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      CertiScan®: Adherence Matters


      Consumer-quality software for clinical trials.​

      certiscan adherence platform

      Highlights

      Stores, centralizes, and syncs adherence data
      Study Portal for data management and remote monitoring
      Participant app with reminders, self-tracking, and alerts
      Tools for CDMOs, IT system integrators, and more
      Analytics, reports and exports on-demand, in real-time
      Role-based access control for study personnel
      Secure, private and anonymous by design
      Complies with 21 CFR Part 11 and other regulations

      Overview

      CertiScan® Adherence Platform is a suite of software tools that centralizes adherence data. Depending on your protocol, you can use the entire platform as a whole, or a just subset that satisfies your requirements.

      All user interfaces will adapt to each user depending on their role in a study. This ensures that each stakeholder’s CertiScan® experience is intuitive and focused on their particular needs, workflows, and objectives.​

      Site Staff​

      Minimal user interface. System handles most data organization and analysis. Alerts and highlights are only surfaced when attention is needed.

      PIs, Monitors, Admin​

      See trends per study or per site. Gain assurance that study is on track and ROI objectives are being met. Use data to make informed decisions.

      PK/PD Teams​

      On-demand adherence data and derived insights across the entire participant population. Filtering, analysis, and reporting.

      Participants​

      Optional mobile app for adherence reminders, remote monitoring, self-monitoring, targeted coaching, and self-improvement.

      App & Tools

      certiscan study portal

      CertiScan® Study Portal

      Staff portal. Visualize, analyze, and manage participant data in an attractive and role-based web application. Works in any modern browser.

      Labels like “Adherent”, “Late”, “Missed” are automatically applied to each dose based on the participant’s medication regimen. This is aggregated into powerful dashboards. Participants with low adherence or aberrant use are highlighted.

      Monitors and study administrators can do site vs site analysis to identify systemic issues early and see overall study progress.

      Generate CSV and PDF/A files on demand for single participants, sites, or whole studies. Even large files generate within seconds. Advanced exporting available through an API.

      Targeted, automated coaching messages can be generated per participant to help them improve.

      Smart packages automatically record every dose time. Easy reconciliation features ensure dosing records always match dosing reality. Defect tracking, supply chain and cold chain management. Post-study data collection and alignment in centralized depots.

      CertiScan® Connect

      Uploads Med-ic® and eCap™ data to CertiScan® Cloud. Fits seamlessly into site workflows. Makes smart packaging technology - which can be new and unfamiliar - feel intuitive.​

      When a user brings a smart package near a CertiScan® reader, download occurs automatically. No mouse or keyboard is needed. The on-screen displays are minimal, consisting of subtle pop-ups to show the download status.

      Each smart package is checked for authenticity and integrity before forwarding the data onwards to be stored, analyzed, and reported in CertiScan® Cloud and existing systems

      There is one easy installation file, with no configuration. CertiScan® Connect runs in the background (no launcher, windows, accounts, or login). Updates automatically.

      CertiScan® Connect can link directly to screens in other CertiScan® applications for reporting, insights, dose reconciliation, and defect management.

      Works securely with no need for site staff to authenticate or create accounts. Available on Windows and macOS (CertiScan® Mobile App is available for phone-based data acquisition). 3rd party interoperable: offers a documented, developer-friendly and FHIR-aligned WebSocket API.

      certiscan connect
      certiscan mobile app

      CertiScan® Mobile App

      For participants. Enables data acquisition and self-improvement. Supports two modes: a fully-featured rich app experience, or a minimalist blinded mode. Available on iOS and Android.

      Display a daily medication schedule that updates live in response to new data. Or for studies needing a lighter patient experience, simply show a screen with success messages whenever new data is uploaded.

      Each participant experience is our first priority. That is why our medication reminders are optional (participants can disable them) and context-aware: they will only be delivered if the smart package hasn’t dose intake data hasn’t been retrieved from the smart package yet.

      At the study’s discretion, prewritten, consistent coaching messages may be set up and delivered in response to certain aberrant dosing patterns. Even if automated coaching is not enabled, the CertiScan app has powerful yet glanceable data visualizations to help participants practice self-tracking and self-improvement.

      In addition to medication reminders, participants can set up reminders for in-person or virtual appointments. These appointment events show up in their daily schedule alongside their prescribed medication, keeping everything together in the same headspace.

      For studies who do not want or do not need the full-features list mentioned above, the app can operate in a blinded mode, with a minimal user interface that just prompts the user to scan and go.

      CertiScan® Cloud

      Secure, central store of smart packaging adherence data. Syncs data between clients. Enforces role-based access control.
      certiscan qap

      CertiScan® QAP

      Quality assurance and provisioning of smart packages in manufacturing/GMP environments.
      developer tools

      Developer Tools

      APIs: Read and write study data in standards-conformant JSON.
      Mobile SDK: allow 3rd party apps to communicate with Med-ic® and eCap™.
      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

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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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