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  • Clinical Trial Acceleration

Andy Townsend of Syneos Health shares his insights from the SCOPE 2017

February 1, 2017
Article

By Andy Townshend

Positive clinical research sponsor-vendor partnerships.

Across the industry, there are a number of study sponsor-vendor partnership models in play, from using a single strategy to a combination of strategies (e.g., functional service provider (FSP) or a full service clinical partnership). And while there are a growing number of CRO “partnerships,” there is no standard definition; so, a company that works with a few niche CROs may refer to those relationships as strategic partnerships.

Within these operating models, alignment to corporate strategy and the actual engagement model with the CRO make a difference. There is a need to consider what degrees of freedom will be given to a CRO based on the corporate objective. For example, does enabling a CRO to select sites increase the ability to hit key milestones if the objective is speed of development? For many, the underlying theme is that the following factors will allow CROs to drive speed and cost advantages:

  • Greater degree of freedom to utilize CRO SOPs, systems and processes
  • Greater latitude to make operational decisions, such as resource allocation and management, site identification, and selection where a CRO is capable of doing so
  • Lesser clinical trial sponsor involvement in the management of the overall progress

Partnerships are being looked at as a way to create increased value in select areas of clinical development, but there is no single best way. The most successful alliances are clearly defined with a very specific value proposition in mind. These strategic relationships can be functional in nature, product- or portfolio-driven, or at specific stages of the product life cycle. In general, we find that customers who establish strategic relationships earlier in the clinical development process foster greater collaboration with select investigators, specialty laboratories and technology providers. Establishing expectations during the early planning stages allows for the right resources, processes and effective technologies to be in place when called upon. The challenge is how to institutionalize a partnership to ensure consistent optimum delivery.

The key to any successful relationship is based on frequent and clear communication, adaptability and predictable results. To achieve successful partnerships, CROs need to invest in, and drive toward, a discipline-based model that will allow for sustainability. The road map to success in a partnership will vary from customer to customer, but the fundamental components remain the same:

  • Strategic importance – Joint commitment from the top of the organizations, with well-defined and understood objectives. Sounds simple enough, but it is often not carried out consistently.
  • Mission and structure – Investment in time and resources to set up and maintain the relationship over time. One of the most important elements of a governance structure is to set the tone for a collaborative relationship where both organizations are helping each other to achieve their respective goals.
  • Life cycle, tools and standard operating procedures (SOPs) – Tools such as operations manuals, key performance indicators/dashboards, quality agreements, responsibility matrices (RACIs) and charters reflecting delegation of authority are all tools designed to enable the relationship to grow and mature over time. In order to maximize the value of an alliance, customers need to enable the CRO to do what they do best with a minimal level of complementary oversight to ensure verification of quality deliverables and compliance. Additionally, the use of incentives can play an important role in encouraging the right behaviors and predictable outcomes. Incentives should not be used to penalize performance issues; however, CROs must be willing to invest in the relationship to demonstrate their ongoing commitment. Needs will vary based on where the partnership is in the life cycle of the relationship.
  • Culture and reputation – Cultural fit and reputation are critical elements of a successful clinical research collaboration. Ensuring a culture of trust, collaboration and transparency requires feedback and recognition loops across the customer organization. This will ensure that staff assigned to projects are fully engaged and performing at a high level. As we know, unexpected things happen in all clinical trials, but how effectively an alliance responds to the challenge or element of change is a key success factor.

It is not uncommon to find that the commercial models used for the various outsourcing models do not align with the objectives. For example, many companies focus on significant price reductions through rates or discounts but do not align to the corporate objective, which could be primarily focused on quality or speed of development. The financial model needs to be attractive to both parties and the key features/mechanisms should be in the spirit of driving a partnership and driving unique value.

About the Author

Andy Townshend is Senior Vice President, Alliance Development at Syneos Health™. He is responsible for developing strategic accounts within the pharmaceutical and biotechnology industries. This includes a responsibility for the top 20 pharmaceutical companies and focuses on novel and innovative engagement and alliance models. Prior to this, Townshend was Vice President and Worldwide Head of Outsourcing for Pfizer. In this role, he was responsible for development of outsourcing strategy, development contracting and budgeting with $1 billion outsourcing spend. Townshend has held a number of positions in outsourcing for Research and Development and Commercial Divisions, both in the U.K. and U.S., and has led numerous global sourcing initiatives. He previously spent more than five years in various business development roles at Covance.

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