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.
The systems that power clinical trials were not built for the people they affect most. It's time for a fundamental rethink.
Underrepresented communities are systematically excluded from clinical research through structural barriers — inaccessible consent forms, English-only platforms, and site-centric models that ignore real-world constraints.
Delegation logs live in paper binders. Training records sit in siloed spreadsheets. Protocol amendments get lost between email threads. This fragmentation slows FDA submissions and invites costly audit findings.
Black-box proprietary EDC platforms lock researchers into vendor ecosystems, obscure data models, and make independent auditing nearly impossible — eroding the trust that ethical research depends on.
"Clinical trials must earn trust — from participants, regulators, and the public. That trust starts with technology that is transparent by design."
— Nokware Research Solutions
We don't retrofit ethics onto finished software. We architect for equity, compliance, and transparency from the first line of code.
Consent workflows designed for comprehension, not just signature capture. Multi-language support, remote participation pathways, and accessibility-first interfaces ensure every participant is respected.
ICH GCP E6(R2) and 21 CFR Part 11 aren't afterthoughts — they are structural principles. Electronic signatures, audit trails, and role-based access are built into the foundation, not bolted on.
Public source code. Documented data models. Auditable decision logic. Every design choice is visible, reviewable, and accountable — because trust is earned through openness, not marketing.
MIT licensed. No vendor lock-in. No per-seat pricing that prices out under-resourced institutions. Global research teams deserve tools they can inspect, modify, and own — forever.
"To make clinical research more equitable, more trustworthy, and more efficient by building open-source technology that centers the human beings at the heart of every trial — and gives the research community tools they can actually own."
The open-source delegation management system built to replace paper binders with structured, auditable, regulation-ready electronic records.
Versioned electronic records capturing who, what, when, and which protocol — eliminating paper trail ambiguity.
Identity verification, meaning-of-signature capture, and tamper-evident records meeting FDA electronic signature requirements.
Granular permissions for PIs, sub-investigators, coordinators, monitors, and sponsors — each sees only what they should.
Personnel certifications and training records linked directly to delegation entries, keeping compliance current and auditable.
Every action logged with timestamp, user identity, and change delta — producing an FDA-ready audit trail from day one.
Manage multiple protocols per site with version-controlled amendments, so your delegation records scale with your research.
Every feature in e-Delegate is designed around the regulatory frameworks that govern clinical research.
This isn't open-washing. Our source code, roadmap, and decision-making are public. This is an open invitation to build better clinical trial infrastructure together.
github.com/nokware-research/e-delegate
The complete e-Delegate platform — delegation log management, electronic signatures, audit trails, and role-based access. Built with React 18, TypeScript, and Node.js — designed for research sites of any size.
View RepositoryEveryone is welcome
Whether you write code, design interfaces, understand clinical operations, or navigate regulatory frameworks — there's a place for you here.
Tech Stack
Nokware was founded on a simple belief: the tools that power clinical research should be as ethical as the research itself.
Senior Clinical Research Associate · Founder, Nokware Research Solutions
With over 14 years driving Phase I–IV clinical trials across oncology, ophthalmology, immunology, infectious disease, and neuroscience, Kojo brings frontline site expertise — from ICH/GCP compliance and 21 CFR audit readiness to field-based monitoring across extensive territories using Veeva Vault CTMS. A primary site liaison who builds trusted investigator relationships and proactively manages recruitment, quality, and risk, he is equally fluent in AI-assisted workflows, including co-designing an AI agent that automated CRA monitoring processes. He founded Nokware Research Solutions to translate that experience into open-source tools that make clinical research faster, more equitable, and more compliant — beginning with e-Delegate, an inspection-ready delegation log platform he designed to replace paper-based processes with audit-traceable electronic records aligned to ICH/GCP delegation-of-authority requirements.
We build for the communities most harmed by extractive research practices — ensuring technology serves participants, not just sponsors.
ICH GCP and 21 CFR Part 11 compliance isn't a checkbox for us — it's the architecture. Regulatory readiness is a design constraint, not a post-launch patch.
MIT Licensed, publicly auditable, and community-governed. We believe transparency is the foundation of trust in clinical research technology.
Whether you're a research site, a sponsor, or a fellow builder — we'd love to hear from you. Let's make clinical trials work for everyone.