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      CertiScan®: Adherence Matters


      Solutions
      Products
      CoolBlue® AI
      coolblue

      CoolBlue® AI is our temperature sensing technology that eliminates the need for separate expensive loggers. It may be directly integrated into our smart packages, allowing for dose-level monitoring and reporting of temperature history, temperature excursions and product status.

      Features

      Tracks exposures from -15 C to 65 C (5 F to 149 F)
      Logs the entire temperature history of each package
      Tracks total amounts of time exposed to particular temperatures
      Automatically computes pharma-relevant MKT values
      OK/NOK status lights support safe medication use
      3+ years of operational life span
      Sensor components are non-primary contact surfaces
      Compatible with GMP and GCP workflows

      Product Details

      CoolBlue® AI equipped smart packages (Med-ic® and eCap™) track temperature continuously throughout the cold chain, in addition to recording date and time of product removal from the smart package.

      Patients can easily see if the product is safe to use with OK/NOK status displays on the package, reducing any concerns about temperature or product integrity. Additional data displays and actions are available to patients through the CertiScan® companion app, helping them keep track of their adherence progress.

      CoolBlue® AI is an ideal add-on for clinical trials that involve injectable or temperature sensitive that involve smart blister packaged medication (such as the Med-ic Syringe® Pack). It is also valuable for commercial products where adherence and temperature control are crucial.

      Integrated with Med-ic and eCAP

      Standalone Trackers and Loggers

      Use Cases

      Accurate data for transformative solutions.

      Smart packaging is the ideal data source: it is accurate, automatic, and passive. There is no extra effort on the participant’s part since they were going to take a dose anyways (or not - which smart packaging can also detect!)
      This data feeds into the CertiScan® Adherence Platform and other software systems to power numerous solutions.

      Inappropriate medication use is widespread in clinical research. This can harm individual participant outcomes, jeopardize trial outcomes, and cause hidden errors that are only discovered post market or after publishing (such as a poorly titrated dosage or undiscovered side effect).

      Our solutions make it easy to detect and treat these harmful issues. Many protective features are automatic, such as mobile reminders, misuse alerts, targeted coaching.
      Detect and Treat:
      • Medication non-adherence
      • Medication misuse or abuse
      • Temperature exposure and spoilage
      • Expiry
      • Tampering, fraud, and other lot or batch issues

      Shorter trials that reach their endpoints more quickly can gain weeks or months of additional patent protection. This can amount to substantial additional revenue.

      Our solutions help studies reach last dose, last participant sooner.
      Improve timelines by:
      • Automating data collection
      • Replacing diaries and ePRO with smart packaging
      • Letting CertiScan preprocess and analyze data
      • Integrating CertiScan with RTSMs, EDCs, and other platforms
      • Conducting adaptive trials

      Clinical trials are becoming increasingly complex and expensive. Certain activities in a protocol seem straightforward on paper, but in practice can translate into dozens of hours of site work.

      Use our solutions to help eliminate needless overhead and streamline processes.
      Achieve efficiencies and reduce costs by:
      • Automating data collection
      • Basing site inventories on consumption rates
      • Conducting adaptive trials
      • Conducting decentralized trials

      New, technology-first strategies are transforming clinical trials. DCTs, participant diversity initiatives, and AI tools are changing from “nice-to-haves” into “must-haves”.

      Our solutions are modern tools for modern trials that can help researchers and other stakeholders gain and maintain an advantage.
      Adopt CertiScan and smart packaging to:
      • Meet FDA trial modernization guidelines
      • Model PK and PD with adherence data
      • Satisfy internal and external innovation requirements
      • Build accurate, objective datasets for use in AI models, participant diversity initiatives, DCT tools, and more
      • Publish unique studies that stand out in the literature
      Software

      Explore The CertiScan® Platform

      Our industry leading CertiScan® Platform unlocks the value of your adherence data. CertiScan® handles data retrieval, storage, analysis, and reporting.

      CertiScan® is a full suite that includes web portals, desktop software, mobile apps, developer tools, and a unifying cloud backend. You can use the entire platform as a whole, or a just subset that satisfies your particular needs.

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      Let's Talk

      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:
      • Deeply understand your particular needs.
      • Explore how Med-ic®, eCap™, and CertiScan®, can benefit your study.
      • Work collaboratively to prepare a specific solution that will exceed your expectations.

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