Strategic partnerships between sponsors and CROs are an important part of today’s clinical research landscape. When managed effectively, these relationships provide customers with collaborative strategic resources that drive optimized solutions. Partnerships help ensure the continuity of project teams and operations, development of best practices for continuous learning, and streamlined resource planning and staffing. They can also provide pricing sophistication, including transparency and risk/reward models. Additionally, joint participation in planning and design improves protocols and enhances operational delivery and feasibility.
Most importantly, successful strategic partnerships lead to enhanced clinical outcomes, providing consistent quality across all projects, which reduces the volatility of timelines and budgets, and improved development strategies.
The best practices for navigating the sponsor-CRO relationship come down to setting expectations, establishing responsibilities and meshing cultures. Read on to find out how.
1. Remember to be a partner, not just a vendor.
From the very beginning, this is your chance to promote a mutually beneficial long-term relationship. To do this, start by identifying the DNA of a successful partnership: longevity, effective governance, and appropriate risk-sharing. Always value collaboration over transaction, and embrace shared goals.
2. Be ready to overcome these common challenges.
While each clinical research project is unique, certain challenges frequently crop up in sponsor-CRO partnerships. Make sure your team can effectively handle these situations:
- The lag that comes before expectations are agreed upon, the contract is executed and a mutual understanding is achieved.
- Uncertainty about responsibilities and decision authority.
- Differences in expectations, processes, personalities, corporate culture, and understanding of responsibilities.
- A lack of adequate time for the RFP process.
- Not enough planning, risk management, informative reporting, effective communication and governance structure.
3. Always avoid the four Fs.
The toxic four Fs of strategic partnerships build upon each other. If you find yourself dealing with one, resolve it ASAP before it transforms into another down the line.
But just what are these four Fs? They start with Faulty RFP process planning. Uncorrected, faulty plans lead to Flawed feasibility. When the basic processes involved in a study don’t work, you’ll see Failed site performance. And when multiple sites fail to deliver, overall project delivery Founders.
4. Tailor your approach to company size.
A CRO must appreciate the different needs of different sponsors. While many skills and policies are translatable, a broad one-size-fits-all approach doesn’t work well.
Smaller companies tend to need a full range of support when it comes to expertise and infrastructure. Newly established clients especially will require more involvement from a CRO for budgeting, planning and capital raising. Such companies will also likely need a high degree of program development guidance.
While midsize companies may have many needs in common with smaller companies, they can also be very different, especially in the bidding processes. Most midsize companies look to just-in-time bidding as well as scenario modeling instead of rebidding.
In contrast to smaller and midsize companies, large companies usually request little to no collaboration at the planning stage. They are likely to already have highly defined processes, including outsourcing. Understanding a large company’s pricing considerations and governance will also be crucial.
No matter the type of client, all strategic CRO-sponsor partnerships have a single common denominator: Each requires service that addresses their own unique needs for delivery excellence.
5. Keep the ultimate goal of the strategic partnership in mind.
A strategic partnership is a balancing act between the sponsor’s need for flexibility and the CRO’s need for standardization. However, at all times both parties need to remember that they have the same objective: bringing a quality product to market. Sharing goals goes a long way toward fostering alignment — a “one team” culture will go further than one constrained by silos and isolation.
The best strategy for cultivating this attitude is through:
- A high-touch customer service environment with a real-time operating model.
- Activities that are collaborative rather than transactional with full transparency and a data-driven core.
- Changing behavior from reactive to proactive.
- The joint pursuit of development milestones and business objectives.
All of these aspects of the strategic partnership must be maintained during design, planning, execution and close-out stages. It may sound complex, but it doesn’t have to be a difficult or expensive process — but getting it wrong will cost you.
6. Build the relationship on a foundation of these core principles.
Effective partnership implementation is founded on:
- A staff focused on drug development.
- Joint planning and staffing between organizations.
- Continuity and continuous learning to ensure that all involved stay on the same page.
- Integration driven by simple key connectivity points, which improves clinical outcomes across a wide range of activities.
- Dedicated peer-based partnership management, focused purely on partnership goals and objectives.
Successful strategic partnerships and indeed, the whole drug development process, requires commitment and expertise from both parties.