Info & Opinion
April 24, 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
At the 2010 Society for Clinical Data Management meeting in Minneapolis earlier this month, one of the most engaging presentations was from Calvin Stewart, a program data manager at Pfizer. He provided a glimpse into the real world of clinical data management from the sponsor perspective.
For starters, Stewart said, forget about that newfangled email software you may have heard about on TV. Just drop it. Try the phone. “It is easy to bark an order in email,” he said. “But it builds a poor rapport. Don’t demand that things be done. Ask that they be done. This is basic people skills. Talk to them like they’re a person.”
Stewart was certainly a person. He had a few butterflies in his stomach at the podium but soldiered on anyway. Once he could sense a few hundred fellow data managers in the room were hanging on every word and impressed by his decision to persevere, he morphed into an older, gruff version of Oprah Winfrey.
Relating his own journey with the vendor community, Stewart said he had learned from hard experience that a commanding, belligerent approach did not turn out well. “I used all the bad practices that you could think for trying to manage a vendor,” Stewart said. “Everyone was so unhappy.”
Ten years ago or so, it seems, his employer may have had a few doubts about whether Mr. Stewart would be an ongoing part of the organization. As with a certain proportion of data managers, his first circle of relationships was with beige boxes that plug into a wall. Said Stewart: “I’m technical. I’m data management. Machines work nice.”
After a period of introspection, as well as a book by Dale Carnegie, he changed course. Six months later, even the most toxic vendor relationships on his program were warm and fuzzy. In a word, healthy. “They were performing at the level they should have been,” he related of vendors. “Management was happy. I was happy. I still had a job.”
He adopted a more collegial, less dictatorial manner. “Vendors have a special skill set,” he said. “Ask for their input on the issues you’re actually dealing with.”
As an example, he related what he described as a relatively difficult project deadline. The data management had been outsourced to one functional service provider (FSP) firm in the United Kingdom. But the deadline was so critical that Stewart decided to give the work to another firm. “The relationships with both FSPs were good,” Stewart said. “Everyone understood the reason I was moving the study.”
Still, there was no doubt there was some awkwardness for the second firm in the mix. Said Stewart: “They are picking up a study that has been in conduct, being run by another FSP, and they’re taking it over.” One nuance: the trial was being conducted entirely on paper, which was a rarity. Of thirty studies in his group at that time, just two were on paper.
From Stewart’s perspective, it’s not that the legalities of the contract were irrelevant. Instead, the key to good relationships is a certain level of ongoing contact and personal connection with the vendor organization that some old school, imperial data managers might not have tried themselves.
The planning for the critical study began in January, with the actual hand-off from one firm to the other in the summer. The database simply had to be locked in November. And guess what? It was. Despite the paper case report forms.
Stewart didn’t reveal any more of his secret sauce. He simply said: “We were able to lock this database in eight business days. If you stick with [vendors], they will stick with you. If there weren’t a good relationship, that wouldn’t have happened.”