# 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.
