Feb 26, 2015, 08:30
by
Michael Croft
By Clinical Informatics News Staff
February 26, 2015 | Earlier this week, DrugDev announced that the company has
been selected by TransCelerate BioPharma to develop and host the Investigator
Registry, which will bring together investigator information in one place with
one identifier: the DrugDev Golden Number. Having detailed profiles on
investigators in one place will let participating TransCelerate members look at
investigators’ study histories and performance metrics, and choose the right
investigators to launch their trials.
Clinical Informatics News caught up with DrugDev
President and CEO, Ibraheem Mahmood, for more details at the Summit for
Clinical Ops Executives—SCOPE—this week in Orlando.
DrugDev has always believed that the future of clinical
trials is about the investigator, Mahmood told us. Some people believe that
patients will be doing trials on their own, he said, but we don’t. The company
was started by physicians—Mahmood studied medicine—and believes the
investigator is the crucial player in the clinical trials process.
When DrugDev was bidding for the chance to build the
Investigator Registry, Mahmood said, it was the only company that approached
the problem from the investigator’s perspective. Anyone can merge spreadsheets,
the company contended, the technology is not hard. But not every tech company
can really connect with the investigators.
Of course, Mahmood now admits, the technology was a lot
more complicated than they realized. “We completely underestimated the
security aspect!” he says. But after much development, the product that
has emerged is one that he believes is technologically advanced while still
retaining the investigator connection.
Investigator selection is based on local relationships
and previous experience. The registry will expand a sponsor’s pool of
contenders by allowing more investigators to differentiate themselves. As an
investigator conducts more studies with TransCelerate member
companies—TransCelerate is composed of more than 20 biopharmaceutical
companies—more data is associated with the investigator’s Golden Number and
his or her profile becomes more robust.
DrugDev’s goal, and tagline, is to enable more trials.
More trials mean more successful therapies available to patients. The company’s
vision for that is larger than just an investigator registry. DrugDev has made
two recent strategic acquisitions. In 2013, the company acquired CFS Clinical,
a grant payment company and provider of contract and regulatory document
management services. In 2014, the company acquired TrialNetworks, an
award-winning trial optimization platform. Together, the three groups enable
sponsors to choose investigators, pay them, and start sites.
The company is on its way, Mahmood said, to being able to
offer full clinical trial operations solutions to make trials more efficient
and effective.
And what might those solutions look like? Mahmood opened
the keynote session at SCOPE on Wednesday and gave a rundown of what he
believes clinical trials technologies should look like.
In order to change the industry, he said, solutions need
to be lovely. They need to be beautiful in addition to working beautifully.
Mahmood mentioned goBalto as an example of a solution that is beautifully
designed.
They also need to be ready to implement. Mahmood advocates
making the solutions that are needed and putting them into play. He highlighted
several companies he believes are actively innovating including
ePharmaSolutions, Accenture Life Sciences, Cognizant, and ACRES.
And finally, Mahmood acknowledged that no one—not
sponsors, not CROs, not investigators—really wants to learn new processes.
Changing behaviors requires incentives. It’s up to the innovative solutions
providers to offer a little cake, he suggested.