www.clinpage.com/article/inc_research_medidata_alliance -
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Published on: 1/29/2008
Last Visited: 2/12/2008
It's a non-issue," says Alistair Macdonald, senior VP of data services at INC Research.
Unplugging OC
Macdonald says an impressive seventy percent of the trials now being booked at the CRO involve EDC.His firm, based in Raleigh, North Carolina, is moving away from the EDC product of Oracle Clinical, like most of the rest of the industry.
Transitioning to Medidata, Macdonald says, makes a new and larger group of trials appropriate for EDC.Which is good, because his firm (which targets trials in pediatrics, oncology and the central nervous system) is starting to run projects in metabolic and cardiovascular disease.The INC-Medidata relationship provides an interesting window into potentially rising expectations for EDC across the industry as CROs embrace the technology and make the trains run on time.
Not surprisingly, Macdonald finds the Medidata EDC system, called Rave, versatile."With Rave, you can do just about any study," he says."We have not come across a study we couldn't run in Rave."
This isn't a typical partnership with a technology firm, Macdonald says."We came at the Medidata partnership in a different approach than we normally do," he says."We've been wide open to each other.
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Says Macdonald: "We don't have to explain anything to Medidata when we say, 'We need this by the fifth of the month.' " The need to change a time line is, to put it delicately, frowned upon.
INC's fastidiousness around time is, it believes, appropriate given the stakes."If we miss a database lock," Macdonald says, "it's been discussed with a customer for months.
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"We don't wait for things to go bad," Macdonald says.Translation: It's not permissible to blame your issue on some other person in some other organization."We see the early indicator, we get on the phone, and we hit the time line.The CEO's favorite statement is 'failure is not an option.' He's an ex-military guy and he makes it very clear."(That would be a reference to INC's James Ogle.)
Macdonald elaborates: "Pharma companies rely on us to make time lines that they couldn't make.
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Not everyone survives in that environment, Macdonald concedes, but one of his biostatisticians has been at INC for 13 years.
Some of the conversations between the EDC vendor and CRO, of course, can be tense.So the INC-Medidata relationship has built-in, face-to-face meetings early in every project."It's much easier to work and communicate with someone you've met face to face," says Macdonald.
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If they know something they tell us," says Macdonald.
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