The clinical trial technology company released a new suite of mobile applications, Bracket Patient Diary, Bracket RTSM, and Bracket Analytics.
Bracket Patient Diary is the latest version of a downloadable app for patients participating in clinical trials, which allows them to report symptoms and complete diaries using their own smartphone.
According to the company, the app helps pharmaceutical companies looking to implement Bring Your Own Device (BYOD) for patient-reported outcomes in clinical trials.
"As the complexity and data requirements of clinical trials increase, it's essential to have the appropriate tools available for stakeholders who participate in these programs," said Jeff Kinell, Chief Executive Officer for Bracket. "We developed these new tools with the intention of making clinical trials more efficient for pharmaceutical companies, investigator sites and patients."
Bracket also released platform updates to Bracket RTSM, its app for managing clinical supplies and randomization in clinical trials. In addition, the company has launched Bracket Analytics, a stand-alone tool for study managers and sponsors to view clinical trial progress.
Bring Your Own Device
Bracket released its first mobile app for RTSM in 2014 after which the company said adoption was great; however there was “a clear message that we should be doing more,” Adam Butler, Sr. Vice President, Strategic Development and Corporate Marketing, told us.
According to Butler, BYOD is one example of this. “We already have six active studies using BYOD mobile apps, several completed, and several more pending,” he explained.
“We are following the lead of the patients and sites who have really taken to this. We believe strongly that it is the future of clinical trial technology, so we have invested a lot of resources into it,” explained Butler.
Feedback, especially from sites, has been that “it increased efficiency and streamlined activities like collecting patient demographics or scanning barcodes on investigational supply,” Adam Butler, Sr. Vice President, Strategic Development and Corporate Marketing, told us.
After receiving this response and seeing the potential for other opportunities, the company decided to invest in a series of improvements, including its suite expansion to include better mobile tools.
“We also recognized the opportunity to expand our mobile offering to better serve patients and sponsors,” added Butler. “Bracket has used BYOD patient diaries in some really exciting ways, including collecting data during a phase II clinical trial, so we launched our first dedicated Patient Diary app to support the growing need for BYOD.”
While BYOD Patient Diary use is still receiving a lot of scrutiny, Butler said that the FDA, in particular the new office focused on Clinical Outcomes Assessments, has been helpful in providing information on regulatory expectations.
“The FDA especially has been encouraging companies to adopt more technology,” he added, explaining that Bracket’s RTSM and Analytics apps are based on systems that are compliant on all of the applicable regulations and guidance.