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Industry makes a move on RTSM mobile apps

Tuesday, February 21, 2017

Parexel has launched a mobile app to extend its ClinPhone randomization and trial supply management (RTSM) service. The app employs barcode scanning technology that enables investigative site staff to track study medications and manage supply-related tasks throughout clinical trials.

“Tasks that include confirming correct treatment allocation, dispensing to patients and processing of medicinal product returns can now be managed more efficiently,” said Ken Faulkner, corporate vice president, Parexel Informatics. “The confirmation of the identity of shipments and kits and packs via barcode scanning is a new capability and adds confidence that sites are accurately processing and dispensing the right treatment to the right patient in the clinical trial.”

To check drug shipments, the camera on a mobile phone or device is employed to scan barcodes on medication kits. The app notes the time of the shipment’s arrival and verifies that the correct kits have been received. Staff can select study subjects in the app and determine which drug kits to dispense during site visits. Further, the app facilitates drug returns by site staff as well as the reconciliation of returns by monitors. The app can be used on Android or iOS platforms.

In 2014, Bracket released a similar mobile RTSM app to Google Play and iTunes that allows users to work with the company’s eClinical system. This technology also employs smartphone barcode scanning technology for dispensing medications. The app can be used to track, screen and randomize patients, and to collect patient diary information during visits.

“Randomization and drug dispensation are critical steps in ensuring drug accountability and patient safety,” said Adam Butler, senior vice president of Strategic Development and Corporate Marketing at Bracket. “Protecting the blind in a randomized study is important to trial and data integrity.” Bracket also offers companion apps for RTSM analytics and patient diaries.

Raymond Nomizu, director of Finance at Beacon Clinical Research, expressed enthusiasm about the ability to use mobile barcode scanning technology. “I think that would be amazing,” said Nomizu. “Now, when I get a shipment, I receive a paper list of all the medications. I have to record them, or log into a web portal and confirm that I have all of them.”
Using a barcode scanner to record medication shipments would eliminate steps, save time and prevent manual data entry errors. “I won’t have to stop what I’m doing and go to a website, log in and enter them manually,” said Nomizu. “And I’ll know it’s error free.”

An important benefit of mobile barcode scanning technology is to ensure the accuracy of drug dispensation errors during patient visits. In a typical scenario, the site investigator exits the patient exam room, logs onto a computer to obtain instructions for which kit to dispense, prints the kit number and takes the printout to a secure drug room to locate and withdraw the correct kit. To reduce the risk of a mistake, the investigator may have another staff member check the printout and medication kit. Preventing errors during this process is critical. “If you dispense the wrong medication, you jeopardize the trial,” said Nomizu.

Administering the wrong dose or giving actual medication to a placebo subject is also dangerous. With barcode scanning technology, the investigator can be sure that the patient is getting the correct drug assignment, which enhances patient safety. Parexel’s Faulkner pointed out that a key benefit of Parexel’s mobile app is “increased patient safety through barcode confirmation of allocated and dispensed medication.” With a mobile app, kit assignments can be confirmed in real time, reducing the chance that a patient receives the wrong one.

Noted Bracket’s Butler: “When used for drug dispensation, the barcode scanning feature allows for a much better drug accountability process. This also gives the sponsor better and more reliable data on drug assignments.”

Greater efficiencies, confidence in data accuracy and an improved chain of custody record are key benefits of the Parexel app that can help lower administration burdens for sites as well as CROs and monitors, according to Faulkner. Increasing the efficiency of tasks around inventory tracking and data entry also allows site staff to spend more time interacting with subjects during visits.

“We think one of the most important advantages is that it puts site staff and clinicians closer to their patients,” said Butler.

The ability to use a personal smartphone with barcode scanning holds great appeal for investigative staff, and is a promising addition to existing tools.

“I think mobile barcode scanning technology is absolutely the way to go,” said Nomizu. “From the research site perspective, I think that’s the missing piece.”

In general, challenges to adoption remain for mobile apps in clinical trials. “I think we’ll see a proliferation of apps over the next few years,” said Dr. Willie Muehlhausen, VP, Innovation at ICON. Multiple, disparate technologies can be difficult for sites to deploy.

“The challenge is having too many apps or devices,” continued Muehlhausen. “I don’t think sites appreciate being hammered with too many apps that they have to log into to use.”

One solution could be technologies that allow secure, single logins for multiple systems, such as those offered by the industry consortium SAFE-Biopharma and by Exostar. “This is something we have to take care of as an industry, not just as individual developers or companies,” said Meuhlhausen. “We have to figure out how to integrate and get individual apps to work together.”  


This article was reprinted from Volume 21, Issue 07, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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