Changing the Nature of the Relationships
Several executives cite the importance of working to change old attitudes about the nature of the relationship between provider
and sponsor—attitudes found on both sides. The shift from what was once a transactional relationship into a truly collaborative
one is recognized as crucial to improved satisfaction.
"Five, 10 years ago when transactional types of contracts or relationships were in place, it was very easy to say, 'The CRO
screwed this up,' and they were replaced. When there is a strategic relationship being built, there's a lot more at stake
for both sides, and I think there tends to be a lot more effort put into the relationship when they're at this higher level,"
says Celtic Therapeutics' Babani. "Just like in real life, in order for it to work, both sides have to put in an effort."
Mitch Katz, Purdue Pharma's executive director of medical research operations, says that internal training/coaching sessions
improved how Purdue works with the CRO as a team. "Coaching is needed because people tend to revert back to the transactional
mentality as opposed to the collaborative mentality," he says. This training was extended to the CRO because the provider
also needed to have their internal teams trained to work collaboratively. Notes Katz: "Organizations have realized that the
kinds of relationships that existed with CROs years back are really different than the way they need to be now. They are realizing
that CROs are not just an extension of staff but are really a part of a development team. You're seeing that organizations
are spending more time looking at the relationships and managing them."
Early and complete integration of the CRO into the development of the program is also a critical element in making the relationship
work. The CRO must fully understand the sponsor's needs—something the executives mention as being behind their effort to improve
the clarity of expectations imparted to CRO partners. Then CROs have to try, as if they were part of the sponsor's organization,
to reach key milestones and get to the finish line on time. "That would say [to me] they were no different than my internal
team and [that] they felt a passion and commitment just as if they were my own personal employees," says Katz.
Managing the Relationships
All of the executives interviewed say that managing the way interactions between sponsors and CROs proceed is key to sustaining
successful outsourcing relationships. Blankstein sums it up: "If companies are going to outsource because they believe it
may be a more efficient use of internal resources, they'd better set up effective governance systems to manage the relationships
to ensure quality and optimal performance."
There is also broad agreement among the executives that it is critical to set up governance and oversight structures, such
as escalation pathways, to manage sponsor/CRO relationships. Part of managing the relationship involves setting up metrics
to measure performance outcomes, through key performance indicators (KPIs), as well as ways to measure "softer" relationship
outcomes (with key relationship indicators, or KRIs).
"Big Pharma is looking for more strategic and focused relationships with CROs, and that leads to better satisfaction with
CROs," says the director of clinical outsourcing at a Top 20 company that has sought to create a more robust and better-governed
relationship with the CROs. "We are also focusing on putting lots of effort into relationships and alliance management tools
and processes," the executive says. "The metrics used to manage the sponsor/CRO relationship look at both hard data, such
as financials, as well as softer relationship areas, like trust and behaviors."
Creating a well-defined governance structure with clearly defined roles, responsibilities, and core competencies really helps
companies to learn what their strengths are and how they can work as a strong team. "These structures help people to understand
roles and responsibilities, and to leverage each other's strengths and weaknesses," says Purdue's Katz. "But it also helps
to create a different, more collaborative relationship philosophy."