A true strategic partnership has benefits for both the sponsor and the contract research organization (CRO). The partnership is grounded in working together towards a common goal, and for both the sponsor and the CRO the success of one is the success of the other—with processes and talent evolving on both sides to produce enhanced clinical outcomes.
Such a partnership is very effective. It also takes a lot of work. It is an intimate, long-term relationship—and must be a two-way street, with both sides being equally invested not only in the immediate project, but in the partnership itself. Regardless of whether the teams work on every project together, they are in an ongoing dialogue about advancing their affiliation and jointly developing their organizations.
The result: Higher-quality work. Greater efficiencies. Cost savings. Commitment. And increased satisfaction for both the sponsor and the CRO.
Being a Partner, Not a Vendor
A more traditional sponsor-CRO relationship—even a preferred partnership—is largely a financial transaction. The CRO provides manpower, executing orders on behalf of the sponsor, no questions asked—and with little stake or interest in the ultimate success of the endeavor. A true strategic partnership takes the sponsor-CRO relationship up a notch. Partners work hand in glove towards a mutual goal, both fighting for success at every stage. That means working collaboratively, investing sufficient time in joint planning, being proactive, not reactive, and—possibly above all—working towards shared goals.
Different Sponsors, Different Needs, Same Desires
Just as sponsor companies come in different sizes, so do their needs—and the services a CRO needs to provide. Smaller companies may need support related to budgeting and planning, raising capital—even guidance on overall costs to understand how much funding they will need. Small companies certainly require regulatory support, and may need additional infrastructure and expertise. Often mid-sized companies have many of these same needs; with fewer resources in-house, they may look to the CRO for expertise as well as manpower.
Conversely, large pharmaceutical companies may have highly defined processes already in place. They focus on pricing, and really use CROs as outsourced labor. They tend to be disinterested in the CRO’s opinions about their product or protocol—it’s a very different need, driven by outsourcing process, outsourcing people, instead of the operations people being involved in the process of choice.
Yet regardless of size, sponsors ultimately all want the same thing: Excellent delivery, meaningful, high-touch service—and tailored support that is flexible enough to iterate as the sponsor’s plan iterates.
Only a strategic partner can deliver that level of support.
The DNA of a Strong Strategic Partnership
The fundamental components of a strong strategic partnership seem simple and straightforward: Open dialog, team continuity, realistic goals, joint responsibility, leadership engagement, and risk sharing. While these metrics are not common in most vendor-client relationships, as evidenced by the rarity of true strategic partnerships, once established as clear mutual goals they are not only attainable but potentially transformative.
1. A strategic partnership starts with true, bi-directional dialog. In our global work culture, where offices are spread around the world, we rely heavily on email, reports, directives. Yet much can be lost in translation, and, worse, critical messages get buried in peoples’ in-boxes—which can have serious repercussions. Instead, strategic partners must engage in frequent, regular, ongoing verbal conversations. These enable the CRO to:
- Understand the sponsor’s needs and drivers. The CRO needs to know more than the stated goal of the current engagement; they need to know what keeps the sponsor up at night—and then use that insight to proactively address concerns, head off issues, deliver success.
- Challenge the sponsor’s plan. The CRO can and should share advice based on their lived experience, especially if they have applicable experience from other similar studies. The words “Have you considered…?” can help avoid missteps, saving time and money and potentially changing the outcome of a trial.
- Ensure nothing falls through the cracks. The sponsor may assume that the CRO knows about a contract in France, but no one actually told the project manager. If the sponsor and CRO are talking every day, these details are more likely to be surfaced and addressed in real time.
- Plan staffing appropriately to ensure continuity. Sponsors may assume that their go-to CRO team will be available for any upcoming work—but CROs need to staff appropriately to meet their margins, and so may have alternate plans for the team when the current assignment ends. In order to have the team available for a large planned project, the CRO needs visibility into the sponsor’s future roadmap.
- Recognize the personalities and the culture of the company. With direct personal communication, a CRO can get to know the sponsor’s team: Who wants lots of back-up, who just wants the facts, and who is the strongest influencer. All this insight enables the CRO to better deliver that excellent, meaningful, high-touch service by meeting the needs of each internal customer.
With open, ongoing dialog, the sponsor and CRO can create a fit-for-purpose roadmap, iterate it as needed, and arrive at their shared goal.
2. A strategic partnership blossoms due to continuity and continuous learning. While it is important for the CRO staff to have drug-development expertise—so they don’t just check boxes, but truly understand how the process ties together from pre-clinical studies to pull-through—it is just as important that they understand the sponsor’s business.
In a long-standing strategic partnership, the CRO team moves from study to study, bringing with them invaluable knowledge and insights about the sponsor corporation, the drug, and the industry segment. Indeed, it is not unheard of for the CRO team to be so embedded that it is they who help orient new sponsor staff.
When sponsors bounce around from CRO to CRO they lose the opportunity to have that deep understanding of their organization—and the efficiencies such understanding inevitably brings.
3. A strategic partnership generates clear expectations and realistic goals. Sponsor-CRO engagements often founder because each is working from a different set of expectations. The sponsor may want a faster timeline than is realistic; there may be a lack of clarity around roles and responsibilities; worse, the feasibility may be flawed, leading to site performance failure—and the project floundering.
A strategic approach avoids these challenges because the two sides are in continual dialog and jointly form the project plan, taking sufficient time to vet strategies and prospects, each bringing their expertise to bear. The result is a plan that is well thought out, clear, and, above all, executable, eliminating the danger of missed milestones and the resultant embarrassment.
4. A strategic partnership requires mutual effort, transparency, and trust. Both the sponsor and the CRO must take responsibility for reaching their mutual goal. Each has a role to play, and the success of one relies on the efficacy of the other. If the CRO is failing at something, it may actually be because the sponsor neglected some aspect of the project, and vice versa. Yet the answer never lies in finger-pointing. It lies in openly and honestly recognizing when the project is in trouble, and what can be done by both parties to work through the issue. Throughout, both sponsors and CROs should conduct self-assessments, asking: What are we doing well and what aren’t we doing well?
5. A strategic partnership has the support and engagement of top management. Whether it is operations-level management or members of the C-suite, having senior leadership from both the sponsor and the CRO actively engaged in the project and the relationship can make a critical difference. Not only are key decisions made and challenges overcome more quickly, such engagement fosters a “one team” environment that can empower other team members.
6. A strategic partnership involves risk sharing. If both parties are truly working towards a common goal, following a timeline and plan that was developed together and mutually agreed upon, then a risk-sharing arrangement can be beneficial to both parties. If the CRO is not hitting targets, then the sponsor isn’t paying for failure—but if the CRO is delivering ahead of schedule, the sponsor may be able to submit their dossier earlier, creating financial benefit for both parties.
The Ultimate Benefit: Enhanced Clinical Outcomes
Ultimately, a strategic partnership should enhance clinical outcomes. The open communication and tight collaboration that are hallmarks of a strategic partnership can lead to a project plan that has a greater chance of success from the start, taking advantage of opportunities and forestalling issues as both sides work towards a mutually understood and mutually beneficial goal.