CertiScan® Adherence Platform is consumer-quality software for clinical trials.
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
PIs, Monitors, Admin
PK/PD Teams
Participants
App & Tools
CertiScan® Study Portal
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
CertiScan® Mobile App
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.
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® QAP
Highlights
Accurate data for transformative 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.- 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.- 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.- 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.- 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
