Under The Microscope

Curated and customised outsourcing

Posted: 21 November 2024 | | No comments yet

As the outsourcing market evolves, pharmaceutical businesses are reassessing their strategies to better insulate themselves against the pressure of compounding macroeconomic constraints, including a looming patent cliff, rising costs and developmental risks. Sponsors are adopting more intelligent, blended models that seamlessly integrate functional service provision (FSP), full-service outsourcing (FSO), standalone and specialty services. These custom solutions offer improved accountability, transparency, flexibility and efficiency, helping sponsors manage risk while maintaining greater control over their clinical development processes.

Why is more intelligent outsourcing a priority?

Cost efficiency and quality are more important than ever as clinical trials become more complex and costly. More strategic outsourcing allows sponsors to optimise the models they use to generate efficiencies that benefit their clinical development programmes, support wider business objectives and improve their returns on investment. Recent trends among large pharma show an increasing demand for simultaneous deployment of FSP and FSO services in an interoperable infrastructure to harness the best elements of both. In effect, sponsors want custom, blended solutions optimised to meet their needs.

How do blended models solve sponsor challenges?

Embedded resourcing in blended models enables enhances financial effectiveness, while ensuring operational flexibility”

Among the challenges that sponsors seek to resolve through blended outsourcing are accountability, control over core/non-core assets, flexibility, cost efficiency and risk management. Global resourcing and access to specialised expertise can also pose significant challenges for pharma sponsors as the geographic footprints of their programmes expand and contract with their studies. Embedded resourcing in blended models allows sponsors to align between full-time equivalent (FTE) and unitised (FSO) pricing structures. This flexibility enhances financial effectiveness, while ensuring operational flexibility.

Does blended outsourcing look the same for everyone?

A blended model is not one-size-fits-all. An experienced CRO partner knows this and will consult with sponsors to identify and prioritise the strategic objectives (ie, cost efficiencies, increased utilisation) which will inform the ideal configuration of outsourcing architecture.

As sponsor needs change, blended outsourcing can accommodate the deployment of different models, or versions of models, across the CRO-sponsor partnership to support sponsor objectives”

Large and midsize pharma have similar desires from a blended model but will likely require different elements. For example, large pharma may leverage their own infrastructure and will benefit from the flexibility to scale staffing as their portfolio needs shift or take advantage of continuity provided by a dedicated business unity. Midsize pharma, on the other hand, have a less straightforward pathway through development and can configure solutions that allow them to leverage CRO infrastructure and technological systems, fill gaps in technology or expertise, and tap into the CRO’s wider network while maintaining strong relationships with sites and patients.

There is already a wide variety of outsourcing models in use across therapeutic areas, departments, trial phases and geographical locations. As sponsor needs change, blended outsourcing can accommodate the deployment of different models, or versions of models, across the CRO-sponsor partnership to support sponsor objectives.

How can pharma make the most of blended models?

A blended approach places additional emphasis on partnership and cultural alignment to operate effectively. Successful implementation requires strategic alignment, strong governance, structured change management and transparent accountability with buy-in from all levels of the partnership. Before implementing blended models, it is important to assess their suitability and the sponsor’s organisational readiness for mixed-model implementation.

With the right partner in place to deliver best-fit solutions, custom models can optimise programme or enterprise-level operations for sponsors. Strategic implementation of blended outsourcing provides the accountability, control, agility, and time and cost-efficiency that are paramount to improving returns on development investment and overall success. 

For further information, visit:
ICONplc.com/blended

About the author

Tony Southers, Executive Vice President, Head of ICON Strategic Solutions
Tony Southers is Executive Vice President, Head of ICON Strategic Solutions. Mr Southers joined ICON in 2019 and serves as Head of ICON Strategic Solutions, responsible for all ICON Strategic Solutions (ISS) account operations and P&L. With over 35 years’ industry experience, prior to ICON, he worked for seven years within pharmaceutical research and development at GSK, within respiratory drug development.