EDC for Phase 2 Clinical Trials

EDC for Phase 2 trials: efficacy, safety, and multi-site support in one platform with 21 CFR Part 11–aligned controls and CDISC-ready export.

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

How Phase 2 teams use Capture.Study day to day

In a Phase 2 study on Capture, investigators and coordinators see a visit- and participant-centric view of the trial: they log in, see which visits and assessments are due, capture data in configured CRFs, and respond to queries raised by monitors or data managers. Monitors work from the same underlying dataset, focusing on source data verification, query workflows, and site-level performance. Data managers and statisticians rely on consistent exports that match the structures they use for analysis and regulatory submissions.

  • Site staff access the study via a browser-based interface with visit schedules and participant overviews that mirror how they work in clinic
  • Monitors raise, assign, and resolve queries inside Capture, with full audit history, instead of emailing spreadsheets back and forth
  • Data managers use dashboards to check enrollment, data completeness, and open queries across all sites
  • Biostatistics and programming teams pull CDISC-aligned exports from the same platform that sites use to enter data

Connecting Phase 2 operations to Capture modules

The same modules described elsewhere on the Capture.Study site—EDC, eConsent, ePRO, and safety—are the building blocks for Phase 2 trials. For each protocol, you decide which modules to enable: traditional clinic visits captured via CRFs, optional ePRO for patient-reported outcomes, electronic consent for new or amended forms, and safety workflows for AEs and SAEs. Because everything is configured rather than custom-coded, your team can reapply successful Phase 2 configurations across related programs while still tailoring details for each indication or region.

  • Use eConsent when Phase 2 protocols call for electronic consent or re-consent after amendments; otherwise keep consent on your existing processes
  • Turn on ePRO/eCOA only when you have protocol-defined questionnaires or diaries
  • Configure randomization and visit schedules so that allocation, dosing, and assessments are captured in one system
  • Reuse core Phase 2 designs (CRFs, visits, roles) across studies while adjusting endpoints and schedules per protocol

Overview

EDC for Phase 2 Clinical Trials

Phase 2 clinical trials evaluate efficacy and safety in the target population. They often involve more sites and participants than Phase 1, with stronger emphasis on efficacy endpoints, randomization, and sometimes patient-reported outcomes. Operationally, Phase 2 is where many teams first feel the friction of coordinating multiple sites, visit schedules, assessments, and monitoring activities in parallel, while still needing to keep timelines and budgets under control. Study teams need to monitor enrollment, data completeness, protocol deviations, and emerging safety or efficacy trends across sites—typically with lean internal staff and fixed timelines driven by portfolio decisions. Your EDC must support multi-site workflows, ePRO and eCOA when required, source data verification and query management, and regulatory-ready data export—without Phase 3–scale cost and implementation. It also needs to integrate into your existing ways of working: configuration and validation flows that match your SOPs, exports that map cleanly into your CDISC and programming pipelines, and user experiences that site staff can adopt without months of training. Capture provides a unified EDC with eConsent, ePRO, and CRFs in one platform, with 21 CFR Part 11–aligned controls and HIPAA-aligned security, so Phase 2 teams can run multi-site trials with one system and export that supports analysis and regulatory submissions, instead of stitching together data from separate vendors.

Why Phase 2 is different

Phase 2 studies are larger and more complex than Phase 1 but typically don’t need the full scope of a global Phase 3 EDC. You need solid multi-site support with role-based access and per-site visibility, efficacy and safety capture, ePRO when the protocol requires it, SDV and query workflows, and export that supports analysis and regulatory submissions. Training and support should be manageable for site staff without the overhead of enterprise-level implementations.

Common Phase 2 workflow

  • Protocol with efficacy and safety endpoints; multi-site selection and activation
  • Screening, consent, and randomization with allocation logged and auditable
  • Baseline and on-treatment visits; visit windows and compliance tracking
  • ePRO and clinician-assessed outcomes (eCOA) when required by protocol
  • Safety and adverse event capture with severity, causality, and follow-up
  • Source data verification (SDV) and query management with full audit history
  • Centralized monitoring and per-site enrollment and data visibility
  • Database lock and export for analysis; CDISC-compatible structures for regulatory use

Traditional tool pain points

  • Enterprise EDC pricing and long contracts for mid-size Phase 2 that don’t fit budget
  • Separate ePRO and EDC systems that don’t talk to each other or share one audit trail
  • Slow protocol amendments and change control when the protocol evolves
  • Heavy training and support for site staff and complex site-facing tools
  • Per-site or per-seat fees that scale poorly for Phase 2 size
  • Limited or costly export options for CDISC and regulatory submissions
  • Fragmented reporting that makes it hard to monitor enrollment and data quality across sites

How Capture supports Phase 2

  • Unified EDC with eConsent, ePRO, and CRFs so sites use one system and one audit trail
  • Multi-site support with role-based access, per-site enrollment and data visibility, and centralized monitoring
  • Randomization and visit-based data capture for efficacy and safety
  • SDV and query workflows with full audit trail; queries raised, assigned, and resolved in platform
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security for participant data
  • Export for analysis and regulatory use; structures designed with CDISC CDASH and SDTM in mind
  • Documentation and support for sponsor validation and UAT (Enterprise) when required
  • Configurable dashboards and filters to track enrollment, data completeness, and key endpoints across sites

Related

Clinical trial softwareAffordable EDC for clinical trialsEDC with built-in ePRO

FAQ

Questions we hear a lot

Can Capture support multi-site Phase 2 trials?
Yes. Capture supports multiple sites with role-based access, per-site enrollment and data visibility, and centralized monitoring. You get one platform for EDC, eConsent, and ePRO across all sites, with one audit trail and one study build.
Do you support ePRO and patient-reported outcomes?
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.
What about SDV and monitoring?
Capture includes workflows for source data verification and query management. Queries can be raised, assigned, and resolved with full audit history. This supports monitoring and inspection readiness for Phase 2 studies. All activity is traceable in the audit trail.
Can we export for regulatory submissions?
Yes. Data can be exported in formats suitable for analysis and regulatory submissions. Structures are designed with CDISC CDASH and SDTM mapping in mind. We provide documentation to support sponsor validation where required (Enterprise).
How does Capture handle randomization for Phase 2?
Capture includes configurable randomization (e.g., block, stratified) so you can support randomized Phase 2 designs. Allocation is logged and auditable. You can manage multiple arms and treatment groups within the same study build.
Can we give different teams different levels of access?
Yes. Role-based access lets you configure separate views and permissions for site staff, monitors, data managers, and sponsors. This supports multi-site Phase 2 trials while keeping access aligned with your governance model.
Does Capture support stratification factors for Phase 2 randomization?
Yes. You can configure stratified randomization to account for key factors such as site, baseline disease severity, or other protocol-defined strata, while keeping allocation logs auditable.
How do we handle mid-study protocol changes in Phase 2?
You can update CRFs, visit schedules, and logic in accordance with your change-control process. Capture records these changes in the audit trail and supports documenting which participants or visits are affected.
Can monitors filter by site or country when reviewing Phase 2 data?
Yes. Data can be filtered or exported by site, region, or other attributes so monitors and data managers can focus on the subset of data relevant to their role.
How does Capture fit with our CDISC and programming workflows?
Capture’s export structures are designed with CDISC CDASH and SDTM mapping in mind. Programming teams can build on those exports within their existing toolchains, and for Enterprise implementations we provide documentation to support alignment with your internal standards.

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