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.
One Platform. Three Connected Engines.
Three powerful engines. One unified philosophy. Designed for global data sovereignty, strict compliance, and user-centricity.
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.
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.
/epro) with camera QR-code auto-login, windowed collection schedules, and unified patient audit attribution without third-party app installations.
Clear eTMF
Centralised Trial Master File management. Track essential regulatory documents, versioning, and site-level completeness across every study, with built-in audit trails.
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.
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.
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.
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.
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.
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.
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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.