- Specializing in Creating Customized IVRs, Voice, SMS, Chat and HIPAA Compliant Secure Message Applications
Specializing in Creating Customized IVRs, Voice, SMS, Chat and HIPAA Compliant Secure Message Applications
Medication Adherence and Dosing Diaries by Phone and Text
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Dose confirmations, missed-dose reasons and reminders that reach participants on any phone
Pill counts tell you how many doses are left at the next visit. They don’t tell you which morning was missed, or why. A short daily call or text can. Did you take this morning’s dose? If not, what got in the way? IVR Lab runs those check-ins for clinical trials, with schedules built around your dosing regimen and answers delivered by patient ID.
This is self-reported adherence, and we’re upfront about that. It works well next to pill counts, smart packaging or device data, and it reaches participants who won’t use an app. It doesn’t replace drug accountability at the site.
Planning a Medication adherence or reminder workflow?
Share your dosing schedule and the questions you want answered. We will sketch the check-in flow and show you what each answer looks like in the export.
Plan an adherence check-in21 CFR Part 11 and FDA guidance
FDA doesn’t certify software for Part 11, so no vendor can hold that certification, us included. Our audit trail was written against the audit trail and record integrity expectations of 21 CFR Part 11 and FDA guidance on electronic systems in clinical investigations. Whether those requirements apply, and how, depends on how your study uses the records. Compliance comes from your validated use of the system. We supply the controls, the documentation and the help.
What a check-in can ask
- Dose taken: yes, no or not sure.
- Missed-dose reason: from a list you define or open-ended response, transcribed.
- Medication-specific questions: for example whether a dose was taken with food.
- Safety screening prompts: written by your clinical team, with answers that need attention sent to the site.
- A spoken comment: in the participant's own words, recorded and transcribed.
Schedules built around the dosing regimen
- Once-daily or twice-daily calls or texts, at times each participant chooses.
- Changes by study day, for example daily during a run-in period and less often later.
- Rolling enrollment, with each participant's day 1 set when they enroll.
- Reminder calls or messages on no answer, busy, or no response.
When a participant doesn't answer
- Retry rules for unanswered calls.
- Callback requests, so a participant can ask to be called later.
- Nonresponse tracking, so coordinators can follow up while it still matters.
- Escalation emails to the site contact you choose.
Choosing the channel
- Work on any phone, landline included.
- Keypad answers or spoken answers on open-ended responses.
- A quick yes or no confirmation by reply.
- Little or no health information in the message itself.
- For longer adherence questionnaires or free-text answers.
- Participant authentication before data entry.
- Participants can call in to report a missed dose or a problem between scheduled check-ins.
- Toll-free or local numbers, with prompts in the participant's language.
Adherence data, organized by patient
- Patient ID and Site ID.
- Date and time of the call or message.
- Dose taken status.
- Missed-dose reason.
- Safety screening response
- Recording reference
- CSV export from the portal.
- Scheduled SFTP delivery.
- API integration when required, with documentation under a signed MSA.
- Site-level exports for each coordinator, and a combined file for the sponsor or CRO.
- Custom integration with your EDC, scoped to the system you use.
Adherence data in a regulated study
Run the check-ins in regulated study mode and every dose answer is linked to the frozen survey version, wording and recorded prompt that produced it. Answers can’t be edited or deleted, and keypad answers keep the label that was shown at the time. Read more about our audit trail for phone and SMS surveys
Test it with participants first
- A participant feedback pilot before launch, so the wording makes sense to the people answering it.
- User acceptance testing with your team against the spec.
- Mid-study changes approved by you and, in regulated studies, saved as new frozen versions.
Adherence check-ins often run next to diaries, visit reminders and follow-up calls. See everything we set up for clinical trial ePRO by phone and text.
Talk to us about your clinical trial IVR requirements.
Send us your protocol schedule, questionnaire, or patient communication plan and we will tell you how we would approach the workflow and what inputs we would need from your team.
Discuss your study workflowFrequently asked questions
Planning a medication reminder workflow?
Tell us the regimen, the sites and the languages. We will tell you how we would run it.
Talk to IVR Lab