Sponsors and Service Providers Share Their Experiences

Each year The Avoca Group surveys industry executives and managers to understand trends in the outsourcing of clinical research. Over the years leading up to 2012, a trend was identified whereby sponsors' outsourced clinical development work was being increasingly consolidated within strategic partnerships, but there had been no industry-wide study of the outcomes of these partnerships and of the approaches that contributed most to their successful implementation. Therefore, for Avoca's "2012 Industry Survey," sponsors and service providers were asked to share their experiences regarding:

• Prevalence, characteristics, and maturity of existing strategic partnerships

• Objectives for strategic partnerships

• Satisfaction with outcomes, both overall and with respect to specific objectives

• Tools and practices used in implementing and managing strategic partnerships

• Prevalence and impact of risk sharing

• Needs, issues, and best practices

In the survey, a strategic partnership was defined as "a long-term contractual commitment between two organizations that seeks to achieve specific business objectives by maximizing the effectiveness of each participant's resources. Strategic partnerships are generally characterized by process alignment, and by risk-sharing or other provisions serving to align business objectives."

Methods and respondents

Parallel web-based surveys were created for each of sponsor and clinical service provider respondents. For each survey, respondents were asked to select the one strategic partnership with which they had the most direct experience (if any), and to report about that relationship specifically. Responses were collected over a two-month period in late 2011 and early 2012. A total of 244 usable surveys were completed: 147 sponsor surveys from 89 companies, and 97 service provider surveys from 84 companies.

Results

Sponsor perspective on the success of strategic partnerships. Of the sponsor companies surveyed, 47% had had strategic partnerships with clinical service providers. The most common objectives for launching these partnerships included reduced costs, improved quality, improved efficiency in use of internal staff, access to operational expertise, and process improvement. Among sponsor respondents whose relationships spanned a period of greater than three years, there was considerable variability in whether expectations in each of these areas were met, and in the time it took. For example:

• Reduced costs: slightly over half of respondents achieved cost savings in one year or less; almost a quarter reported never achieving cost savings.

• Improved quality: 54% of respondents achieved improved quality within one year; 21% reported never achieving this.

• Improved efficiency: less than half of the respondents felt that a reduction in effort for oversight was achieved within one year; 28% said that it was never achieved.

• Process improvement: 36% saw process improvement within one year, and an additional 40% within one or two years. Almost a quarter reported that expectations in this area were never met.

Twenty-two percent of sponsor companies reported having discontinued strategic relationships. Although a few were discontinued due a reduction in the number of partners required to support the work, partnerships were most commonly discontinued because of poor quality of deliverables, followed by poor overall performance of the clinical service provider.

Clinical service provider perspective on the success of strategic partnerships. Of the clinical service provider companies surveyed, 67% had had strategic partnerships with sponsors. The most common objectives for launching these strategic partnerships included increased business stability/continuity, improved efficiency in the use of staff, increased profit, access to more interesting projects, and meeting needs/desires of current customers. Among clinical service provider respondents whose relationships spanned a period of more than three years, there was considerable variability in whether expectations in each of these areas were met, and in the time it took. For example:

• Increased business stability/continuity: 60% achieved this in one year or less; 32% said that it took between one and two years.

• Improved efficiency in the use of staff: 52% of respondents achieved improved efficiency within one year; 32% said that it took between one and two years.

• Increased profit: 52% of respondents reported increased profitability within one year; 28% said it took between one and two years; 16% reported that it took longer than two years; and a small percentage indicated that this was never achieved.

• Access to more interesting projects: slightly over half of the respondents reported access to more interesting projects within one year; 16% said that this was never achieved.

Sponsor and provider perspectives: implementation of strategic partnerships. Both sponsors and clinical service providers reported using a wide variety of tools for, and approaches to, implementing their strategic partnerships. The tools most commonly used included roles and responsibilities checklists, written project charters, joint steering and operating committees, formal communication plans regarding the new model, and training programs for the new model. All of these tools and approaches were felt by most respondents to be at least somewhat helpful; joint committees (operating, steering, and quality) and roles and responsibilities checklists were most likely to be considered "very helpful."

When respondents were asked to describe what went well in implementing their relationships, they most commonly mentioned open and frequent communication and collaboration (including face-to-face), strong senior management support, and the establishment of clear expectations, often through written documents and training programs. Conversely, when asked to describe what they would have done differently, respondents most commonly mentioned failures in these areas.

Discussion

Based on both the data collected and consultants' experience, the survey found the strategic partnership model to be sound. However, the ability for a partnership to meet what are often high expectations for cost savings, process improvement, operational excellence, and the quality of deliverables is dependent on the foundation that is established.

The specific approaches taken by sponsors in launching their strategic partnerships have tremendous impact. The specifics of successful approaches may vary based on the outsourcing model, the sponsors' objectives, and corporate cultures, and for this reason, there is no one-size-fits-all approach that ensures success. However, best practices that appear to be common among successful partnerships have emerged. These include:

Clarity in the strategic and operational framework. This includes the objectives of, and vision for, the partnership, and the development of management practices, including a governance structure.

Documentation. Typically includes detailed guidelines for operational teams that outline the specifics of how and by whom the relationship should be managed, as well as partnership-level quality and other agreements that provide clear expectations for operational activities and deliverables.

Communication plan. Should detail processes for discussing performance expectations with partners, for ensuring continuous bidirectional feedback, and for escalation of issues through the governance structure.

Measurement. Robust systems for measuring both provider performance and relationship health are critical. Particularly important are metrics that reflect status in an ongoing manner.

Change management. Can be helpful in implementing new outsourcing models and partnerships; this includes engagement of staff as part of the process, and formal training plans.

Robust senior level support. Consistency in vision among senior management, and active support of the partnerships, are essential.

—Denise Calaprice-Whitty, PhD, Executive Director at The AVOCA Group