How can entrepreneurs fix “broken” clinical trials?

April 4, 2014 7:35 am by Stephanie Baum

“Clinical trials are expensive, slow and complex… We have an innovation desert.” Not exactly what you’d expect someone from big pharma to say. Craig Lipset is the head of clinical innovation at Pfizer (NYSE: PFE) — the biggest of the big pharma. He made the memorable introduction to ProofPilot at Blueprint Health’s demo day.

It is one of 46 companies in Blueprint Health’s portfolio. The healthcare startup has developed a Software as a Service to improve clinical trials for pharma, biotech and medical device companies by speeding up their launch and making them easier to manage.

Matthew Amsden, the CEO and co-founder, said a couple of the critical criteria in developing the SaaS was it had to be secure enough for the regulators and easy enough for clinical research novices. The company’s primary sets of customers are pharma, medical device and biotech as well as marketing companies.

Although it works primarily with principal investigators, it also works with outcomes agencies to explore consumer behavior. It charges a monthly subscription fee based on the complexity of studies. An average study generates $81,000. Amsden estimated that if it were to get 3 percent of research studies launched every year it could generate $180 million a year.

Last year the company has sales of $400,000 and this year Amsden said it expected sales to approach $1 million.

For example, for trial design it can develop randomized cohort research studies that include multiple arms with online and offline activities taking place at various study sites. It can build surveys, set measurement intervals, and identify incentives among other things.

One of the things that tends to hold up clinical trials is the recruitment phase — finding the right patients for the trial. Although ProofPilot’s service also includes recruitment on or offline, it’s not clear whether having a better set of software can do much to help that when you’re talking about a cancer study. The big issue there is how to identify ways to reach the research participants. It will be interesting to see whether ProofPilot can make a significant difference in that area.

It can also send collection devices and treatments, based on the study’s design, and collect data securely. The service also provides access to preliminary results when they’re available.

It’s also launching a seed round to support its sales division.

Several companies have been developing ways to make clinical trials easier to manage, many of them involving software. Transparency Life Sciences, which served as a mentor to ProofPoint, developed a platform to crowdsource clinical trial design.

Among some of the other companies active in speeding up clinical trial deployment are Clintrax Global, which focuses on negotiating clinical contracts. Regulatory Binder developed a tool to make it easier for hospitals to speed up compliance with clinical study regulatory documentation.

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