Get Access to Clear EDC

Empowering Clinical
Research.

Accelerate database lock, streamline query resolution, and ensure continuous inspection readiness. Clear EDC delivers dependable trial execution across complex multi-centre protocols.

ICH GCP E6(R2) Aligned
CDISC ODM & SDTM Native
21 CFR Part 11 Aligned
UK / EU Data Residency
Regulatory Heritage

Good clinical data practice started as method and law, long before it was software.

Among the earliest milestones: the UK Medical Research Council's 1948 streptomycin trial, designed by Austin Bradford Hill and widely credited as one of the first modern randomised controlled trials, and the US Kefauver–Harris Amendments of 1962, which made evidence from “adequate and well-controlled investigations” a legal requirement. Neither was the whole story, but both shaped the discipline of structured, auditable trial data. We built Clear EDC to honour that history while building the tools the next generation of trials will need.

Platform Architecture

One Platform. Three Connected Engines.

Three powerful engines. One unified philosophy. Designed for global data sovereignty, strict compliance, and user-centricity.

Study
Data Capture
Validation
Review
Clean Data

Clear EDC

A scalable, unified clinical data architecture delivering an inspection-ready trial environment. Configure complex adaptive protocols with native capabilities, eliminating external dependencies while maintaining strict sovereign cloud residency.

Data Integrity & Part 11 Compliance: 21 CFR Part 11 and ICH GCP compliant with immutable append-only audit trails, cryptographic dual-factor electronic signatures, reason-for-change gates, and automated living GAMP 5 validation with zero-defect release gates.
Instant SDTM Export & CDASH Scaffolding: Automated, submission-ready CDISC SDTM CSV packages (DM, VS, AE, CM, MH, DS) with derived study days (--DY), out-of-the-box CDASHIG v2.2 standard eCRF templates, and direct NCI EVS controlled terminology import.
Interventional IWRS & Emergency Unblinding: Native double-blind randomization with stratified slot allocation, blinded kit dispensing, and 21 CFR §312.62 emergency code-break with dual-factor signature and audit trail blind concealment.
Real-Time Operational Monitoring: Interactive study dashboards with recruitment funnels, query turnaround aging buckets (5d, 14d, 30d), visit completeness metrics, and sortable site performance league tables with bookmarkable deep-link filtering.
Frictionless Patient ePRO: Native mobile participant portal (/epro) with camera QR-code auto-login, windowed collection schedules, and unified patient audit attribution without third-party app installations.
Roadmap

Clear eTMF

Centralised Trial Master File management. Track essential regulatory documents, versioning, and site-level completeness across every study, with built-in audit trails.

Roadmap

Clear CTMS

Complete operational oversight. Manage sites, monitoring visits, and payments in one synchronised dashboard tailored for complex, multi-centre global trials.

Modern, API-First Architecture

Natively integrated, not third-party stitching. A documented OpenAPI REST API sits behind every screen, so your statisticians and data managers can connect the tools they already use on day one.

React TypeScript ASP.NET Core SQL Server Azure OpenAPI REST

Data Integrity

Single source of truth for clean, reliable data.

Explicit Workflows

Unambiguous processes mapped to real-world operations.

Historical Preservation

Complete audit trails and unalterable records.

Tenant Isolation

Secure, compartmentalised data architecture.

Reviewable Changes

Transparent modification history with accountability.

CDISC ODM Data Model — Full Amendment Trace

Simplified for illustration — the full CDISC ODM standard also defines an ItemGroup layer between Form and Item.

Study
Version
Event
Form
Item
Data Point

AI-Assisted Drafting is draft-only by design: every suggestion needs a human reviewer and a named attribution before it can become part of the record. It drafts; it never decides.

Clear EDC is engineered to support ICH GCP, 21 CFR Part 11 and GDPR-aligned workflows. It is not automatically compliant — formal validation depends on your own configuration, SOPs and validation documentation.

Event Recap

Missed Us at ICTMC 2026?

Clear Clinical Solutions attended the 8th International Clinical Trials Methodology Conference this September, meeting trial teams, statisticians, and data managers from across the sector. If we didn’t connect there, get in touch now — and look out for our next event.

14-17 September 2026
The ICC, Birmingham, UK
Expert Consultancy Services

Clinical Trial Lifecycle Support

Software alone doesn't lock a database. Clear Clinical Solutions provides specialised operational expertise across the trial lifecycle — from initial eCRF design to final database lock — working alongside your team, not instead of it.

Study Design

eCRF architecture & protocol mapping before protocols harden.

Validation & UAT

IQ/OQ/PQ evidence and regression testing for mid-trial change.

Database Lock

Cleaning surges, legacy migrations, and pre-lock audits.

A small group reviewing documentation together A researcher using a pipette over a tray of ice in a laboratory Clinicians reviewing radiographs together on a lightbox
Collaboration

Strategic Advisory & Early Access Programme

We are partnering with forward-thinking clinical operations leaders, CTUs, and biopharma sponsors. Test protocol configurations in our secure, synthetic-data sandbox to validate platform capabilities against your specific study requirements.

Priority Sandbox Access

Gain advance access to platform release candidates and isolated sandbox validation environments.

Protocol Co-Design

Directly influence feature architecture, eCRF logic workflows, and the strategic product roadmap.

Preferential Commercial Terms

Advisory partners lock in guaranteed founder commercial terms, at-cost data migration, and priority SLAs.

Request Strategic Partnership Access

Partner cohorts now open for Q4 2026 and Q1 2027 commercial trial onboarding.

Clinicians reviewing radiographs together on a lightbox A researcher using a pipette over a tray of ice in a laboratory A small group reviewing documentation together

What counts as good evidence hasn't changed. We just want it easier to produce.

Good evidence has always meant trials that are well run and carefully controlled. Clear EDC makes this easier to show and prove — in any country.

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