A top ten pharmaceutical company partnered with ICON to support multiple functional areas, with Trial Master File (TMF) management being one of the key focus areas. The sponsor required standardised reporting, centralised oversight, and a cost-effective solution to ensure global consistency across all studies. The goal was to maintain inspection readiness for both in-house and outsourced studies. ICON responded by designing and implementing a customised model that integrated full operational responsibility with embedded governance and local expertise, supporting a long-term global Functional Service Provider (FSP) environment. This case highlights the success of a decade-long partnership built on innovation, consistency, and operational excellence which paved the way for eTMF Hub.

The sponsor was managing multiple concurrent studies across global locations and sought a new provider to ensure consistent TMF documentation, regardless of study lead or site location. 

Key challenges included:

• High costs: High operating costs associated with staff and full-service models
• Time zone coverage: The need for highly skilled support across multiple time zones
• Quality standards: Meeting rigorous quality expectations
• Cost efficiency: Identifying and implementing cost-effective measures

ICON’s Operations, Talent Acquisition and Human Resources teams designed a customised approach to the sponsor’s expectations. To address the challenges, ICON provided expertise to develop custom, responsive solutions including:

• Structured oversight: A dedicated team with strong leadership and governance
• Strategic recruitment: A talent attraction strategy focused on sourcing highly skilled professionals which resulted in cost-effective measures for resourcing
• Operational efficiency: Seamless systems and processes for resource management and training aligned with quality expectations to meet quality expectations of sponsor
• Optimised budgeting: Cost-effective operations for program management to manage high cost involved in other models
• Seamless global coverage: The necessity of highly skilled support across multiple time zones is resolved by setting up team in India & Mexico to have 24-hour support for sponsor

ICON’s eTMF hub successfully completed a comprehensive review of the sponsor’s eTMF within the specified timeline. Over 4.5 million documents were filed, reviewed, and made inspection ready, resulted in enhanced productivity and efficiency while maintaining high quality. Centralising TMF document management enabled the sponsor to remain inspection-ready across all studies and geographies, while also reducing costs. 

ICON eTMF Team has experienced phenomenal growth, expanding from 14 to over 130 talented professionals with diverse expertise and career levels, all committed to delivering exceptional support to our valued sponsor. 

Key outcomes included:

• Regulatory adherence: On-time filing of all documents in required formats and in compliance with regulatory standards
• Precision delivery: High-quality deliverables, with additional quality checks to meet both sponsor’s and regulatory expectations
• Adaptive solutions: A customised approach tailored to specific tasks
• Impact training: A tailored training program aligned with business requirements
• Agility: Flexibility and adaptability in managing process change and transition smoothly

With its established and proven FSP model of TMF management, ICON leveraged its expertise and experience to establish an eTMF hub. In 2024, two global pharmaceutical clients partnered with ICON to strengthen and streamline their TMF operations. Through its long-term partnership model, ICON operates as a centralised, unit-based TMF management team while maintaining the agility to provide tailored solutions for each client’s needs.

ICON’s structured solution for two new sponsors.

FTE Model: ICON deployed a dedicated TMF document management team under an FTE-based delivery model, built on operational excellence, functional oversight, phased team ramp-up, and flexibility; deployed 2 billable Functional Managers (FMs) placed in India, with a 1:10 line management ratio.

BOT Model: For another client, ICON implemented a customised BOT (Build, Operate, Transfer) model, focusing on governance, operational excellence, functional oversight, and scalability.

• Successful partnership: Our long-standing partnership has delivered high-quality services, built trust and driven growth.
• New client implementation: Building on this success, we have leveraged our expertise to win new clients, expanding our footprint in the pharmaceutical industry.
• Additional sponsor onboarding: We have also successfully onboarded an additional sponsor, further solidifying our position as a trusted partner.
• Standardised reporting: Ensuring our solution ensures standardised reporting, enabling seamless monitoring and oversight across studies.
• Cost effective solution: Our efficient operating model has delivered significant cost savings while maintain exceptional quality.

• Ramp up 14 to over 130 FTE across India & Mexico
• Quality Compliance with continuous learning for the team achieved with training conducted on regular intervals, brainstorming session on new updates from sponsor
• Exclusive sponsor support during holidays with limited number of resources so that document review is undisturbed for 24h timeframe
• Structured management model with multiple layers of hierarchy maintained by creating different roles in the hub location which resulted in career progression within the team
• Team expertise including document completeness, reduction in cycle times and risk-based monitoring which resulted in real-time inspection readiness, ensuring the system is always ready for regulatory review
• Regular team engagement activities, creating a supportive environment for the team resulted in career enhancements and retention more than 85%
• Successful completion of over 2 million documents within 6 months with the new sponsor on 80 studies in multi therapeutic area for FTE model

This specific partnership delivered high-quality products in TMF management, exceeding client expectations and setting industry benchmarks through collaborative innovation and expertise for over a decade. This case study highlights ICON’s proven record of success, driving efficiency and operational excellence which paved the way for the creation of eTMF Hub in ICON.