Strategic Partnership

Forging a sponsor/CRO relationship that will last—and that will benefit both parties—requires up-front planning, open communication, and feedback.

Medpace's model for success has five key components, and these core elements have evolved over time and strengthened its partnership with sponsors.

Five-step model

Define expectations regarding the quality of deliverables.

The sponsor and CRO should jointly identify key aspects of the relationship. This should include the qualifications and minimal training requirements of the CRO personnel and the SOPs that will be used to run the study. It describes quality management plans and it defines the study plans, including the communication plan, the recruitment and retention plan, risk mitigation plans, and other strategic documents used to manage the program. It defines the expectations regarding audit readiness on the site and CRO level.

Define governance details.

Define the purpose of the alliance and outline the expectations for each committee involved in the governance relationship and key performance indicators and metrics that are going to be measured.

Outline a multi-tiered oversight and management structure. There are often three levels of support:

• The program management team is usually made up of the project/clinical trial managers at the sponsor and CRO organizations.

• The oversight committee represents all the functional areas that may be involved in the project.

• The executive committee encompasses the VP/CEO-levels which shares strategic direction, pipelines, and prepares to move the alliance forward.

Generate periodic summary reports.

Summarize the key milestones that have been achieved, upcoming deliverables, and the risks that are inherent in the program at that point in time. This is not a litany of the risks that have been observed throughout the course of the project, but those that are intractable or particularly critical, and they are ranked by the detail of their severity or urgency.

Report on financial metrics.

Can include standardized quarterly reporting, task-based revenue accrual, and can give an indication of pass-through and escrow costs incurred versus what was budgeted up to that point in time, detailed invoicing history, and a listing of change in scopes as they have occurred by project and across the program.

Measure success.

Key performance indicators should be defined so that the success of the collaborative team can be measured. As examples, consider:

• Measuring findings from process audits or CRO audits, and how quickly the issues are resolved.

• What kind of protocol deviations the sites are encountering? How frequent they are encountered? How they are being managed? How quickly sites are coming back into compliance.

• Clinical milestones to measure what was contracted versus what you actually achieved.

Most important benefits for a sponsor when entering into a strategic partnership

• Minimizes the time and costs associated with identifying a CRO and negotiating the outsourcing contracting process.

• Increases the visibility of the sponsor and the program within the CRO.

• Streamlines communication and escalation pathways within both organizations.

• Both organizations benefit from senior level medical, scientific, and operational oversight.

Partnership success story

Other benefits include developing mutually agreeable processes and applying lessons learned from previous collaborations. Once a relationship is established, both organizations better understand the preferred method of handling certain situations and how the CRO can best operate within the sponsor's team structure. Lessons learned can be applied to other projects in the program which eliminates some of the inefficiencies that might be inherent each time a relationship is started with a new CRO. In conclusion, developing a strong sponsor/CRO relationship requires time, commitment, planning, and expertise. For this up-front investment, the rewards are many.

Debbie Elliott, PhD, is Senior Director of Clinical Operations at Medpace, 5375 Medpace Way, Cincinnati, OH.