Barry Balfe, vice-president of global programme management at DOCS, looks at the trend of using strategic functional service provider alliances to improve the challenges facing the pharma industry.

The pharmaceutical industry is facing numerous challenges: the patent cliff, depleting pipelines, stiffer regulatory requirements, increased demand for novel compounds that satisfy unmet medical needs, and shorter drug development timelines across the clinical drug development continuum. Pharmaceutical and biotech companies need innovative, flexible approaches to address these challenges. Because transactional outsourcing does not mitigate these risks, there is a shift towards a functional service provider (FSP) solutions model.

An overview of FSPs

FSPs are a range of discrete sourcing strategies that are defined by the alignment of CRO partners with a function of the sponsor’s business, rather than with a single study protocol.

While the design of these resourcing models varies, functional resourcing partnerships are almost invariably characterised by the same value drivers:

  • lower-cost alternatives to traditional full-service outsourcing
  • the potential for flexible capacity and optimal resource utilisation
  • CRO and sponsors require a deeper and more structured relationship
  • CROs need to cover all of the countries in which
    sponsors operate.

Tailored solutions

Each functional resourcing model has a different value profile and can be tailored to the needs of a particular sponsor, addressing their development strategy, pipeline and in-house capacity. While there are several functional resourcing models, FSP continues to grow in popularity as sponsors look for innovative outsourcing strategies that enable them to gain efficiencies and accelerate the development of their pipeline.

With an FSP, the sponsor relinquishes resources and expertise within a particular function and partners with a CRO to support this area of the business. Accordingly, the CRO partner assumes responsibility for a role across the sponsor’s entire development portfolio, for example, conducting all site management, data management or regulatory activities for all of the sponsor’s trials.

FSP models may be characterised by the use of either the sponsor’s or CRO’s systems and procedures, shared responsibility for the oversight of deliverables, programme-specific training standards, extensive cross-functional governance and jointly owned measures of success. Because of their global nature and enterprise-wide scope, FSP agreements bind both parties to long-standing and close strategic partnerships. In addition, the commitment to divest an entire function to an FSP maximises economies of scale and enables CROs to deliver the highest levels of functional efficiency.

Critical success factors for an FSP model

While FSP models are tailored to sponsor requirements, there are four factors that are critical to their success. Each of the following factors must be met for a sponsor to fully realise potential benefits in areas such as cost, quality and operational efficiency to accelerate drug development.

  • Scope: partners must define their roles and responsibilities within the partnership.
  • Escalation: escalation pathways are required to ensure that CRO and sponsor personnel know how and where to address issues for rapid resolution.
  • Governance: in order to align the different organisations and streamline decision making, there should be a multi-functional governance model that incorporates the sponsor and CRO function owners.
  • Demand management: there is a need for effective workload and resource-forecasting mechanisms. Quality, business continuity, productivity and study objectives can only be met when the partners plan effectively for the resource needs.
  • Change management: involve key team members in a forum for planning and implementing change from the very inception of the partnership to facilitate a seamless and ongoing transition process and continuous improvement.

Ultimately, success is measured in terms of how well the FSP model helps sponsors to meet their objectives. Within two years of implementing an FSP model with DOCS, clients have achieved a 30% reduction in development spend and productivity increases of up to 40%.

The DOCS FSP Delivery Platform deploys strategic solutions that combine a global resourcing engine with clinical development expertise. Clients benefit from reduced costs, improved quality, enhanced productivity and accelerated cycle times.

As part of ICON, DOCS leverages its parent company’s extensive therapeutic, geographic and functional expertise to ensure greater efficiencies across client programmes.