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FAQ

Questions about adherence monitoring in clinical trials.

Grouped the way evaluations usually run: study design first, then data and access, then the device.

FAQ

Study design.

Clinical Use & Study Design

  1. Is Pill Connect suitable for use in clinical trials and launched drug programs?

    Yes. Pill Connect is suitable for use in clinical trials as well as launched drug programs where objective medication adherence data is required for patients or participants dosing at home.

  2. Is Pill Connect suitable for decentralized or hybrid clinical trials?

    Yes. Pill Connect supports decentralized and hybrid clinical trials by enabling medication adherence data to be collected remotely, without requiring participants to attend site visits solely for adherence monitoring.

  3. How does Pill Connect compare to pill counts or patient diaries?

    Pill counts and patient diaries are retrospective checks: you learn whether doses were missed only after the fact, when the bottle is counted at a site visit or the diary is reviewed. By then the non-adherence has already happened and the window to act on it has passed.

    Pill Connect is a detection service, not another count. It records each dispensing event with a time-stamp and alerts your site team the moment dosing slips, so a problem reaches you while there is still time to act. You do not wait for an empty bottle to find out, and there is nothing extra for the patient or site to do.

  4. What adherence data does Pill Connect collect in a clinical trial?

    Pill Connect records dispensing events, including the date and time each individual pill is dispensed, as well as bottle swap events. This data can be used to support medication adherence analysis during a clinical trial.

  5. What happens when a participant's dosing slips?

    Pill Connect detects the slip as it happens, from a single missed or delayed dose to a pattern building over days, and emails your site team with exactly what happened and when. Nothing waits for the next site visit or database lock, so the issue surfaces while there is still time to act on it.

  6. How does the site team act on an alert?

    The alert gives the site team the detail they need to reach the participant early, before a missed-dose pattern hardens. What the team learns and the action they take are captured alongside the dosing record, so each alert ends in a documented outcome: what was detected, what was done, and the dosing that followed.

FAQ

Data and access.

Data, Access & Monitoring

  1. How is data collected from the Pill Connect dispenser?

    The Pill Connect dispenser records events such as pill dispensing and bottle swaps. This data is read by a smartphone app and transmitted to remote monitoring platforms. This process is done in the background with no need for the patient to open the app or do any actions. It just needs the app installed, configured at the start of the study for their bottle and to come into range when the dispenser has new data.

  2. Can sites or CROs access adherence data remotely?

    Yes. Adherence data recorded by Pill Connect is transmitted via smartphone to remote monitoring platforms, allowing sites and CROs to review adherence information remotely during a clinical trial. This can be email alerts that are configured at the start based on specified content, timing and triggers, or by requesting a data export.

FAQ

The dispenser.

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Device & Technical Specification

  1. What types of pills are compatible with Pill Connect?

    The standard Pill Connect dispenser works with capsule sizes 0 to 5 and a wide range of tablet sizes.

  2. What bottle types is the Pill Connect dispenser compatible with?

    The standard dispenser fits bottle neck finishes 38-400 and 33-400. If a different bottle type is required, the dispenser can be customised to fit alternative neck finishes.

  3. What is the battery life of the Pill Connect dispenser?

    The dispenser has a battery life of up to 12 months in dispensing mode. It is powered by a sealed internal battery that cannot be replaced. During shipping, the device remains in a low-power sleep mode and is activated when first attached to a bottle.

  4. Does the Pill Connect dispenser include child-resistant features?

    Yes. The Pill Connect dispenser is certified to ISO 8317:2015 child-resistant and senior-friendly (CRSF) standards when used with 38 mm and 33 mm diameter neck bottles and it’s 45mm protective top cap.

  5. What materials come into contact with the pills?

    All materials that come into contact with pills are FDA-compliant, food-grade materials. Material compliance certificates can be provided on request.