Sponsor/CRO Partnerships: The Secrets of Happy Couples

June 16, 2016

By Angela Woodall, Healthcare and Environmental Reporter.

Contract research organizations started out in the 1980s handling small back-burner jobs for corporations engaged in the development of new drugs and medical devices. Now they are involved in nearly every phase of getting a product — from the earliest stage of a clinical trial through the regulatory process.

Not surprisingly, the changing roles that contract organizations play in the development process have been accompanied by new expectations of CROs and the companies hiring them.

Sponsors, mainly pharmaceutical and biotech firms, are looking for financial stability and a track record of success in an outsourcing partner. In other words, they want quality and reliability in a partner. For their part, CROs want to work with a company that sets clear goals and expectations and has enough trust to let it do its job.

The two worlds might seem like they have nothing to do with each other, but they aren’t so different when it comes to making a relationship successful. As one survey of CROs put it, “Working together is like a marriage. It seems simple but is a lot of hard work.”

Unfortunately, the two sides are not always finding what they want in a partner. With that in mind, here are some pointers from experts in the world of romantic relationships to help contract research organizations and the companies hiring them find the right match.

“You Complete Me”

Sometimes opposites attract. But they don’t necessarily make for a compatible relationship, according to Theresa DiDonato, a social psychologist who studies romantic attraction and satisfaction at Loyola University Maryland. She recommended that couples gauge their compatibility by asking questions like, “Do we have similar health habits?” and “Am I thinking of someone else?”

No one is perfect but together the strengths and weaknesses of two people (or outsourcing partners) can complement each other to make a great team. It’s like when Tom Cruise tells Renee Zellweger in the film Jerry Maguire: “You complete me.”

Chris Rull, who manages outsourcing relationships for Merck Serono, takes a similar approach. He advises sponsors to ask similar questions in order to define their own strengths and weaknesses up front. Then the company can ask what they really need from a CRO in order to run a successful clinical trial based on the project and the organization. Enrollment Improved for Phase III Clinical Study.

Power and Trust

Compatibility is important but effective communication can make or break a relationship. In fact, PROJECT SMART, which helps executives manage outsourcing partnerships, recommends thinking about communication as a project deliverable. However, some topics are hard to talk about and often lead to arguments instead of marital bliss. Of those power and control stand out, according to Victor William Harris, a contributor to the University of Florida’s Happy Relationships and Marriages series. “Indeed,” he wrote, “control and power issues are the foundation of most conflicts.”

Unfortunately the same is true of CROs and sponsors, according to a survey by SCORR Marketing and CenterWatch, which provides information about clinical trials. The power dynamic played out in several ways. For one, CROs ranked sponsors low (2.86 out of 5 possible points) on setting realistic project timelines. However, the contract organizations were not letting sponsors know that they thought the expectations were unrealistic, setting both parties up for conflict. The takeaway: “CROs have to say no to sponsors when expectations are unclear or unrealistic.”

Sponsors scored better on being open to collaboration (3.44); treating the CRO as a valuable partner in the study process (3.32); and being open to innovative suggestions by the CRO (3.28). Interestingly, being open to change was one of the most important but underrated elements in a successful relationship identified by Rull, who says that, “Both parties need to be willing to invest, change and evolve with the partnership and make use of the expertise and experience that each bring.”

Flexibility

Investing in change takes trust and flexibility. The authors of “Outsourcing, the challenge of science, speed and quality” say that the ideal outsourcing partner can adapt to the variable demands of clients as well as the different stages of a process in a project.

That means looking for CROs with the relevant expertise that will allow them to support clients and satisfy regulatory agencies. Companies large and small appreciate good science combined with high speed but not at the expense of quality, according to the authors, Simone Adler-Burzlaff, Jason Bertola and Roger Marti. “What holds all three components together in the outsourcing process is an efficient project management system that not only allows for modification from the supplier side but also simplifies and expedites communication from clients.”

Commitment

The more experience a CRO has with a sponsor, the better the relationship, respondents in the SCORR-CenterWatch survey also reported. Longevity has its advantages but is hard work, requiring a combination of flexibility, trust and communication. Commitment is also key to success. However, the commitment has to be real and not just the result of a temporary infatuation.

Most successful couples stay together because when they say “I do,” they believe the marriage will last. That is what Cornell University Professor Karl Pillemer found from interviewing 700 older Americans. “There’s a spirit of initiative to overcome problems,” Pillemer wrote.

Fortunately, CROs and sponsors won’t have to worry about staying together quite so long as Pillemer’s couples. But the advice from this 88-year old about his marriage still applies: “We have had some pretty hard arguments, believe me. You’ve got to deal with it and not to have in the back of your head that you’re going to split.”

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