Info & Opinion
May 23, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
We were looking around for how many USB, or “thumb” drives are sold every year. Alas, we could locate no statistics. We can report some companies are giving the data storage devices away as promotional devices. Other novelty firms sell plastic thumbs, padlocks, jewelry and poker chips with USB drives inside. For oenophiles, a tiny bottle-shaped USB drive can manage a wine cellar.
It’s safe to say that the modest USB drive is a user friendly, ubiquitous device. Without hype, without handwaving, the USB drive fills a need we didn’t know we had.
Now the people at Perceptive Informatics have figured out a novel way to use them in clinical trials. The firm is using 1-gigabyte USB drives to simplify the lives of clinical trial monitors. The company has put the monitoring component of the dominant Impact clinical trial management system, a program called MySites, onto a thumb drive. That software works in both online and off-line situations, allowing trial monitors to capture data when they’re not on the internet.
“There has been a demand in industry for this type of convenience for a long time,” says Kate Trainor, VP of operations for peri-approval operations at Perceptive’s parent company, Parexel International. Monitors from Parexel, a global contract research organization, are using the device and liking it, Trainor says. “Both the application and the data are complete and secure on the USB drive. You just need to plug it into a computer.”
That will allow monitors in the field a new option: ditch the laptop. Leave it at the office. Monitors will be able to insert the USB stick into a computer at an investigative site, do their work, and stop lugging a computer, power brick and assorted other cords and electronic debris.
Back at the office, Trainor notes, “when you do sync up, it will ask you questions to make sure you don’t have collisions in your syncing. It syncs on your computer and back to the enterprise software.”
The data is encrypted to the same level of security in the main Impact application. If the device is lost or stolen, Trainor says, nothing about a trial is at risk.
One of the communities that is most intrigued by the thumb drive, Trainor reports, is the IT department. “The IT community is loving this,” she says. “The logistics of managing these systems are beautiful.” Hospitals and medical clinics, either in the community or at major medical centers, are notoriously complex security environments, with firewalls and other measures that complicate the life of outsiders trying to work on their premises for a day or two.
Trainor goes on to say that the monitors themselves appreciate having less weight in their carry-on luggage. The module for monitors was redesigned recently, giving it the same look and feel as the larger Impact application.