Having the right organisational design is crucial to your ability to deliver results while minimising operational costs. We have supported over 50 of our clients through organisational re-designs. Each solution is bespoke, configured to our client's exact needs. The models evolve over time to continue to support the changing needs of each business. We offer different levels of ongoing support and are seeing high demand for three core models.

Strategic capacity management

Strategic capacity management provides our clients with maximum flexibility to scale resources up or down in real time dependent on requirements without the risk of large scale hiring of permanent headcount or long term use of contingent resourcing. We combine demand forecasting with our understanding of our clients business and provide time-phased resourcing through all stages of the production schedule.

Centralised hub-based model

Centralising functions in low cost hubs and geographies is an established operational delivery model across the clinical research industry. We have regional hubs for a range of functions including study management, risk-based monitoring, project management and electronic Trial Master File (eTMF). Our teams have extensive experience in supporting sponsors in transforming from a local to regional study management model. For example, within ICON and across several of our FSP clients, our data management and statistical programming footprint is primarily India-based, which has yielded significant cost savings.

We have implemented a growing number of centralised functions including regional clinical trial management which provides a number of benefits including:

  • Flexibility to accommodate an evolving pipeline
  • Optimized efficiency through appropriate use of resource at the local, regional and global levels
  • Sustainable and cost effective model for long term
  • Streamlined interactions, faster decision-making and clear accountabilities
  • Consolidation of CPL roles to regional hubs in lower cost areas can yield cost savings of 25%

On top of these benefits each hub offers advantages specific to the area of expertise, the TMF hub illustrates this particularly well.

 

Trial Master File (TMF) hub

Trial Master File (TMF) hub

We have provided TMF services across internal and client-based systems and SOPs having gained a deep understanding of the best practices for TMF support. With a 250+ strong team, based in centralised low-cost hubs, we are able to provide true end-to-end TMF activities including migration of TMF from Paper to eTMF and vice versa.

In the last 12 years, apart from being a pioneer in innovation, the ICON TMF operational group has developed robust centralised processes to deliver maximum efficiency. During this time we have supported more than 1,000 studies for eTMF related activities, across 30,000 sites in 80 countries. We have processed over 5 million documents in 9 different systems, while working with 90 different clients.

Unit-based model

Moving to a unit-based model reduces risk, freeing up internal management capacity. This approach enables our team to take ownership of the administration and management of the business workstreams from sourcing, onboarding to developing and managing a career-path for all team members. We focus on increasing retention, optimising services and reducing your cost through:

  • Resourcing right fit, regionalised talent with competencies specifically matched to your culture. This is a core competency for our dedicated FSP Resourcing team. For each client we develop customised questionnaires, which identify the right people with the right level of experience and skills.
  • We develop a partnership employee value proposition, creating shared goals and objectives to attract and retain high-quality employees.
  • We use data analytics to algorithmically resource your programme.