On the eve of the Drug Information Association (DIA) meeting next week, ClinPhone announced ClinPhone Compact. It’s a web-based tool, using the telephone and the internet, to manage patient randomization and drug supplies. To use the jargon, Compact is both an interactive voice response (IVR) and interactive web response (IWR) system.

This means that the official news release deluge associated with DIA has begun.

Some of the features include real-time progress reports, central randomization, emergency code breaks, medication dispensation, and supply management for sites and depots. ClinPhone says Compact “minimizes the need for programming, testing, and validation whilst allowing for essential study-specific customization.” Unlike a project that takes a few months to be custom-programmed, Compact assignments will start rapidly.

We checked in with ClinPhone’s senior VP of software and marketing, Patrick Hughes. He describes Compact as a lower-priced, less exhaustively customizable offering in the software-as-a-service mode. “We want to deliver the same quality but to a large extent in a preconfigured way,” says Hughes. “That’s what customers said they needed. They don’t just want to give us their most complex work, which they know we can deliver. They want to give us some of their more normal, standard business. They want something that is good enough but without all the bells and whistles.”

After The Acquisition

Hughes reminded us that he’s relocated from England to … the U.S. With headquarters in Nottingham, England, ClinPhone is deliberately injecting a bit of southern California technology mojo into its DNA, by way of its 2006 acquisition of DataLabs, based in Irvine.

The company appears to have had no difficulty digesting DataLabs. ClinPhone’s most recent earnings announcement is a few months old, but it noted that revenues were up 27 percent in the year ended February 2007. Earnings were up 41 percent. With more than 750 employees, ClinPhone is the biggest pure technology company operating in the clinical trial space. It is the big dog and nicer than many of any size.

Major Expansion

As the leader in interactive voice response (IVR), ClinPhone also has solutions for supply management and clinical trial management. It appears that ClinPhone’s purchase of DataLabs is already paying off, with a recent EDC customer win (Kendle International, interviewed here by ClinPage) and the first certification from the Clinical Data Interchange Standards Consortium (CDISC), which ClinPage wrote about here.

Hughes is understated by nature, and (while proud of what the company can do) not one to boast. “We are not assertive enough to say that right at this moment in time we can answer all the ills of the life sciences using the ClinPhone technology suite,” Hughes says. “Clients are going to pick the best of breed.”

Next Generation Systems?

He commented on another story on this website last spring, in which Wyeth’s Ira Spector speculated about the next generation of electronic data capture systems. “We agree with Ira’s comments,” he says. “There will have to be next generation systems. They can’t just keep delivering what each of those niche systems delivers at the moment.”

Hughes is excited about sponsors exploring adaptive and flexible trial designs. It’s a profound shift, and it’s going to happen, he says, citing efforts at Pfizer and Wyeth that are more than just toes being dipped into the adaptive waters. “People are more serious about it now than I’ve ever seen them. This is a significant way we will change the way we do research,” he says. “You need technology to help manage that process.”

Perhaps 18 months ago, he says, governmental officials were more reserved about adaptive trials. Now the green light is on. “Adaptive trials will be a big focus for the company in the next two years,” Hughes says. “We’ll hear more and more about the adoption of adaptive trials. We don’t see, in regulatory bodies, the objection to sponsors adopting this kind of methodology.”

Enabling Adaptive Designs

Hughes says that his firm will step forward to assist sponsors navigate their options when adaptive designs are chosen. “As adaptive trials become more prevalent, ClinPhone will be at the forefront of that in terms of being able to deliver technology that is necessary to implement the decisions. The paper chase wouldn’t lend itself to the benefits you’re trying to get out of it.”

This year, Hughes reports, ClinPhone will put about 13 percent of revenues back into research and development. One item on the R&D project list is the ability to pass data between ClinPhone applications, especially its tools for EDC, IVR and CTMS.

The effort will ultimately produce a single application with one user interface. It should be completed in mid-2008. Some early aspects of the work will be on display at DIA next week. Hughes is inclined to speak glowingly of the company’s clinical trial management system (CTMS), about which we’re preparing a separate story.

e-Diary Views

ClinPhone is participating in the electronic patient reported outcomes (ePRO) niche, but not by using a handheld personal digital assistant (PDA) to record the experience of patients. ClinPhone knows a thing or two about shipping drug supplies all over the world.

With that experience, the company is not keen to worry about shipping Palm Treos or Windows Mobile handhelds across borders and time zones. “We don’t want to become experts in the logistics management of getting hardware out in the field,” Hughes says. “We see the headaches that causes. I don’t want to see a room at ClinPhone, charging up PDAs by the hundreds, knowing that one out of 100 will fail.” He might moderate that view in a future epoch of always-on, web-enabled smart phones. 

Beyond the sheer details of such shipping challenges, he says, the handheld diary business would not be in concert with the company’s philosophy. “We want to make people’s lives easier.”

Adoption Curve

Hughes is not alone in saying the industry is genuinely embracing technology about as rapidly as it can, considering its cautious psychological profile. He is not one to sugar-coat the message: “We recognize that the [approach of] the industry and the clinical research space are one of extreme conservatism. For good reason. Adopting technology, especially technology which is unproven, has been challenging for sponsors for the last few years.”

But the tide is indeed turning, Hughes believes. His company’s technology and the tools of other companies are regarded with less suspicion. “Companies are now more likely to adopt,” he says. “We see much greater maturity in our customer base and in our own offerings. We’re now at the stage where adoption is becoming more widespread than ever before. We’re seeing [that] the take-up rates of our software and services is maturing far more quickly than 2 to 3 years ago.”