Critical Steps Towards a Collaborative Partnership and Governance Model

When crucial clinical trial activities are delegated by a sponsor to their vendor, the sponsor must take measures to ensure the vendor or subcontractor is delivering the agreed-upon services. This is effective vendor management in clinical trials, requiring careful selection and review of the vendor’s qualifications. Of importance is the sponsor’s continuous oversight of the vendor’s performance because the sponsor is still responsible for their clinical trial outcomes and outsourced activities. Utilizing strategies to build and develop successful sponsor-vendor partnerships was a key topic at the recent SCOPE summit. During one session, a panel of industry experts provided an overview concerning creating the foundation of a governance model and establishing partnerships to drive clinical performance. 

But what does it mean to form a partnership? A partnership is an established relationship involving close cooperation between parties that have specified joint rights and responsibilities. There are steps the sponsor can take to build a successful relationship and establish a strategic partnership with the vendor from the onset. It starts with setting intentions to establish a long-term relationship.  

Step 1: Determine Your Strategic Pathway – The Scope 

The panel presented various perspectives regarding how to build a partnership, including insights from procurement, the sponsor, and the vendor. To follow are highlights from the panel’s discussion. 

The speakers included Gary Ellsworth, VP & Head IQVIA; Stacey Limauro, Executive Director, Clinical Operations, Deciphera Pharmaceuticals; Rene Stephens, Managing Director & CBO, Danforth Advisors; and Jodi Coughlin, Director, Vendor Relationship Management, Deciphera Pharmaceuticals. 

As a sponsor, it is essential to establish the goal of collaborating with a vendor and the desired outcome. To arrive at that goal, take a close look at your business needs and the outcomes desired. Each goal will vary by company based on the sponsor’s planned study activities and the risk associated with each outsourced activity.  

Step 2: Evolution of the Partnership – Choosing the Right Partner 

The sponsor must carefully evaluate the potential partner before a partnership is established, ensuring there are no significant differences among each company that could lead to conflict. The following criteria and questions were presented during the panel discussion to consider when choosing the right vendor partner. 

Define your Business Needs and Goals  

• What is your mission?  
• Can the vendor assist your organization in moving towards this pathway?  
• Will the vendor be able to support you in achieving your long-term goals? 

Evaluate the Culture of the Vendor 

• Does the vendor’s culture align with your values?  
• Alignment on values promotes a sense of shared purpose and ethical standards 
• Many partnerships fail because they are not culturally aligned 

Identify Key Stakeholders  

• Explore the Leadership. Have you and the vendor worked together previously? 
• Are the functions and stakeholders aligned to the strategy? 
• Evaluate the Vendor’s Expertise and Experience  
• Does the vendor maintain the clinical expertise needed in the therapeutic area you are working in? 
• What is the vendor’s regulatory experience? Do they have a global footprint? 
• What are their technology solutions? Assess the vendor’s security and data privacy measures 

Step 3: Management and Governance 

There are many benefits for establishing a strategic partnership, but an investment of time and resources from both the sponsor and the vendor are necessary to maximize the outcome. Here are five suggestions to maximize the partnership from the beginning. 

Both Sides Need to Commit to a Model and Partnership 

• Determine the right roles when developing a plan to encourage partnership, teamwork, and collaboration 
• Establish the partnership by combining the cultural and operational aspects; agreeing on the contract 
• Ensure the necessary standard operating procedures are in place, including a vendor management plan 

Interview Key Executives from Both Organizations 

• This will assist in creating the partnership when key stakeholders are identified and involved in the process 

Schedule a Partnership Kick-Off Meeting 

• The kick-off meeting orients the team to the work and determines how everyone will work together, creating necessary alignment from the beginning  

Prioritize Teambuilding  

• Meet on a regular cadence 
• Face to face meetings improve communication, collaboration, and creativity 
• During meetings, discuss what is going well, what processes need to be put in place, and escalate any issues or concerns 

Maintain Enthusiasm 

• There are times when a “partnership refresh” is essential 
• Review the charter, team members, and roles and responsibilities when needed 
• Assess if there a need to change or rotate some of the team members 

Step 4: Remember, Performance Matters 

Vendor management in clinical trials is critical to ensuring a sponsor’s business requirements are being met while reducing costs and minimizing risks. Forming minimum standards for selection and management of vendors and implementing best practices is key to establishing a thorough approach to vendor management and leading to a successful vendor relationship journey. 

Halloran has helped many clients with selecting, qualifying, and developing oversight plans for vendors. Halloran utilizes their team’s extensive industry knowledge and experience to ensure an objective evaluation considering any mitigating risks you may encounter to land at an optimal project outcome. 

To learn more about vendor management in clinical trials, contact us.