ePRO Platforms for Early-Stage Biotech

ePRO platforms for early-stage biotech: patient-reported outcomes with 21 CFR Part 11–compliant controls. Speed, flexibility, no enterprise overhead.

21 CFR Part 11 compliant · HIPAA-compliant security · No credit card required

  • ISO 27001 certified
  • 21 CFR Part 11 compliant
  • GDPR compliant
  • EU and US data hosting
  • HIPAA compliant
  • ICH GCP E6(R3) compliant
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Overview

ePRO Platforms for Early-Stage Biotech

ePRO platforms for early-stage biotech need to emphasize speed, flexibility, and avoiding enterprise implementation overhead—patient-reported outcomes with 21 CFR Part 11–compliant controls and one audit trail when integrated with EDC and eConsent. Early-stage biotech often has tight timelines and lean teams; they need one platform without enterprise ePRO minimums or long implementation. Paper and app fragmentation cause issues. Capture provides ePRO in the same platform as EDC and eConsent—one audit trail, rapid build, built for early-stage biotech.

Why early-stage biotech wants ePRO platforms

Early-stage biotech needs participant-reported data with full audit trail and 21 CFR Part 11–compliant controls—with speed, flexibility, and no enterprise implementation overhead. When ePRO is in the same platform as EDC and eConsent, you get one build and one audit trail; when it’s separate, you get integration cost and two audit trails.

Common ePRO workflows for early-stage biotech

  • Rapid configuration and deployment; no enterprise implementation overhead
  • Schedule PRO instruments by visit or time window; same platform as CRFs and consent
  • Same 21 CFR Part 11–compliant controls and HIPAA-compliant security as EDC and eConsent
  • Pricing and support that scale with early-stage studies
  • Documentation to support sponsor validation when required (Enterprise)

Why paper and app fragmentation cause issues

  • Paper PROs: transcription errors, missing data, no single audit trail
  • Separate ePRO vendor: two systems, two audit trails, enterprise implementation overhead
  • Enterprise ePRO minimums and long implementation for early-stage timelines
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO for early-stage biotech

  • ePRO in same platform as EDC and eConsent; one audit trail; speed and flexibility for early-stage biotech
  • Questionnaires, diaries, and PRO instruments configurable in study builder
  • 21 CFR Part 11–compliant controls and HIPAA-compliant security
  • Documentation for sponsor validation (Enterprise); explore ePRO or book a demo
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FAQ

Questions we hear a lot

What are ePRO platforms for early-stage biotech?
ePRO platforms for early-stage biotech offer patient-reported outcomes with 21 CFR Part 11–compliant controls—with speed, flexibility, and no enterprise implementation overhead. Capture includes ePRO in the same platform as EDC and eConsent, built for early-stage biotech.
Do I need a separate ePRO vendor for early-stage biotech?
No. Capture includes ePRO. You can configure and schedule PRO instruments; data is captured with the same audit trail and security controls as the rest of the study.
Is Capture 21 CFR Part 11–compliant?
Yes. Capture is designed with 21 CFR Part 11–compliant controls and HIPAA-compliant security. We provide documentation to support sponsor validation when required (Enterprise).

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