Adherence, managed as a trial risk.
You watched a missed dose reach the site the day it happened, not months later at a pill count. That is adherence managed as a risk to your trial data while the study runs, the risk-based quality management ICH E6(R3) asks of sponsors.
What you watched
- A coordinator enrolled a participant with one form, and the pack carried one QR code.
- The participant installed the app, scanned the dispenser and took the first dose in the same sitting.
- Doses recorded themselves whether the app was open or the phone was in a pocket.
- A missed dose ran the plan the sponsor approved: a two-tap survey to the participant and an email to the site.
- The platform emailed the site once all week. No one watched a dashboard.
What happens next
- Tell us about your study. Indication, phase, site count and timelines. The form below reaches the team directly.
- See it configured for your protocol. We set up a console like this one with your cohorts, thresholds and the communication plan your team approves.
- Run it. Sites hand over dispensers at a visit or post them. The platform does the watching from the first dose.
Built for risk-based trials, certified and inspection-ready
Built for risk-based quality management
ICH E6(R3) asks sponsors to find the factors critical to a trial’s quality and manage the risks to them. Dosing is one of those factors, because exposure, endpoints and safety all rest on it. Per-dose timestamps let your team hold adherence as a monitored risk with a pre-agreed response, evidenced while the study runs rather than reconstructed at database lock.
Certified quality and security
Pill Connect is certified to ISO 9001:2015 (quality management) and ISO/IEC 27001:2022 (information security), audited by SGS. Either badge verifies the certificate against SGS’s public register.
Conformant hardware
The dispenser is CE marked — its EU Declaration of Conformity covers the Radio Equipment and RoHS directives — and carries an FCC Supplier’s Declaration of Conformity to Part 15 for the United States.
21 CFR Part 11 and data integrity
In a trial, this platform is the first durable repository of the source data it records, so Part 11’s controls are enforced in the product: role-based access, authority and device checks, signatures linked to records, and the append-only, tamper-evident audit trail you opened in the demo. These are the properties data-integrity reviews ask about — ALCOA+ in GxP terms, and the same ground EMA, MHRA and 21 CFR Part 11 cover.
HIPAA and GDPR
Pseudonymised is not exempt: adherence records carry timestamps, so in US trials they remain protected health information and Pill Connect operates as a Business Associate — built to the Security Rule’s safeguards, with encryption in transit and at rest, role-based access, immutable audit and one isolated instance per trial. Under UK and EU GDPR we act as a processor, with per-trial data residency and participant-level cryptographic erasure.
DHT evidence, sponsor-shaped
Our verification, analytical-validation and usability evidence is organised to the DiMe V3+ framework, with Context-of-Use statements and BIO DHT-template crosswalks — the very structure pharma sponsors are asking FDA to standardise for digital health technologies. Mid-study software updates run under per-trial version pinning with tiered change notification, the predetermined-change-control shape sponsors want from DHT vendors.
Discuss your trial.
Interested in using the Pill Connect dispenser in your trial, or want this sandbox configured for your protocol? Get in touch.
- Emailinfo@pill-connect.com
- LinkedInpillconnect