building: Onboarding of 2 FMs first, ensuring processes and systems were fully aligned.
• Wave-based scaling: 20 FTEs onboarded in four waves of five, ensuring ongoing quality checks and client feedback integration.

Outcome

The phased approach provided stability, scalability, and quality. The client successfully established their first large-scale TMF operations team in India. Functional Managers assumed administrative oversight, reducing client management burden, and ensuring continuous alignment through KPI monitoring and governance reviews.

Phase 2: Transition of U.S. TMF operations from external vendor to ICON

Transition context

Building on the India success, the client-initiated phase 2: transitioning TMF reviewer operations from an external U.S. based vendor to ICON. The plan involved onboarding 16 FTEs in the U.S., in four waves of four, while simultaneously ramping down the vendor.

Challenges

Despite ICON’s streamlined recruitment and onboarding, client TMF managers faced heavy workload pressures:

• Managing the outgoing vendor
• Overseeing new ICON resources
• Maintaining operational responsibilities

ICON’s enhanced support model

• To ease the transition, ICON proposed adding a Senior Lead TMF Specialist who would:
• Act as a “train-the-trainer” for new ICON staff
• Provide structured onboarding and mentorship
• Deliver hands-on TMF expertise during knowledge transfer

The addition of the Senior Lead TMF Specialist accelerated ramp-up, reduced risk, and
alleviated pressure on client managers. This approach enabled the client to focus on strategic oversight while ICON resources became fully integrated and operational.

While operational progress has been significant, the partnership has faced challenges with laptop provision and AWS connectivity, causing frustration for both ICON staff and client managers.

The partnership has evolved into a robust, strategic alliance where ICON demonstrates commercial agility and operational consistency. Multiple work orders have been executed seamlessly, with each new functional division launched through a dedicated kick-off meeting (KOM) to ensure alignment with client priorities.

Looking ahead, the collaboration is set to expand into additional areas such as monitoring and data management, further strengthening ICON’s role as a trusted partner. By combining global delivery capacity with flexible resourcing models, ICON continues to fill critical gaps, deliver cost efficiencies, and provide scalable solutions; reinforcing a partnership built on trust, adaptability, and long-term value.

Through a flexible, phased, and strategic approach, ICON enabled the client to consolidate and expand TMF operations across India and the U.S. while supporting broader Quality and Clinical Operations roles.

ICON’s model provided:

• Cost efficiencies through global delivery hubs
• Reduced client management burden via Functional Managers and Senior Specialists
• Scalable resourcing aligned with evolving client needs
• Operational consistency across geographies and functions
• Proactive IT governance to minimise integration challenges

This partnership showcases ICON’s ability to deliver not just resourcing solutions, but also operational strategy and governance to drive long-term client success.