The right ePRO system for a global Phase 3 with licensed instruments is not the right one for a 40-participant academic diary study. Here are the categories of vendors, the criteria that separate them, and where Capture fits.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Enterprise eCOA | Unified EDC + ePRO | Survey tools | |
|---|---|---|---|
| Licensed instrument migration service | |||
| ePRO in the same audit trail as EDC | |||
| Part 11-aligned controls | |||
| Self-serve build | |||
| Typical study size | Large | Small to large | Small |
The short version
Criteria
| Criterion | Why it matters | Capture |
|---|---|---|
| Device model | BYOD lowers cost and friction; provisioned devices control the environment | Browser-based BYOD, no app; clinic tablets supported |
| Scheduling | Visit-based and recurring diaries with windows | Visit-based or recurring, soft/hard/warning/auto-close windows |
| Reminders | Compliance depends on them | When due, next day and before window closes, quiet hours |
| Licensed instruments | Licence tracking and faithful migration | Licence number, holder and expiry per form; collection blocked if lapsed |
| Compliance controls | Audit trail, access control, signatures | Field-level audit trail, roles, re-authenticated e-signatures |
| EDC integration | Separate systems need reconciliation | ePRO, EDC and eConsent in one study |
| Cost and set-up | Small studies cannot absorb large set-up fees | No set-up fee; free sandbox; pay when live |
Where each fits
If you are running a global registrational trial with several licensed instruments, many languages and a sponsor requirement for provisioned devices, an enterprise eCOA vendor with a full-service model is often the natural choice. Expect longer build timelines and higher costs, and budget for integration with the EDC.
If you are a small or mid-sized sponsor, an academic group or a CRO running several studies, a unified platform usually makes more sense: one build, one audit trail, one vendor, and participant data that sits next to site data without transfers. If your study is a simple, low-risk questionnaire with no regulatory use, a survey tool can be enough, but check the controls first; see Google Forms for clinical research and HIPAA-compliant survey tools.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Capture ePRO
Participants answer on their own phone from a secure link, with no app to install. Diaries and questionnaires follow the study schedule with windows and reminders, and every answer lands in the same field-level audit trail as site-entered data.
At-risk participants
Free sandbox with every feature, no credit card.
Licensed instruments
Validated questionnaires were usually developed on paper. Moving them to a phone or tablet can change how people answer, so good practice recommendations (notably from ISPOR task forces) grade the changes: minor changes such as layout adjustments usually need little more than a check; moderate changes, such as splitting items across screens or changing response formats, may need cognitive interviewing or usability testing; substantial changes may need full psychometric evaluation.
Many instrument developers also publish their own rules for electronic versions, and licences often require approval of screenshots before use. When comparing ePRO systems, ask how each handles this: whether the vendor has already migrated the instrument, who obtains approval, and how licence details are tracked.
Evaluating a shortlist
Not a vendor-prepared demo.
From a link, on the device participants will use.
Miss an entry and see what happens.
Change an answer and read the record.
Look at the codes, labels and timestamps.
Set-up, licences, per-participant and per-site costs.
It depends on the study. Enterprise eCOA vendors suit large global trials with licensed instruments; unified EDC and ePRO platforms suit most small and mid-sized studies; survey tools suit simple, low-risk questionnaires.
ePRO covers patient-reported outcomes. eCOA also includes clinician, observer and performance outcomes.
BYOD is widely used. Consider measurement equivalence for licensed instruments and follow developers' guidance on electronic versions.
One audit trail, no data transfers or reconciliation, and participant data next to site data.
Yes. The free sandbox has every feature.
Build a diary in the free sandbox today.