How do biopharma companies choose the right CROs to run their clinical studies? What do sponsors need to do to ensure a smooth collaboration? Do they care about oversight? Through this brief summary of some presentations made by biopharma executives at this year’s Drug Development Forum, we offer some practical advice for sponsors on how to manage a smooth outsourcing relationship, and, for CROs, a peek into sponsors’ decision-making processes.
When choosing the best CRO partner, of course the size, phase and therapeutic area of the study matter, but Shannon Devens, executive director of clinical operations at Surface Oncology, a 2015 Fierce 15 winner, said her company also wants such relationships to be a match culturally. And to determine that, Devens said she prefers to conduct kickoff meetings face to face.
“You can see how your team interacts … figuring that out at the kickoff is a lot better than when you’re down the road and you introduce them to your sites,” she said.
But Karen Gardner, senior director of clinical development operations at CSL’s vaccines subsidiary Seqirus, said face-to-face meetings aren’t always possible. In those cases, it’s important for sponsors to know what they want and to ask lots of questions, she said.
Buying a multidimensional service
To Gardner, entering into an outsourcing partnership is buying a multidimensional service. “It’s a component of people, of process and of work that needs to be done and when,” Gardner said.
Gardner raised the difference between smaller biotechs, where one executive might be responsible for many aspects of the business, and big pharmas, where each person has more defined responsibilities.
She said a sponsor needs to understand what it wants from a CRO and how it wants to interact with them as well, and “that also does determine about the choice of the CRO, to know that they have the flexibility to work in the style and the structure of your company.”
It might be especially difficult for small companies to get the full attention from big CROs—or small CROs from big biopharma businesses—but Tokai CEO Jodie Morrison said the CEO-CEO relationship or any C-Suite-level connection when picking vendors is critical. “As a small company, you tend to have a series of vendors that are critical to the success of the company; you don’t have those in house,” she said.
Morrison said that she found an existing peer-to-peer relationship at the beginning makes discussions easier “because people know you have that relationship at the top, so, if they ask what things are up, it’s going to get back in either direction, so, people tend to keep it at the appropriate level better.”
A true budget
Cost does matter when it comes to selecting a CRO, and it’s not always the cheapest that matters, it’s the realistic cost, Gardner said.
“At the RFP stage, certainly the second time around … we certainly look at did they deliver to the milestones, what was the quality they delivered to, and did they deliver to the cup scope creep (uncontrolled growth),” she said. “Because I like to know that the deliverable or the budget that came in the first place was a true budget.
Don’t make presumptions
In Gardner’s opinion, it all comes down to being transparent with one another about shared accountabilities and missions, and communications matter in having the right processes in place.
“It’s so easy to be ambiguous because it’s hard to actually define our clear roles,” she said. It seems troublesome to work out all the details and the protocol, but it’s important to lay them out clearly without making assumptions. “You’ve got key performance indicators, but what do they mean and how are you using that data?”
Gardner also raised the example of the same title entailing different responsibilities at different companies, both for CROs and sponsors. “Job titles don’t mean much, so what you need to do is really understand the details and work through those areas of defining out those accountabilities.”
Without naming any specific CRO, Gardner said her company had great experiences when both sides invested in kickoff meetings to develop out study documents before the first patient and before the investigator meetings. “Not only do you know what you’re doing, but your CRO also knows what you’re doing.”
The recent ICH GCP E6 (R2) addendum, the biggest revision of the international GCP guidelines in decades, put a lot of stress on sponsor oversight, including quality management, CRO and trial management, data and record keeping. “They (inspectors) asked the question of not just tell me how you knew your CRO was doing what they would be doing … but had to show documented evidence of how we could prove that they weren’t taking decisions that they weren’t allocated to take,” Gardner said.
This means that biopharma companies need to strike a balance between making CROs feel like being part of the same team, that “we’re in this together,” and making sure that they follow the right procedures and correcting them along the way.
Devens said to tackle that, Surface is building a team of overseers instead of doers so that it doesn’t have a redundant team that only does or redoes what the CRO has done. The company also complements that with a study oversight plan which maps out by every function where it transfers responsibilities, and shares that with the staffers.