The recent annual meeting of the Society for Clinical Data Management (SCDM) had its first annual “Data Driven Innovation” award. The inaugural prize was presented to Sirion Therapeutics and clinical technology suite supplier DSG of Philadelphia.

It’s worth noting something from the SCDM is not just another trade show gimmick, selected by journalists or consultants. The SCDM membership use clinical technology on a daily basis.

DSG’s eCaseLink solution has been used in four completed and two ongoing trials at Sirion. The system combines the functionality of several major systems for industry-sponsored clinical trials: patient randomization, interactive voice response (IVR), electronic data capture (EDC) and drug supply management.

In some trials, some of those systems are carefully stitched together by hand. DSG says that’s unnecessary. “You don’t have to have another implementation of another system,” says Tony Varano, the company’s CEO. “We were able to do this at a fraction of the cost” of combining separate IVR and EDC solutions.

Hot Tablet

Sponsors of clinical trials with in-house randomization or IVR systems will probably keep using them. But other sponsors or contract research organizations working to tie together IVR and EDC systems could be tempted to take a look at what DSG has built. “Why do we need another vendor to provide a randomization scheme?” asks Suzanne Lamerand, VP of data management at DSG. “We can manage that once it’s in the system.”

Lamerand, a recent DSG hire, spent eight years at a unit of Johnson & Johnson. At the SCDM event, she was showing off how the Sirion data was collected on a Fujisawa wireless tablet. “It makes it possible to do an e-source study that’s very portable,” she says.

The computer in question had a surprisingly appealing, even inviting design and a beautiful screen. Lamerand concedes that the paperless, digital nature of “e-source” still makes some people nervous. It all depends on the trial, she says. But in Phase I or post-approval studies, the device may be appealingly light and efficient.

E-source ROI

The tablet in question is too big for a pocket, but small enough for nurses or physicians to carry around all day. In Sirion’s case, the device made it possible to gather some data without paper. The word “e-source” is one that some in the industry are skittish of. DSG is embracing it.

Varano says e-source will become more important and accepted over time. In discussing some of the budget items in any typical trial, he shakes his head at what are, for him, unfortunate extravagances for travel and hotels as monitors make their grueling and costly trips to visit rooms filled with paper.

On a large trial, he estimates, a $500,000 investment in technology that facilitates e-source could potentially yield ten to fifteen million dollars in savings through less monitoring. Says Varano: “There is going to be a lot less monitoring. E-source is going to allow the reduction.”