Reston, Virginia’s PICS offers professional research software called Certas.

PICS is charging a very reasonable $1,200 for Certas as the introductory price for an academic study with 30 participants. Larger projects might range as high as $30,000, depending on the scope of the research and the numbers of participants.

It’s important to note that the Certas pricing does not include the physical devices. The software is free, and the company charges on a per-participant basis. PICS pioneered the behavioral aspects of inexpensive medical devices for ordinary patients: it sells a smoking-cessation device and branched out into similar sleep- and nutritional-reminder tools.

To find out what PICS is doing in the life sciences, ClinPage checked in with Jami Obermayer, director of research. She’s clearly been nudging her customers, in academia and NIH-sponsored trials, toward electronic solutions. The software that can be loaded on any number of handheld devices, including patient cell phones or handheld smart phones from Palm.

Multi-device Trials

PICS conducts its own research. Obermayer prefers the term “participants,” which can embrace both patients affiliated with a specific investigative site and members of the public who have responded to advertisements.

Within the same study, she notes, different patients can use different devices. But the firm is clearly having the best experiences with Palm hardwear, as we’ll hear in a minute. The handheld devices can be programmed to have an impressive number of alerts to trigger patients to enter their own data.

Real-Time Clinical Data

“We conduct ecological momentary assessment studies,” Obermayer explains. “You capture information about an event at the time it occurs. We capture data in real time. But our product also allows for real-time data retrieval.” She says many competitors can’t do that.

Indeed, the Certas ePRO platform includes one system with electronic data capture and interactive voice response (IVR).  It’s all web-based and allows the scientists to see their own data in spreadsheet format during and after the trial. The company can also facilitate the sharing of data across multiple clinical sites. Certas Online is a service that allows researchers to securely store a copy of their protocols and all associated data on the company’s centralized servers.

The data from patients is secured and encrypted, but the Certas software is not yet 21 CFR Part 11 compliant. Thus it won’t be appropriate for some customers and trials sponsored by industry.

But it still sounds pretty easy to hit the ground running with the Certas technology. Says Obermayer: “It’s a researcher-configurable system. We provide a tool where the researcher is able to configure their protocol themselves.”

Tools For Non-Programmers

Certas offers two different questionnaire-development applications, including one that is drag and drop. And there are 50 template protocols available on the company’s web site. They cover a variety of therapeutic areas and often include the contact information of the scientist who first developed the instrument.

Some of the Certas customer-researchers are sophisticated. The company is supporting a National Cancer Institute study that is using wireless connectivity, and gathering information about patients’ diets and levels of physical activity. Obermayer also been interested in comparing the costs of paper-based trials with patient-reported outcomes and electronic modalities.

Two And A Half Eggs

Obermayer says it’s clear that the paper diaries cannot ensure the compliance that electronic ones deliver. In the NCI project, with 200 subjects, she has found that patients may claim to be adhering to the protocol but are unlikely to be providing valid responses in a timely manner. In some cases, patients put in answers that are hard to ponder: claiming two and a half eggs for breakfast, for example. “Instead of putting breakfast, they put ‘snack,’ ” she laments.

Treos that are automatically synced to the network can quickly alert the investigator that something is awry, she notes, which may make the extra cost worth it. But it all depends on the study.

The Right Trial

In general, Obermayer says, patients are more interested in providing data for activities that are interesting. “If you’re recording every time you have sex, or every time you have pain, patients are very compliant. The participant is very invested in these results.” That’s not the case in activities of less importance to patients, she notes.

Certas is supporting research on patients’ own phones, or phones acquired in batches by a researcher, says Obermayer: “A lot of times people don’t want an additional study phone. That does reduce cost.”

Clinical Bling

Patients using Treos, she says, have higher levels of compliance than those using more generic devices. “People complete the Treo questionnaires at a much higher rate than the cell phone,” she says. “They reported liking the Treo devices more than the cell phones. There is a status component with the Treo. People talked about how it was so cool to have the Treo. They show their friends.”

But that does not mean that she exclusively recommends electronic approaches. In the case of an HIV study, she says, the paper questionnaires in the project have never been validated in an electronic format. “I’m keeping them as paper-based forms,” Obermayer says. “Those forms have never been validated electronically.”

In the post-Vioxx, cost-sensitive era, the PICS solution is appealing. In general, post-approval studies could certainly benefit from more direct patient input. Certas offers an attractive, cost-effective way to give ordinary patients a way to provide data about their experiences.