Clinical Research

Accelerate Trials.
Protect Patients.

GCP/GLP-compliant LIMS purpose-built for clinical trial laboratories, central labs, and biorepositories.

I
Safety & PK20–100 subjects
II
Efficacy100–500 subjects
III
Confirmatory1K–5K subjects
IV
Post-MarketVaries subjects
Image: Clinical Lab
50K+Subjects Tracked
200+Clinical Sites
< 24hrResult Delivery
ZeroData Breaches

How We Handle Clinical Samples

Image: Kit Preparation & Shipment
01
Step 01

Kit Preparation & Shipment

Pre-labeled sample kits with barcoded tubes, requisition forms, and temperature loggers shipped to every clinical site.

Image: Site Collection & Chain-of-Custody
02
Step 02

Site Collection & Chain-of-Custody

Site coordinators collect samples per protocol visit schedule. Every handoff logged with timestamps and digital signatures.

Image: Central Lab Processing
03
Step 03

Central Lab Processing

Samples received, accessioned, aliquoted, and routed to analyzers. Real-time status visible to sponsors and monitors.

Image: Result Delivery & Query Resolution
04
Step 04

Result Delivery & Query Resolution

Results transmitted electronically to EDC systems within SLA. Automated query generation for out-of-range or missing values.

Purpose-Built For Clinical Labs

Image: Subject Dashboard
Subject Management

Complete Subject Lifecycle

From screening through follow-up — track every subject's visit schedule, sample inventory, consent status, and demographic data in one place. Automated visit window calculations flag protocol deviations in real time.

Randomization code management
Visit window calculations
Consent tracking with version control
Unblinding workflow controls
Image: Safety Alerts
Safety Labs

Rapid Safety Lab Turnaround

Hematology, clinical chemistry, urinalysis, and coagulation panels processed with automated delta checks, reference range flagging, and clinically significant result alerts sent directly to investigators.

Automated delta & panic value alerts
Reference range by age/sex/ethnicity
Direct investigator notification
Integration with safety database
Image: Sample Storage Map
Biorepository

Long-Term Sample Banking

Manage millions of archived samples with precise -80°C / LN₂ location tracking, consent-linked retrieval workflows, and automated expiry management. Never lose a sample.

Rack/box/position level tracking
Temperature excursion monitoring
Consent-based access controls
Retrieval request workflow

ALCOA+ Data Integrity.
Built Into Every Record.

Attributable. Legible. Contemporaneous. Original. Accurate. Complete. Consistent. Enduring. Available.

Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Consistent
Enduring
Available
21 CFR Part 11
Image: Global Site Map

200+ Sites. One Platform.

Coordinate sample logistics across clinical sites worldwide — kit shipment tracking, courier management, and chain-of-custody from collection to central lab.

  • Pre-labeled kit management per protocol
  • Courier integration with real-time tracking
  • Temperature-monitored shipments with alerts
  • Multi-timezone visit window management
  • Site performance dashboards for sponsors

Regulatory Compliance

ICH GCP (E6 R2)
FDA 21 CFR Part 11
EMA Guidelines
GLP (OECD)
CDSCO
ISO 17025
NABL
HIPAA
GDPR
CAP / CLIA

From Bench To Bedside.

The LIMS trusted by clinical research labs to deliver regulatory-grade data.