Our smart packaging allows you to track your medication supply down the package level, and even to the unit dose level (i.e. per blister cavity on Med-ic®).
These combine to provide unprecedented visibility that can be extremely valuable, especially for expensive or sensitive IPs that are administered as injections or infusion.
Solutions
Analyzing Real-Time Consumption Rates
for Efficiency
Use the actual consumption rates from every currently-enrolled participant to accurately forecast your inventory needs. Ensure that depot supply is always aligned with site demand. We provide integration opportunities to make our data available in inventory systems, for example RTSMs.
CoolBlue™ Advanced Temperature Sensing and Alerts
Ensure that the product remains within safe temperature ranges, and receive notifications if any excursions are detected. Smart packaging can be configured to support whatever temperature management use cases are demanded by your studies.
Manage Expiry, Tampering, Defects, and Beyond
The onboard electronics can carry the expiry date. Unlike a printed label, this digital expiry date can be dynamically and remotely updated in the field, to reflect the latest stability findings. The sensors and our companion software also allow for remotely managing defects, tampering, and much more.
Specific Beneits
Objective, Precise Data
The sensors in our smart packaging can take accurate readings every minute. They have onboard storage for thousands of readings.
Cradle To Grave
Our tracking starts when drugs are sealed at a CDMO facility and continues through the entire use history of each package, up until the point of destruction.
Passive, Background Operation
Our monitoring and alerting features work automatically without blocking trial procedures or adding new burdens or processes.
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.
Serves as a REMS
The FDA requires risk estimation and mitigation strategy for trials where drugs pose serious risks, such as opioids. Our solutions and automated timely interventions can form a key part of your REMS.
Track to Individual Doses
Ensures precise monitoring and administration of medication, accurately tracking each dose taken by a patient.
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.
If your organization is using or planning to use our adherence data solutions, these supply chain solutions will naturally be available thanks to the smart packaging you had already put in place.
If your organization is not planning to use our adherence data solutions, we offer standalone CoolBlue™ tracking and logging devices that are exclusively designed to support our supply and cold chain features. Read more about CoolBlue™ products here.
Our supply chain solutions can help you meet corporate environmental and sustainability objectives. Superior forecasting and supply chain management can drastically reduce the required quantities of material and energy needed to conduct a trial. Read on to understand our solutions’ ROI, and contact our team for more information about determining the specific environmental ROIs.
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:
