It started modestly three years ago. Covance asked 16 clients to talk frankly about how they could work together better. Now, the effort has grown far beyond that, boasting members like Pfizer, Quintiles, Eli Lilly and PharmaNet, which seek performance metrics that can be applied to many parts of pharmaceutical outsourcing.

It’s called the Metrics Champion Consortium (MCC) and, says president Guy Mascaro, it hopes to improve performance in the industry through improving relationships and refining more specific expectations about the jobs to be done. He uses a plumber analogy.

“The typical relationship between a service provider and a sponsor now is like a homeowner hiring a plumber,” Mascaro says. “The homeowner thinks: I’m paying you, and you’d better do what I want. That may not turn out the way he wants it to, because the plumber had no input on how the job should be done. If the two talked about the job, and agreed on expectations, they stand a much better chance of getting the job done in a way that’s cost effective.”

And so it can be for pharmaceutical outsourcing. Mascaro points to a recent MCC project in which Eli Lilly and Quintiles singled out 10 studies, and focused in on an handful of mutually agreed-upon core lab performance metrics.

Hit and Miss

“Some of the metrics were hit, some were missed,” says Mascaro. “But instead of saying, ‘Quintiles, you did a poor job,’ Eli Lilly went back and said, ‘Why didn’t we perform?’ Some of the issues were on Lilly’s side, others were on Quintiles’ side. And through the process, that relationship improved.”

How exactly? Here are direct examples from the 10-study project:

• The two companies compared Lilly’s protocols with Quintiles’ process and discovered that the two were not compatible. Lilly, they discovered, was collecting triplicates of electrocardiograms (ECG) but required that only one of the three copies be reported to investigative sites. At the same time, Quintiles’ autofax system was not set up to fax only one of three reports; it was an “all or none” system. Thus, Quintiles had to use a manual faxing process to accommodate Lilly’s protocol. To remedy the problem, Quintiles began working to automate the handoffs between departments within Quintiles to allow their ECG processing to flow more efficiently. Also, the company began updating the autofax system to accommodate Lilly’s protocols.

• The two companies found a problem in the process by which the “on-time” date was established. Lilly set optimistic start dates that were revised prior to the launching the study; Quintiles was using the initial dates provided by Lilly, not the updated start dates. The fix? Lilly is no longer setting optimistic start dates.

The MCC started out trying to finalize metrics for central labs, releasing its final version in 2006. Next? ECG. MCC released its performance metrics for that arena late last year. Now it’s focusing on imaging and contract research organizations (CROs). MCC recently expanded its board of directors, adding two members of the Association of Clinical Research Organizations (ACRO), Paul Colvin of PPD and Sean Larkin of PharmaNet Development Group.

Movable Framework

Doug Peddicord, ACRO’s executive director, hopes the MCC will streamline contracting. “Rather than having to create performance metrics for each new project—which is currently the approach to contracting, and deciding on what the deliverables are—if we as an industry can agree upon a framework of metrics that moves from project to project, that will allow much greater efficiency in contracting,” he says.

The key, though, is having all stakeholders—the plumber and the homeowner—at the table and gaining consensus.

Says Peddicord: “It’s all well and good for one party to say, ‘Here are the performance metrics,’ but it’s undeniably more efficient for the parties to get together and hash out reasonable criteria by which you’re going to judge performance.” That can be time-consuming and challenging, he says, but the advantage is that one can apply what’s learned to the next 10 contracts.

Collecting, Not Using?

Performance metrics are nothing new. Many sponsors collect them, then do nothing with them. Says Mascaro: “Service providers say, ‘[Sponsors] ask for metrics a lot, but don’t come and talk to us about them, or apply them in any constructive way.’”

In a recent survey MCC conducted of sponsor-company employees, only 9 percent of respondents said their employers effectively use performance metrics to improve relationships with CROs. Just 10 percent responded that their company uses performance metrics to improve productivity. The same survey showed that the desire for useful performance metrics remains high.

Next: CRO Metrics

Once such metrics standards are established, is there anything forcing companies to adhere to them? Just the desire for greater efficiency. “The industry as a whole must become more efficient and productive if it is to continue to thrive,” Mascaro says.

Currently, the Indiana-based MCC has more than 40 members, 10 of which are large pharmaceutical companies. The beta version of the CRO performance metrics is due in April 2009. After industry input, the final version is expected late next year.

by Suz Redfearn