Clinical Trials

The Problem

Clinical trials are a $50+ billion global industry, yet the integrity, transparency, and traceability of trial data remain among the top causes of cost overruns and regulatory delays. Industry estimates show that 80% of trials experience delays, and nearly one-third of FDA rejections cite data inconsistencies or protocol deviations as major issues.

Core challenges include:

• Fragmented data sources (e.g., EDC systems, paper CRFs, labs, wearables) that lack unified traceability

• Manual processes that introduce human error, especially during source data verification (SDV)

• Editable records and weak audit trails, undermining data reliability in regulator inspections

• Retrospective data cleaning and reconciliation can take weeks or months, often just before submission

• Regulatory compliance overhead consumes 25–35% of total trial cost

In particular, retrospective studies, which depend heavily on historical EHRs, lab reports, and previously collected patient data, can take 12 to 18 months to reconcile and verify. For mid-size CROs, this often adds $1–2 million in labor costs and project delays per study. Missing metadata, inconsistent timestamps, and unverifiable provenance can delay or invalidate entire submissions.

This is not just a technical bottleneck, it's a clinical and reputational risk. Unverifiable data can derail approvals, erode patient trust, and force costly re-submissions.

Circular's Solution

Circular Protocol transforms clinical trial data into certified, tamper-proof digital assets from day one.

Key capabilities include:

• Certify data at the source: All CRFs, digital entries, lab files, and endpoint logs are hashed and registered immutably at time of creation

• Full provenance tracking: Investigators, study sites, and CROs are cryptographically attributed to every action, correction, or entry

• Smart signatures and access logs: Built-in compliance with 21 CFR Part 11, ICH GCP E6(R3), and EMA Annex 11

• Real-time audit logs: Sponsors and monitors can review version histories and validations without delays or rework

• Seamless integration: Circular plugs into existing EDC, eTMF, and site platforms via lightweight APIs or browser extensions

Unlike traditional tools, Circular uses decentralized infrastructure to ensure every certified data point is immutable, time-stamped, and regulator-verifiable. This allows sponsors and CROs to maintain audit-readiness from day one, no more scrambling before submission.

This architecture supports both prospective and retrospective trials, enabling organizations to certify imported datasets from historical sources, ensuring integrity even in post-hoc analyses or real-world evidence studies.

How It Works (An Example Flow)

1. Investigator enters CRF data at a study site

2. Circular hashes and timestamps it in real time, capturing metadata and user attribution

3. Site monitor reviews a certified, synced dataset across global sites

4. Sponsor exports a submission-ready package with embedded provenance logs

Outcomes

• Accelerates trial closeout and submission prep by reducing or eliminating retrospective data reconciliation

• Cuts regulatory review time by up to 50%, thanks to embedded audit trails and verifiable data lineage

• Reduces compliance cost by 20–30% by automating documentation and SDV workflows

• Improves approval rates by giving regulators trusted, timestamped, and immutable data

• Enables parallel site expansion and faster interim analysis through a synchronized, certified dataset across geographies

Benefits by Stakeholder

• CROs: Reduced SDV load, lower operational overhead

• Sponsors: Faster time-to-approval, higher data confidence

• Regulators: Transparent auditability with immutable logs

• Patients: Safer, faster access to new treatments with verified outcomes

Circular gives the entire trial ecosystem what it needs most: trust at the data layer, without replacing existing tools or workflows.