Say goodbye to pill counts and medication diaries.
Many trials continue to use paper diaries. eDiaries™ are an improvement, but have their own pitfalls. Our smart packaging is the modern solution for modern trials.
Not only do we automatically collect data, but we automate analysis of this data as well.
Solutions
Automatic Dose Tracking
We make blistered and bottled smart packaging that automatically records each dose. Dose data can viewed instantly (for real-time use cases), or stored on the smart package for up 3 years later (for retrospective use cases). All devices are manufactured in ISO/GMP compliant facilities.
Automatic Analysis
Each dose is classified and labeled as per your protocol: “Adherent”, “Early”, “Late”, “Extra”, and more. We identify trends at the participant, site, and study level. Data export is fast and on-demand. Web dashboards are available for study staff to monitor and review data. Staff can opt in, to be involved as they see fit. And a mobile app provides participants with informative screens and self-motivation features.
Reconciliation
Final pill counts and drug accountability are automated: our smart packages know which doses were taken and which were not. For rare cases where digital data disagrees with the real world remaining doses or intake times, there are options to edit the dose history in ways that preserve the original records and ensure auditable traceability.
Specific Benefits
Objective, Precise Data
The sensors in our smart packaging can take accurate readings every minute. They have onboard storage for thousands of readings.
Passive, Background Operation
Our monitoring and alerting features work automatically without blocking trial procedures or adding new burdens or processes.
Reduced Participant Burden
Smart packaging requires less participant effort than paper diaries or eDiaries™, and is more accurate and objective.
Reduced Site Burden
Data acquisition is automatic and always accurate. There is no need to worry about transcription errors or paper documentation.
Lasts as Long as the Trial
All smart packages are designed to operate for 3+ years. Meaning that they will continue providing data regardless of trial duration, or trial delays, or other unforeseen events.
Learn More about the Products that Power our Solutions
The original smart blister package. Breaking a blister records the time and location (i.e. “8:00 a.m.” and “Day 1, Morning”). Med-ic® can be customized to work with any blister design and dose pattern.
The superior smart cap. Unscrewing and removing the eCap™ records the opening time. Several diameter and threading options are available to fit all common bottle types.
Consumer-quality software for clinical trials. Securely store, analyze, and action the data from smart packaging and other adherence devices. The CertiScan® Adherence Platform
includes web portals, mobile apps, developer tools, and a secure, central cloud.
Traditional drug diaries and pill counts are error prone, tedious, and not conducive to
remote or decentralized trials. Many are completed retrospectively, with poor recollection on the participant’s part. CertiScan® Adherence Platform unit-dose tracking, reminders, and coaching are automated, mobile-first, precise, and do not burden patients or staff.
The FDA, through its Critical Path initiative, has expressed an interest in the application of new tools to clinical trials. Automated data collection and medication adherence monitoring can be an integral part of this process.
ROI
Our experts have modelled the relationship between statistical power, sample size and medication adherence.
Their findings? For every 1% adherence increase, there can be a 2% reduction in trial size (N) while holding statistical power constant.
Considering that many trials currently only reach 50% adherence, there’s lots of room for improvement – and tremendous ROI.
Direct Savings from Reduced N
Processing a participant is expensive. Requiring a smaller sample size could amount to millions of dollars in savings.
Additional Weeks of Patent Protection
Smaller N means a faster trial, potentially by months. This could amount to tens of millions of dollars in additional revenue.
Compensate for Low or Slow Enrollments
It can be challenging to recruit enough participants - especially for niche diseases and even worldwide. Better data means fewer patients are needed overal.
Our mission is to create adherence-focused technologies that enable safer, faster, more efficient, and more innovative clinical research.There’s an IMC solution that will transform your next trial. Don’t wait, start the conversation with our team now.We’ll reach out in order to:
