Improve Decentralized Trials

USE CASE

Simple solutions for medication data collection and remote management.

Our products eliminate some of the challenges associated with decentralized trials, without introducing any new challenges themselves.

We help participants focus on their treatment and not the technology. Our solutions operate in the background, freeing the patient to focus on their health.

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.

Remote Management

Our web portal lets researchers monitor participants and make sure they are engaged and active in a study. The mobile app help participants build and stick to a routine. Present protocol-specific schedules that guide participants through their daily activities, including medication reminders, various alerts, and notifications about upcoming appointments (whether in-person or virtual).

Replaces Documentation

Dosing data is inherently accurate and automatically synchronizes with a central database. No need to double check, transcribe, or decipher illegible handwriting. It is also acquired remotely, and unlike paperwork, it does not need to be returned to a site for handling or processing.

Specific Benefits

Passive, Background Operation

Our monitoring and alerting features work automatically without blocking trial procedures or adding new burdens or processes.

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.

Potential for Fewer Blood Draws

For path-setting trials: use adherence as a measure of plasma concentration, in order to reduce (but never replace) blood draw activities.

Prevent Unnecessary Continuation

Failure to collect and act on adherence data means trials overrecruit and track participants for longer in order to drown out the statistical impacts. This results in potentially months of delay in getting to market.

Monitor Engagement

Use participant adherence as a barometer of trial engagement, to make sure that they are following the protocol, and take interventions if not.

Fewer Participants, Same Power

Basing final PK and PD analysis on a more selective group of highly adherent participants can yield the same power despite having a smaller number. This selective group can be achieved either by adapting enrollment or by stratifying data post hoc.

Learn More about the Products
that Power our Solutions

Med-ic®

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.

eCap™

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.

CertiScan® Platform

Consumer-quality software for clinical trials. Securely store, analyze, and action the data from smart packaging and other adherence devices. The CertiScan Platform includes web portals, mobile apps, developer tools, and a secure, central cloud.

Did You Know?

Data handling and pickup costs can account for up to 30% of drug development costs. Smart packaging solutions can greatly reduce these costs, potentially saving thousands of dollars per participant.

Med-ic and eCap are unique among DCT products in that they place no additional burden on the participant in terms of handling technology. They do not need to be configured, there is no battery to be recharged or replaced, and they do not change the blister package or bottle in noticeable ways.

Our CertiScan mobile app has been designed thoughtfully to maximize participant convenience and to be as low-burden as our smart packaging. Nevertheless, use of the CertiScan app is optional, and many of the decentralized benefits of our smart packaging are still available if participants or studies choose not to use the app.

The FDA requires risk estimation and mitigation strategies - REMS. Our solutions can help address the unique challenges you face conducting REMS in decentralized trials. We empower you to remotely detect and take timely actions on hazards like drug misuse, diversion, tampering, temperature exposure, excursions, and more.

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.

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.

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