Pill Connect - Medicine Adherence Monitoring

The challenge of understanding real-world dosing behaviour in clinical trials

When participants dose outside the clinic, adherence is difficult to measure accurately. Missed, delayed, or irregular dosing may go unobserved for extended periods, particularly when relying on pill counts or patient diaries.

As a result, trial teams often lack timely visibility into real-world dosing behaviour, increasing uncertainty when interpreting data and assessing whether observed outcomes reflect the therapy or adherence patterns.

When adherence issues are identified only retrospectively, opportunities to understand why non-adherence occurred may be limited.

Without visibility into when dosing deviations happened, it becomes more difficult to explore potential contributing factors or provide timely support. This lack of context can add variability to adherence data, making it harder to distinguish meaningful patterns from background noise.

What real-time adherence visibility enables

By providing objective, time-stamped adherence data as dosing occurs, Pill Connect supports trial teams in understanding and responding to real-world dosing behavior.

Better-informed site interactions

Equip site teams with objective adherence information to support discussions with participants during scheduled visits.

Earlier awareness of dosing deviations

Identify missed or delayed doses sooner than periodic reviews of pill counts or diaries.

Improved context during data review

Interpret study data with greater clarity by understanding adherence patterns alongside other trial variables.

Support for decentralized and hybrid designs

Maintain visibility into adherence when participants dose at home and site visits are less frequent.

Reduced reliance on indirect adherence measures

Complement or replace methods that depend on self-reporting or retrospective review.

FAQ

Questions & Answers

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Clinical Use & Study Design

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.

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.

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

Pill Connect provides objective, time-stamped dispensing data, reducing reliance on indirect adherence measures such as pill counts or self-reported patient diaries, which can be incomplete or inaccurate.

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.

Data, Access & Monitoring

How is data collected from the Pill Connect dispenser?

The Pill Connect dispenser records events such as pill dispensing and bottle swaps. This data can be read by a smartphone and transmitted to remote monitoring platforms.

Can sites or CROs access adherence data remotely?

Yes. Adherence data recorded by Pill Connect can be transmitted via smartphone to remote monitoring platforms, allowing sites and CROs to review adherence information remotely during a clinical trial.

Device & Technical Specification

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.

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.

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.

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.

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.