EDC for Phase 1b Clinical Trials

Electronic data capture for Phase 1b trials: patient cohorts, efficacy signals, and safety in one platform with 21 CFR Part 11–aligned controls.

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

How Phase 1b data flows through Capture.Study

In a Phase 1b study on Capture, consent, randomization (when applicable), CRFs for safety and efficacy, and optional ePRO all live in the same application. Site staff use a web interface that mirrors the patterns you see on the main marketing site—visit lists, participant overviews, and task-oriented forms—while data managers and monitors work from the same underlying dataset with filters and exports suited to their role.

  • Participants are consented via eConsent; their enrollment and randomization status is visible on the same participant profile used for CRFs
  • Safety, efficacy, and biomarker forms are configured as visit-based CRFs so monitors can review data in context
  • Optional ePRO instruments are scheduled alongside clinic visits when the protocol calls for patient-reported outcomes
  • Data managers and statisticians export structured datasets for interim and final analyses without reconciling multiple vendor feeds

Design patterns for multi-arm Phase 1b studies

Because many Phase 1b studies involve multiple arms, dose levels, or combinations, it helps to standardize how you represent arms and cohorts in the EDC. Capture lets you encode treatment arms, randomization strata, and visit schedules in configuration rather than code, and reuse those patterns when you run similar Phase 1b programs across different assets.

  • Represent treatment arms and dose levels explicitly in CRF design so every subject’s allocation is clear
  • Use visit templates to keep safety and efficacy assessments consistent across arms and sites
  • Reuse successful multi-arm configurations for future early-phase protocols with similar designs
  • Keep all arm- and cohort-level decisions traceable through the same audit trails used for other activities

Overview

EDC for Phase 1b Clinical Trials

Phase 1b trials extend Phase 1 into patient populations, often adding early efficacy and biomarker endpoints alongside safety and PK. These studies bridge first-in-human safety data and proof-of-concept, so your EDC must support both safety and efficacy data, potential randomization and multi-arm designs, and the flexibility to adapt as the protocol evolves. In many organizations, Phase 1b is when cross-functional teams—clinical operations, medical, biostatistics, pharmacometrics—begin to rely on the same dataset to make go/no-go decisions, so consistency and traceability across all modules becomes critical. You need one system that can handle consent, CRFs, ePRO when required, safety and AE capture, and export for analysis—without the cost and complexity of a full Phase 2/3 EDC. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned security, so Phase 1b teams can run patient cohorts and early efficacy studies efficiently while keeping data in a single, auditable environment.

Why Phase 1b is different

Phase 1b studies bridge early safety (Phase 1a) and proof-of-concept. They often include patients, multiple arms or doses, and a mix of safety, PK, and efficacy endpoints. You need randomization when the design calls for it, ePRO for patient-reported outcomes, and clear audit trails for all data. Your EDC should handle this without the full complexity of a Phase 2/3 system—no need for hundreds of sites or global supply modules, but you do need solid multi-arm support, role-based access, and export that supports regulatory and analysis needs.

Common Phase 1b workflow

  • Protocol with patient population, efficacy endpoints, and optional randomization
  • Site activation and enrollment; often a small number of sites
  • Screening, consent, and randomization (if applicable) with allocation logged
  • Safety, PK, and efficacy data collection; biomarker and lab data
  • ePRO and patient-reported outcomes when required by protocol
  • Adverse event and concomitant medication capture with full audit trail
  • Interim reviews, DSMB or internal review, and possible protocol updates
  • Query resolution and monitoring across safety, efficacy, and biomarker data
  • Database lock and export for safety and efficacy analysis

Traditional tool pain points

  • Separate systems for EDC, ePRO, and safety that don’t integrate or share one audit trail
  • Slow build and change processes for mid-study updates and protocol amendments
  • Pricing that doesn’t fit small patient cohorts and per-module fees that add up
  • Complex validation and training for lean Phase 1b teams
  • Randomization handled in a different system, complicating allocation and audit
  • Limited flexibility for mixed safety/efficacy and biomarker workflows

How Capture supports Phase 1b

  • EDC, eConsent, ePRO, and safety in one platform so one system supports the full workflow and one audit trail
  • Randomization and multi-arm designs when your protocol requires them; allocation is logged and auditable
  • Flexible forms and visits for safety, efficacy, biomarkers, and ePRO
  • Full audit trails and 21 CFR Part 11–aligned controls: e-signatures, access control, audit history
  • HIPAA-aligned security for participant data and PHI
  • Export for analysis and regulatory submissions; documentation for sponsor validation (Enterprise)

Related

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FAQ

Questions we hear a lot

Can Capture handle Phase 1b patient studies?
Yes. Capture supports studies in patient populations with safety, efficacy, and biomarker data. You can use randomization and multiple arms, and all data is captured with audit trails and access controls suitable for regulatory use. ePRO and patient-reported outcomes can be configured when your protocol requires them.
Do you support randomization?
Yes. Capture includes configurable randomization (e.g., block, stratified) so you can support randomized Phase 1b designs. Allocation is logged and auditable, with full traceability for regulatory review.
How do we ensure data integrity?
Capture provides electronic signatures, comprehensive audit trails, and role-based access. Data export is consistent and traceable. These controls are designed to align with 21 CFR Part 11 expectations for electronic records. For regulated studies we provide documentation to support sponsor validation and UAT.
Can we use ePRO in Phase 1b?
Yes. Capture includes ePRO and eCOA: questionnaires, diaries, and PRO instruments can be configured and scheduled. Data is captured electronically with the same audit and security controls as the rest of the study, so you don’t need a separate ePRO vendor.
Can we run a combined Phase 1b/2 design in Capture?
Yes. You can configure visits, arms, and cohorts to support combined Phase 1b/2 designs, using the same platform for safety, efficacy, biomarker and ePRO data. Many teams extend early-phase builds into proof-of-concept using the same configuration as a starting point.
How are biomarker and lab data handled?
You can configure CRFs to capture biomarker and lab results at the appropriate visits and time points. Those data are stored with full audit history and can be exported alongside other safety and efficacy data for analysis.
Can external labs or vendors access the system?
If your governance model allows, you can grant limited, role-based access to external partners (such as central labs) so they can review or enter data directly. Access and actions are tracked in the audit trail.
Does Capture support blinded and open-label Phase 1b studies?
Yes. You can configure roles so that only certain users have access to treatment allocation information, supporting blinded or partially blinded designs, while still keeping allocation logged and auditable.
How do monitors and DSMBs review Phase 1b data?
Monitors and DSMBs can review safety, efficacy, and biomarker data through exports or read-only access, depending on your processes. Capture’s audit trails and role-based access help you demonstrate who saw what and when.
Can we align Capture with our existing SOPs?
Yes. Sponsors remain responsible for their SOPs; Capture is designed to fit into existing procedures for study build, validation, monitoring, and database lock. We provide documentation to support that alignment for Enterprise implementations.

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