Scalable, innovative, and quality-driven regulatory resourcing solution for year-on-year success

A client partnered with ICON to create an efficient, nimble, and cost-effective operating model for their portfolio of work. The partnership goal was to enable their internal teams to focus more time on the core strategic development of pipeline products and decrease the burden of overseeing operational tasks or maintaining established products. The client’s existing operating model did not allow for the needed separation of operational and strategic tasks. In addition, for clinical trial activities, work was duplicated and had diluted accountability through overlapping responsibilities between the client and CROs with limited therapeutic area interface. The client’s operational model prevented detailed workload forecasting, resulting in relying heavily on contractors with limited ability to forecast and optimally resource for the peaks and troughs of work. This fragmented operational model was further complicated by inconsistent regional and/or therapeutic area models, as well as inadequate/outdated internal systems and processes, compromising effective workload and performance measurements.

ICON’s customised approach addressed the client’s early clinical needs, as well as their late development and marketed products. We created a customised solution that allowed the client to focus more time on strategy, design, and data interpretation while retaining critical oversight. Our approach to implementation occurred in three key phases:

Launch and transition

• Transfer of operational capabilities and staff
• Maintain business continuity
• Initial launch of ICON systems
• Capture of historical performance
• Establish baseline measurements

Transform and integrate

• Maintained business continuity through knowledge and process transfer
• Develop initial workload algorithms per function
• Ongoing code review and modification for output/throughput tracking

Innovate and expand

• Resourcing measures across all functions for predictability
• Forecasting process for accuracy and consumption management
• Productivity capture and review
• Efficiency initiative increasing productivity and eliminating stranded capacity
• Introduced value proposition and optimised pricing models as the partnership evolved

During these key phases, ICON’s functional and operational leadership aligned with the client’s goals and assumed the following responsibilities:

• Served as the single partner for broader end-to-end support, including functional services (PV and Global Regulatory Affairs), study delivery, and global efforts, to increase simplicity and harmonisation
• Delivered a fit-for-purpose, efficient model that minimised hand-offs, duplication, and prescriptive processes
• Assumed end-to-end trial delivery responsibilities, minimising duplication, strengthening accountability, and establishing financial risk sharing
• Transitioned ten distinct PV groups covering end-to-end post-marketing activities
• Drove accountability, as defined by a mutually developed roles and responsibilities matrix, for multiple support lines managing and maintaining the marketed product portfolio and the ongoing support for the development portfolio
• Augmented client product teams to provide embedded regulatory services

We implemented an efficient, flexible model without impacting business continuity within the client’s organisation through our organised approach to transition planning and execution. Key achievements of this partnership included:

• Successfully transitioned 275+ team members globally and 350+ in a key market where we previously did not have a presence; these resources comprised the following functions:
  • Regulatory strategy, operations, chemistry, manufacturing, and controls (CMC), labelling, medical writing, medical writing operations (editing and document formatting), clinical trial data transparency, PV, clinical operations, study support, clinical data management and technology, statistical programming, and clinical supplies.
• Ability to leverage team members transitioned from the client for their product, process and systems knowledge enabling seamless delivery of regulatory activities for transferred products.
• Efficient model enabled portfolio-wide, team-centric, and asset-focused decision making.
• At a time of considerable change, ICON successfully delivered key global expansion submissions aligned with client goals.
• No disruption to the portfolio throughout the transformation, with all milestones and timelines met.
• Post-transition year 1 retention rate above 90%, exceeding target.
• Reduced risk to labour workforce by diversifying employee base and offering new opportunities to the existing workforce for future career growth through model transformation.
• Continued portfolio growth, including integration of multiple client-acquired pharmaceutical companies.
• Focus on innovation, including program website, onboarding program, dedicated change management leadership, best practices forum, vendor and system integrations, rewards and recognition program, Centres of Excellence, etc.
• Enhanced capability builds, including global operations, regulatory, and PV platforms.

Notably, our innovative approach, flexibility, and cultural alignment were instrumental in our shared success, and we have continued to grow as our partnership has matured. We continue to invest heavily in our people and focus on transformative, implementable goals.