Clinical research software and a niche CRO

Every stage of clinical research, connected.

KLINiSOL builds the tools that carry a study from its first question to its published results: πHUB for the researcher planning and writing, ILO for the team running the trial.

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ILO: AI extracts the study design from your protocol. Your team reviews every step. ⤢ Click to enlarge

The research lifecycle

QuestionLiterature and evidence
DesignProtocol and sample size
FundingGrant application
BuildeCRF and study setup
ConductSites, data, safety
PublishManuscript and reporting
πHUB plans and funds the study
ILO runs the trial
πHUB publishes

How ILO is built

  • Designed for 21 CFR Part 11
  • ICH-GCP E6(R3)-aligned processes
  • Full audit trails
  • AI-assisted, researcher-approved

Platforms

Two platforms. One intelligent ecosystem.

For researchers

πHUB

A workbench for researchers
Piloting with university researchers

Less time on paperwork, more time on science. Take your research from first question to final manuscript, with ILO, an AI assistant you can talk to, conversant with your own documents.

  • Search and screen the literature
  • Plan your study and draft your protocol
  • Build your grant and write your manuscript
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For sites, CROs and sponsors

ILO

Integrate · Learn · Operate
Pilot deployments 2026

One clinical trial operating system: the AI-native platform that helps teams plan, run and complete studies faster, with less complexity.

  • Protocol to eCRF, with AI-assisted build
  • Study management, ePRO and eCOA
  • Safety, data and eTMF in one place
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Niche CRO

Hands-on support for every study, powered by ILO.

When your study needs people as well as software, our CRO team runs it with you, from protocol to close-out, for investigator-initiated trials and sponsor studies alike.

Protocol developmentStudy design and regulatory strategy
Regulatory affairsIND and IDE submissions, IRB management
Site managementSelection, initiation and monitoring
Data managementCapture, cleaning and analysis
Safety monitoringAE and SAE management
Quality assuranceICH-GCP aligned oversight
All services

Free practice courses

KLINiLEARN

The Clinical Research Learning Library

Learn the regulations. Understand the evidence. Test your knowledge.

Explore 10 free, self-paced courses, from GCP, INDs and device studies to data integrity, human subjects protection, real-world evidence and endpoints in dermatology, cardiology, oncology and gastroenterology. Read the primary sources, watch the video lectures, practice, and earn a certificate of completion for each course.

Browse the courses Start with GCP

Self-paced practice. Not a professional certification.

10free courses
self-paced
62modules
with readings
620questions
tied to sources

Why KLINiSOL

Built by clinicians and clinical researchers, for the people who do research.

Research experienceDesigned by people who have run studies, not only built software.
Built for complianceDesigned for 21 CFR Part 11 and ICH-GCP, with full audit trails.
AI-assisted, researcher-ledAI supports the work; people review and approve every output.

For sites, CROs and sponsors

See ILO in action.

A 30-minute walkthrough of ILO on a study like yours, from protocol to eCRF.

Request a demo Talk about your study

KLINiLEARN

Train your team, free.

10 self-paced practice courses on GCP, INDs, data integrity and more.

Browse the courses