Yes, investigator relationship management (IRM) efforts are sweeping through pharmaceutical companies’ headquarters these days, causing all manner of meetings over how to make clinical investigators happy and keep them bringing in quality data.
But what of the contract research organization (CRO)? How does it fit into this equation? Because if sponsors and investigators are getting chummy and tight through these new IRM initiatives (better communication, better training, quicker payment) doesn’t that, by definition, squeeze out the CRO? After all, three’s a crowd.
Absolutely not, said Jane Eisner, senior vice president of global access to patients services for Quintiles Transnational, the world’s largest CRO.
In Eisner’s estimation, CROs must fit into the equation by doing much the same thing that sponsors are, but perhaps a bit better. Or at least differently.
While sponsors like Wyeth, Eli Lilly and Sanofi Aventis are instituting wholesale measures like reducing the number of contact people or streamlining payment mechanisms, Quintiles is taking a much more site-specific approach.
“We are taking a look at what the challenges are for individual investigators and seeing how we as a CRO can help them,” said Eisner. “We do it on a case-by-case basis, working with them, understanding their needs.”
Need A Nurse?
For example, if a site is having a tough time pulling pertinent data out of, say, a new electronic medical records system, Quintiles may hire a data mining expert for them. If a site is overwhelmed with scheduling patient visits, Quintiles might provide a nurse to help with that, said Eisner. Ditto if specific training is needed, or help surmounting regulatory hurdles.
Eisner added that Quintiles works with about 10,000 investigators each year. Though many big pharma companies are just beginning their IRM thrust this year, Research Triangle Park, N.C.-based Quintiles has been at it for four years.
Said Eisner, “The number of principal investigators has declined year over year. Fifty percent of physicians who participate in a trial choose not to participate again. We had to do something.”
The Opposite of Weeding
And so the company launched its global partners program, which now has several hundred employees focusing on not only keeping established investigators around but drawing new ones into the fold.
This is in contrast to what many sponsors are doing as part of their IRM efforts: weeding out sites with a less-than-stellar performance in favor of focusing on classically high-performing sites.
Come On In!
How is Quintiles going about it? Eisner explained that the global partners team now approaches trial-naive physicians offices asking if they are interested in working for industry. If the answer is yes, Quintiles staff members scrutinize the potential site. Can they make the commitment? Do they have enough staff? If so, Quintiles trains and pulls them up to speed on what they need to conduct studies, eventually adding new investigators to their stable well in advance of a trial.
“This takes a long time,” said Eisner. “These relationships have to be built over a long period.”
One Person Only
Once the sites have signed up with Quintiles, they are assigned one point person through which they express their needs. Eisner said this contact person—their “relationship manager”—stays with them throughout trials as well.
This is similar to what large sponsors are starting to provide for sites, which have long cried out for a reduction in the number of people at a sponsor who must be contacted during a trial.
Need Pharma? Not Really.
But what about talking to the sponsors? Don’t these IRM efforts by big pharma presuppose that sites want a direct relationship with the sponsors—not a middle man?
Not really, says Eisner. “When you look at some of the survey results, the investigator sites understand what the role of the CRO is, and it’s not like they have this preference that they must have a huge interface with pharma.”
And yet, said Eisner, if a particular site expresses a desire to connect directly with the sponsor, Quintiles will arrange that. Whatever makes the site happy and functional.
Fix The Money
Like many sponsors deep into their IRM efforts, Quintiles is working on improving payment mechanisms this year.
“We’re looking to see if there are ways to streamline and bring the payment schedule down, because that’s very important,” Eisner said.
EDC Nearly Complete
She added that moving more sites to electronic data capture (EDC) systems, instead of paper, will help that along. EDC has been in effect at many of the sites for upwards of a decade, but a critical mass of them have gotten on board more recently. It also helps that many sponsors are now adopting EDC, she said.
Like most sponsors, Eisner says Quintiles’ efforts with sites will be ongoing, with the assumption that you can never do enough to make a site more happy or healthy.
—by Suz Redfearnd9A2t49mkex