DOCS - Functional pharma

As the pharmaceutical industry continues to move away from transactional outsourcing, functional service provider solutions are growing in popularity. Barry Balfe, vice-president of global operations at DOCS, explains how the DOCS FSP Delivery Platform can drive efficiencies across the clinical development spectrum.

Recent years have seen a dramatic shift in pharmaceutical outsourcing practices. As sponsor companies seek to cut costs, while accelerating the development of pipelines, they continue to revise their relationships with CROs. Rather than outsourcing individual studies, the trend is towards integrated partnerships, including functional resourcing or functional service provider (FSP) alliances. In these models, the CRO performs a key function - be it project management, clinical monitoring or medical affairs - across the sponsor's portfolio of trials.

"From across our customer base, we have seen significant growth in requests for functional resourcing solutions, as an alternative to traditional modes of project outsourcing," says Barry Balfe, leader of DOCS's global FSP business. "And, with over 15 years of experience in this space, we have a proven ability in the delivery of world-class resources to support our customers' requirements.

DOCS development

Having begun life as a staffing business, DOCS was acquired in 2007 by ICON, one of the world's largest CROs. Since then, its has developed into one of the drug development industry's leading FSPs, matching its resourcing heritage with ICON's clinical nous. In October 2012, recognising the growing demand of customers for FSPs, ICON announced the consolidation of FSP and resourcing services into the DOCS division.

"By marrying the core competencies of a resourcing organisation with those of a leading CRO, DOCS has become a particularly powerful player in the FSP space," says Balfe.

DOCS's journey from staffing to FSP has been largely mirrored in the market at large. Today's functional models are drawing in the gamut of clinical trial sponsors.

"Some customers simply wish to consolidate their spend with a single resourcing provider and to drive efficiencies in their vendor management strategies," says Balfe.

There are many examples of emerging biotech firms without the funding or the inclination to outsource all of their studies, but who require more than just a staffing service from their CRO partners. Rather, they are seeking to implement multiple resourcing solutions, function by function, that facilitate accelerated development of a product without necessarily building permanent infrastructure and their associated fixed costs.

Balfe also comments that,"At the other end of the spectrum, certain Big Pharma sponsors are making a strategic decision to entirely divest themselves of particular in-house drug development competencies in favour of sourcing the necessary expertise from their FSP partner."

Whatever the case, the right solution for a particular sponsor will be informed by its underlying development strategy.

"The FSP models that prosper are those founded on a clear future-state vision defined by the sponsor; whether that involves divesting core competencies, leveraging spend or managing peaks and troughs in resource demand," according to Balfe. "In many ways, the sponsor has to reconfigure its organisation to act as a host to a new entity, in order for the FSP partner to adapt to, rather than define, the sponsor's development objectives."

Fivefold FSP strategy

"Rather than outsourcing individual studies, the trend is towards integrated partnerships, including functional resourcing or functional service provider (FSP) alliances."

While acknowledging the diversity of FSP models, Balfe perceives five common factors critical to their success. "First, the partners must precisely define their relative roles and responsibilities and the risk-sharing parameters," he says. "Second, they need clearly defined escalation pathways. Third, there should be a multifunctional governance model that incorporates regional affiliates and third-party stakeholders. Fourth, FSPs require effective demand management forecasting in order to resource appropriately. And last but not least, we always emphasise the importance of including a change management forum from the inception of the alliance, as we have never seen a model that looks the same after two years as it did at the point of implementation."

Ultimately, success can be measured in terms of how well the strategy helps sponsors to meet their quality objectives. The results are clear to see. Within two years of implementing a functional model with DOCS, customers have achieved like-for-like savings in excess of 30% and productivity increases over 40%. Excellence has been achieved through resourcing excellence, repetition and rigid focus of FSP personnel on a well-defined function.

DOCS continues to differentiate itself in this growing market niche. With local knowledge and insight on the ground in over 40 countries, it develops teams with skills optimally aligned to sponsors' needs. Through its trademarked DOCS FSP Delivery Platform™, it prides itself on a seamless deployment of tailored solutions. Flexibility, quality, speed and scalability are key.

"We think FSP models need to be deployed differently to meet the needs of each customer," says Balfe. "Traditional CRO models don't always achieve that level of flexibility and traditional staffing models do not support the needs of a modern drug development organisation. We reconfigured our business to flexibly deploy these global FSP models in response to growing customer demand. We believe that the DOCS FSP Delivery Platform offers sponsors a competitive advantage in advancing the development of their pipelines."

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