The Problem Approach e-Delegate Developers About
Open-Source · ICH GCP · 21 CFR Part 11 Ready
Truth in Every Trial

Clinical Trials Built on
Truth, Designed for People.

Nokware Research Solutions delivers purpose-built clinical trial technology rooted in equity, transparency, and open science — so every trial runs with integrity and every participant matters.

ICH GCP Compliant 21 CFR Part 11 Ready 100% Open Source
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0
Years in Clinical Research
Phase I–IV
Trial Expertise
0
Therapeutic Areas
0
Open Source

Clinical Research Is Broken in Plain Sight.

The systems that power clinical trials were not built for the people they affect most. It's time for a fundamental rethink.

Exclusionary Design

Trial platforms assume English fluency, tech literacy, and urban proximity — systematically excluding the communities most affected by disease.

Access Barriers Language Gaps

Fragmented Compliance

Paper binders, siloed spreadsheets, and manual audit trails create compliance nightmares — risking patient safety and data integrity.

Paper Binders Siloed Data

Opacity Over Trust

Black-box EDC systems and vendor lock-in make it impossible for sites to verify, audit, or truly own their own trial data.

Black-box EDC Vendor Lock-in

"Clinical trials must earn trust — from participants, regulators, and the public. That trust starts with technology that is transparent by design."

Equity-First. Open by Default. Built to Last.

01

Participant-Centered by Architecture

Consent workflows designed for comprehension, not just signature capture. Multi-language support, remote participation pathways, and accessibility-first design.

  • Comprehension-first informed consent
  • Multi-language & accessibility-first
  • Remote participation pathways
02

Compliance Without Compromise

Every feature is designed with ICH GCP E6(R2) and 21 CFR Part 11 in mind from day one — not bolted on after the fact.

  • ICH GCP E6(R2) from day one
  • 21 CFR Part 11 electronic records
  • FDA inspection-ready audit trails
03

Open by Default

MIT-licensed, publicly auditable, community-driven. No black boxes. No vendor lock-in. Full data sovereignty for every site.

  • MIT-licensed, forever open
  • Publicly auditable codebase
  • Full data sovereignty for sites
04

Built by People Who've Done It

Founded and built by a Senior CRA with 14+ years across Phase I–IV trials in oncology, ophthalmology, immunology, and more.

  • 14+ years of real-world trial experience
  • Multiple therapeutic areas
  • Practitioner-first design philosophy

One Platform. Every Delegation Workflow.

The open-source electronic delegation log that replaces paper binders, siloed spreadsheets, and fragmented email threads.

e-Delegate is live
Production-ready delegation management for clinical sites

Electronic Delegation Log

Digitize the entire delegation workflow — from task assignment to PI sign-off — with a system purpose-built for clinical trial sites.

  • Role-based task delegation per protocol
  • Date-bound delegation periods with versioning
  • PI review and electronic approval workflows
  • Real-time status tracking across personnel
Delegation Log — PROT-2026-001
JD
Dr. Jane Doe
Informed Consent · Sub-Investigator
Active
MS
Mark Smith, RN
Vitals Collection · Study Coordinator
Pending Review

E-Signatures (21 CFR Part 11)

Compliant electronic signatures that meet federal requirements for electronic records — no wet ink needed.

  • Intent-based signing with unique credentials
  • Timestamped, non-repudiable signature records
  • Meaning-of-signature manifests per signer
  • Linked to complete audit trail

Personnel & Training Tracker

Track team members, roles, qualifications, and training status across protocols in a single unified view.

  • CV and credentials management
  • Training log with completion tracking
  • Role-based access control

Real-Time Dashboard

At-a-glance visibility into delegation status, pending actions, expiring tasks, and team readiness.

  • Protocol-level summary metrics
  • Delegation coverage heat map
  • Pending action notifications

Immutable Audit Trail

Every action logged — who, what, when, and why. Designed for FDA inspection readiness from day one.

  • Tamper-evident chronological records
  • Reason-for-change logging
  • Export-ready for regulatory review

Multi-Protocol Support

Manage delegation logs across multiple active protocols simultaneously — without duplication or confusion.

  • Protocol-specific delegation views
  • Cross-protocol personnel overview
  • Unified training requirements
app.nokware-research.org/dashboard
Active
24
Pending
7
Expiring
3
Revoked
1
PersonnelTaskStatus
Dr. A. PatelInformed ConsentActive
M. Johnson, RNLab CollectionPending
T. WilliamsIP DispensingActive
ICH GCP E6(R2) 21 CFR Part 11 FDA Inspection Ready MIT License

Built in Public. Open Forever.

nokware-research/e-delegate
Open-source electronic delegation log for clinical trials
TypeScript MIT License
View on GitHub →
git clone https://github.com/nokware-research/e-delegate.git

Tech Stack

React 18 TS TypeScript Vite TanStack Query React Router v6 N Node.js PG PostgreSQL Tailwind CSS GitHub Actions CI MIT License

Join the mission.

Nokware is built in public. We welcome contributors — developers, clinical researchers, designers, and advocates — who believe clinical trial technology should be open, equitable, and transparent.

KQ

Kojo A. Quansah Jr., PharmD

Senior CRA · Site Director · Founder

  • 14+ years of Phase I–IV clinical research experience
  • Oncology, Ophthalmology, Immunology, ID, Neuro
  • GCP / ICH / FDA regulatory expertise
  • Open Science Advocate

Clinical research technology should be as diverse as the patients it serves.

Nokware was founded on the belief that clinical trial infrastructure must reflect the diversity, dignity, and rights of every participant. When the tools are transparent, the science earns trust. When the technology is open, innovation is shared. When design centers equity, outcomes improve for everyone.

What Does "Nokware" Mean?

"Nokware" (pronounced noh-KWA-ray) is the Akan/Twi word for Truth — the same truth that anchors every clinical trial, every participant relationship, and every line of code we write. The name is a daily commitment: to build technology that is honest, transparent, and worthy of trust.

Equity
Transparency
Open Science
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