Info & Opinion
April 25, 2019
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David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
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With the basic features and functions in place, many providers of clinical trial software are busy refining the ways that users get information in and out.
Reports have been newly modernized at patient diary firm PHT, based in Boston, where Sheila Rocchio is VP of marketing.
She made it clear that the company isn’t remaining complacent about its electronic patient-reported outcome (ePRO) platform. Its new reporting system was developed by a third party, and tested within the ISO-validated process that PHT uses for all improvements to its system. ISO-vetted systems are billed as more robust than just any garden-variety software development process.
The new PHT reporting platform runs entirely online, inside a web browser. “We certainly had a robust set of reports around compliance and enrollment,” says Rocchio. But the new system is a quantum leap toward the zero-training sorts of systems that consumers expect on the web. Says Rocchio: “It's visually interactive and more compelling. It's a new interface.”
One inspiration was Mint, a financial services website for consumers. “You can color code areas where you're worried,” she notes. “You can see that data right away. You have a slick feeling that you're using simple, user driven reporting that makes it easy to find the data you want.”
She’s excited about the ability to quickly delve into the details of a diary project. There are different reports for different roles in the organization. Says Rocchio: “You can present the information that is most relevant based on the role.”
As an example, there is therapeutic intelligence, thanks to the ability to look across multiple projects or databases. ”Do I see better compliance in asthma patients versus central nervous system trials?” asks Rocchio. With a click or two, the PHT system can easily export data into other documents with PDF or Microsoft Office formats.
The new reporting engine can also be accessed from mobile devices, allowing clinical trial professionals with Android, Apple and other smart phones to check in to see pretty granular aspects of their projects. “You can check in and log in and see how compliance is at the sites,” says Rocchio.
For sponsors running the trials, PHT also tracks the operational aspects of the trial, monitoring esoterica such as how many people called the help desk.
PHT is also offering a web-only version of its system. There’s no hardware, nothing to plug into the wall or ship around the world. “The economics are a lot more appealing,” says Rocchio. “It's for observational data. It is about half the price of the traditional device-based model. It's a simpler set of questions. It is a less frequent stream of data from patients.”
In some cases, contract research organizations (CROs) are interested in the web-only ePRO offering. Rocchio says the system could facilitate patients enrolling themselves and periodically filling out a form.
The company is growing quickly, Rocchio says. “2010 was the best year we ever had,” she says. “We are seeing a lot of growth.” The privately held firm doesn’t publish financial data, but notes that a high share (perhaps 80 percent) of its trials uses both electronic data capture and electronic diaries. Some of its customers, clearly, are moving toward an era where paper is a thing of the past.