Pill Connect, the smart dosing device company, today announces its acceptance onto the leading CDMO’s (Contract development and manufacturing organization) smart packaging supply program.
Following an intensive validation process, the device has passed the product qualification criteria for operation, robustness and handling. In addition, all GMP supplier audits have successfully been completed enabling both the CDMO and Pill Connect to actively market its technology as ready to use in clinical trials.
For context, recent guidance from the US Department of Health andHuman Services Food and Drug Administration encourages the use of smart packaging technologies as a tool to more accurately understand a patient’s exposure to a drug during a clinical study. There is a growing package of evidence to demonstrate that integrating smart packaging solutions into clinical trial strategies can improve medication adherence to dosing protocols and provide a comprehensive understanding of a participant’s exposure to the study drug.
As the only per pill technology that integrates seamlessly onto an existing pill bottle. Pill Connect can now credibly enable clinical trials.
“Our device provides real time, pill level monitoring to enable oral solid dose regimens to be optimised instantaneously, mitigating against poor adherence and delivering better outcomes for participants” said Dr. James Burnstone, CEO at Pill Connect. “Our you can count on us’ value proposition reflects the fact that our device has been designed with a 360o perspective, addressing the common compliance challenges faced by both pharmaceutical clients and trial participants.”
This is the latest in a series of good news stories for the developer of Smart Dispenser technology. Pill Connect has recently successfully collaborated with the University Medical Center Groningen in the Netherlands to deliver a clinical proof-of-concept study showing that Tuberculosis (TB) patients can use Digital Adherence Technology(DAT) with acceptable reliability.