Filling in the Bigger Picture - Pharmaceutical Executive


Filling in the Bigger Picture

Pharmaceutical Executive

"Don't wait until the last minute to tell us bad news, when it's about to blow up," says a senior director from a pharmaceutical company. Others across the board agree with this sentiment.

"What's important is that they are forthright when issues and challenges come up or errors are made, rather than letting them go longer than they need to," says Larry Blankstein, senior director of clinical research at Genzyme. "I look for a CRO's ability to identify a problem, raise it quickly, and come up with a solution that can be implemented, and then make amends for their error and deal with the issue."

These qualities—honesty, accountability, a proactive approach, and creativity—came up repeatedly when executives were asked if they could recall any situations in which a CRO's performance really wowed them. Rather than talking about a situation in which everything proceeded without a hitch, most executives recall how CROs had faced crises, confronted and resolved them, and came out looking good.

"The CRO made a huge effort and still delivered on time despite a shortened timeline," says the director of clinical contracts at a Top 20 pharmaceutical company. "They still turned around documents and completed activities on time."

"When a problem arose during a clinical trial conducted for Genzyme, the CRO brought it to our attention and discussed what steps they would be taking to remedy the situation," Blankstein recalls. "They let it be understood that they were going to be doing additional analysis for us, at no cost to us, to ensure any impact on the study results would be understood."

Nealon cites a CRO's excellent response to concerns raised by Millennium during a global program. "We followed the escalation pathway agreed upon at the start of the study, and the CRO responded to our concerns and continued to raise the concerns with their senior management," he says. "The output was additional resources by the CRO, and some new staffers were added to the program who provided better-quality output. The fact that they listened to our concerns, responded rapidly, and the new team members are already turning the concerns around is very impressive."

Other executives mention instances when CROs went the extra mile to act like true team members, making suggestions that proactively avoided potential delays or saved the sponsor money. "Once during budget review, the CRO worked with sites at each visit and reconciled what was done versus what was invoiced—and it was their idea," says a clinical scientist at a Top 20 pharmaceutical company. "They tracked it down and saved this company money; they acted like it was their money being paid per procedure, which was really appreciated and made them stand out."


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