The Essential Elements Of A Good Sponsor/CRO Relationship

By Ed Miseta, Chief Editor, Clinical Leader

The pharma/CRO relationship can be a complicated one. Each side knows what it wants to gain from the relationship, but those goals or the route to achieve them do not always align. Having a fundamental understanding of what the other side is hoping to accomplish is critical to the relationship developing and maturing in a productive and harmonious manner.

Emily Hickey, DVM, Ph.D. and Corporate VP of InVivo Discovery at Charles River has experienced this relationship from both sides of the aisle. Prior to joining Charles River, she spent several years working in outsourcing at a large, global pharmaceutical company. Hickey notes outsourcing was not a particularly interesting option for them until just a few years ago. In her capacity in the outsourcing department, she was responsible for developing relationships with CRO partners.

"We did the world tour of CROs," she admits. "We reviewed who could do what, which areas each company excelled in, how pricing lined up, and more. Based on our findings, we made decisions on where to place much of the outsourced preclinical work. Our overriding goal was to ensure the quality of our science was maintained, whether we did the work internally or with an outside partner."

Remain Vigilant And Objective

Emily Hickey, DVM, Ph.D. and Corporate VP of InVivo Discovery, Charles River

Embracing the role of one who liaised between the internal scientists and the outside contractors was not without its challenges, and the pressures of the job came from many different sources. Still, overcoming those challenges was instrumental to maintaining the relationship. One challenge Hickey faced were the aggressive timelines of management once the decision was made to outsource. Companies need to maintain their internal expertise so as to be able to build up that external expertise. At the same time it was necessary to verify that outside expertise matched up with the internal team, especially when it came to quality.

"Management can sometimes want to move a project to a CRO before the 2 teams have adequately transferred the required knowledge and technology," she says. "In those situations, one of the hardest parts of the job can be remaining objective. There are always going to be times when you have to be an advocate for one side or the other. But trying to have everyone hold off on making that outsourcing move until both sides were ready is definitely a challenge."

She also notes some internal employees will harbor double standards when it comes to CRO partners, which can put the entire relationship at risk. The internal groups will have certain standards for how they might run a trial and handle the data. If a mistake is made, it is corrected and the study moves on. If a CRO were to make the same mistake, suddenly those same employees believe the relationship should be dissolved.  

"Things can blow up very quickly," says Hickey. "You really need to have someone at the sponsor company who can serve as the advocate for an objective approach to the relationship. They need to make sure that what you have in place is truly a partnership and not just a service provided for a fee. That was one of the biggest goals of my position. We strived to develop partnerships to the point where our internal scientists felt the external scientists were an extension of their own lab."

As part of the team that made the outsourcing decisions, there wasn't a day that went by when Hickey didn't feel her reputation was on the line. As a result, she would go to work every day 100% focused on those relationships. Her position entailed constant communication with partners and the internal teams, ensuring everyone was saying exactly what they meant, and documenting everything that was said. Those documents were then reviewed by everyone involved to verify communications were interpreted and documented correctly.

Enthusiasm And Mutual Respect Go A Long Way

Hickey notes there were oftentimes subtle and non-tangible differences between the CROs she interacted with. Some of these differences, no matter how small, would often determine whether or not she chose to work with a particular company. Enthusiasm for a project was something she took very seriously.

"Every CRO I spoke to would tell me they wanted our business," she says. "Obviously that's where they get their revenue. But there is a big difference between companies that wanted our business and those that truly wanted to partner with us. We preferred to focus on the latter. I remember several instances of sitting at the table with a CRO and explaining what we wanted to do. Some would be outright dismissive, and would basically tell us how to do things. They were essentially saying ‘this is how we do it, it's how you should do it, and we don't really care how you did it before’."

CROs at the opposite end of the spectrum would wait for the sponsor to tell them exactly what to do. That situation was also undesirable. In an ideal framework, Hickey felt a potential partner should possess the scientific knowledge and expertise in the critical areas of the study, but also be willing to discuss the best route forward in a consultative manner, treating her as an equal partner at the table.

"We might think about a protocol and come to the table with an opinion on how it should be conducted," she says. "But it would not be uncommon to meet with a CRO who has performed more studies in that area than we have. The value they can really bring to us is to note they have performed something similar five different times in five different countries, and what they were able to learn from the experiences. Sharing things that they have learned that we haven't is what makes a CRO a valuable partner.”

For example, if she sits down at a meeting and presents a particular protocol, she would want the CRO to assist her in understanding any and all options available. Have they tried it that way? What did they learn? Are there other ways they tried it? Are there other options they might recommend? Is there anything she has failed to consider? By discussing possible options in an open manner, both companies are able to learn and grow together, which is necessary for a true partnership.

Hickey has also met with CROs who, because of their experience, were able to make suggestions that resulted in large savings of both time and money. "A CRO that can, because of its experience, suggest ways to perform a study with half the personnel or in half the time is incredibly valuable to us," she adds. "That kind of knowledge and experience just adds a whole new dimension to the relationship."

Going forward, Hickey believes pharma will continue to rely on CROs to deliver much of the expertise they do not have access to internally. One current trend in the market is the movement of scientific talent from pharma companies to CROs and small biotech firms. She believes this will continue, and will help to transform many CROs into CSOs (contract scientific organizations).

"Eventually, these relationships will be about bringing scientific partners together," she states, "Pharma and its partners will be equal players at the table, helping each other get to better end points in a shorter period of time. That is what will be necessary for us to get needed medicines to patients in the most expedient and efficient manner possible."