Large scale transformation delivers lasting results in clinical monitoring

More than a decade ago a top five biopharma company made the radical move to transform the delivery of their entire clinical site management activities through Functional Service Provision (FSP). This was one of the first times that a sponsor chose to use FSP to deliver services across such a large and important function. During this collaboration, year-on-year, ICON Strategic Solutions has increased our footprint in site management responsibilities across all regions globally and currently support over 15 countries including their top 5 across all regions.

Our client wanted to work with a trusted partner that could support its site management function and apply a proactive approach to continuous innovation.

When our client first introduced FSP to their global clinical monitoring function, we were one of a complex matrix of local providers. Over time we were able to show our client that this approach was inefficient and causing significant management oversight for them internally. 

We worked with them to reduce the number of suppliers in order to simplify and standardise the programme. Specifically, we focused on enhancing the overall quality, increasing productivity while reducing their work burden and overall costs by a target of 30%.

Additionally they made a significant pipeline shift towards complex early novel Oncology, which required new specialist skillsets to meet highly aggressive development timelines. A number of our competitors failed to deliver the required resource, endangering our client’s important deadlines resulting in the transition of four countries.

From implementation we successfully grew a team from an initial 250 to over 400 people across Europe and the Americas. Our vision for this partnership included:

1. Rapid, quality country transitions ensuring business continuity and delivery

We worked collaboratively with our client, forming joint transition workstreams which allowed us to build deep knowledge of the programme risks and priorities, the types of studies, skills and experience needed. We implemented a strategic plan to deliver the right resource at the right time, enabling the rapid on-boarding of the team. This included developing best-fit candidate profiles, leveraging ICON’s therapeutic and technical expertise to deliver induction, client-specific training, and any role-based training needed to ensure excellence in delivery and quality oversight

2. Data driven approach that delivers deepened insight

We provided our client with deep insight into the real-time operations of the function driving speed and predictability in study execution through the dynamic quality and oversight metrics platform we created. This enabled a highly effective resource strategy, allowing accurate forecasting, delivering on-demand supply and eliminating unnecessary resource allocation.

3. Framework to support continuous evolution of pipeline 

We developed a framework to assess the performance of sites in real-time through a quality trigger process which included a set of predefined actions to rapidly mitigate any risks and address issues. Additionally we introduced a new country-specific Study Start-up (SSU) role which enabled speed and predictability in the start-up process. Both quality assessment and SSU process enhancements have been so effective that our client has rolled them out as standard across their entire business. 

With the change in focus to complex early novel Oncology we developed and rolled out therapeutic specific training, real-world workshops and oversight as well as advising on adjustments in the resourcing models. In parallel, we also adjusted the number and location of our resources to meet specific study milestones. This involved re-deploying over 100 staff and flexing the overall size of the team by up to 50% at any time.

Monitoring productivity has increased by over 60% and cycle times for site initiation and study execution reduced by more than 20% in each region. We have delivered a specialised and best in class training platform for CRAs to support a growing novel modality pipeline. We continue to share innovations and best practices to support quality, speed and efficiency in clinical trial delivery from a site management perspective.