Consumer-quality software for clinical trials.

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 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

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

Focus on the right participants

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.

Examine site and study-wide trends

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

Instant data reporting and exporting

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.

Receive alerts and targeted insights

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

Dose editing, reconciliation, and more

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.

Simple, convenient interactions

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.

Built-in security

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

IT-friendly

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

Bridge to greater functionality

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

Additional information and options

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 Mobile App

For participants. Features for data acquisition and self-improvement.

Intuitive, powerful, study-controlled Home screen

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.

Smart medication reminders

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Trends, coaching, and gamification

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Appointment reminders

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CertiScan Cloud

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

CertiScan QAP

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

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.

Safer Research

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

Faster Research

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

More Efficient Research

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

More Innovative Research

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 literaturee

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Consumer-quality software for clinical trials.

Highlights