DrugDev on the Investigator Registry, Designing Innovative Solutions

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.