Built Locally.TrustedGlobally.
Dual compliance with FDA's 21 CFR-11 & EU's Annexure 11. Deployed across 65+ countries.
100,000+
Users
65+
Countries
3M+
Visits
450+
Research Centres
From paper to platform.
Paper.
Form-by-form, signature-by-signature. Decades of clinical research bound to paper, fax and binders. Slow. Error-prone. Difficult to audit.
Digitised.
Every field, every signature, every audit point — captured electronically. Real-time validation. Queries traced. Submissions cleaner.
Unified.
One platform across CTMS, EDC and PV. A single data model. One audit trail. One sign-on across every site, every country, every phase.
Compliant.
Engineered from day one for the world's strictest regulatory frameworks — FDA 21 CFR Part 11 and EU Annex 11.
Three platforms.
One ecosystem.
Clinical Trial Management, Electronic Data Capture and Pharmacovigilance — one unified data model, one audit trail, one sign-on across every site and country.
Kronus.
The operational backbone of every trial.
One platform for people, documents, training, sites and timelines — under one audit-ready roof.
Explore KronusNukleus.
Streamline your clinical data collection.
A hybrid, secure platform that functions as eSource, EDC or PSP — eliminating data transcription and dramatically improving accuracy.
Explore NukleusSafetyBase.
Adverse-event reporting, signal detection, peace of mind.
A web-based pharmacovigilance platform that streamlines safety data gathering during clinical trials and post-market surveillance.
Explore SafetyBaseOne ecosystem, step by step.
Setup.
Site recruitment, investigator CVs, protocol design and document management.
Run.
Real-time data capture across decentralised sites. ePRO, IWRS, lab module.
Monitor.
AE reporting, signal detection and risk dashboards. Site through to sponsor.
Report.
Regulatory submissions, audit trail, query closure and study close-out.
One data model. One audit trail. One sign-on. Whether you deploy one platform or the full stack, the data flows cleanly across every phase.
A decade.Five continents.One platform.
100,000+
Users
65+
Countries
3M+
Visits
450+
Research Centres
Bring your protocol. We'll show you the fit.
From brief to go-live.
Identify.
Discovery — protocol, sites, sponsors, regulators.
Configure.
Customised stack via our no-code front-end interface.
Deploy.
Launch with full regulatory cover.
Support.
Continuous SLA-backed partnership.
Disruptive Innovation.
Simplified.
See Kronus, Nukleus and SafetyBase in a 30-minute working session, tailored to your trial and your regulatory landscape.