Info & Opinion
March 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Ask a contract research organization (CRO) like Parexel how many employees it has overall or in a general region, and it's happy to say. But how many employees in India? As in exactly? Lips are zipped. At Kendle, too. And Covance.
So why are head counts in India such sensitive numbers? John Kreger, a financial analyst with William Blair, has been scrutinizing the clinical research outsourcing space for 15 years. He says that though all the CROs are watching China and India closely, not all are there yet in force.
"We believe their actual presence in both countries is fairly small," Kreger says. "They try to ramp resources and capabilities as clients demand ramps, but not before. So they probably don't want to go on record because their employee counts and other metrics in India are still fairly small."
Kohkan Shamsi, India-based CRO Manipal Acunova's CEO for the U.S., laughs when we ask about the headcount secrecy. Then he offers a guess about its origins. In 2007, he says, after all the big professional services firms like Ernst & Young and KPMG began trumpeting that India would be the Next Big Place for Clinical Trials (NBPCT), CROs felt pressure to be there—immediately. “That created a mushroom effect among CROs, like the dot-com boom,” says Shamsi.
U.S.-based CROs that weren't there scrambled to find troops. Those with a presence scrambled to find more. The pressure built. Soon sponsors wanted CROs in India to be full-service, offering drug safety, data management and central lab services, in addition to having plenty of clinical staff. Though some of the U.S.-based CROs weren't yet supplying all of those services, Shamsi says they sought to create that impression.
In an attempt to become full-service through alliances, other large western CROs began forming joint ventures with local firms. Unfortunately, Shamsi says, many of those alliances did not flourish: “They broke apart. The local personnel just didn't have the experience to do global clinical trials, to work with the FDA; they didn't have a global view of trials.”
Once the early alliances crashed and burned, a handful of the large U.S.-based CROs were back to square one—but that leaves some firms well behind industry leader Quintiles, which came to India in 1997 and has more than 1,200 employees in five cities.
“No wonder they don't want to say how many employees they have there,” Shamsi says. Manipal Acunova, by the way, has 205 employees in India.
—by Suz Redfearn