Clinical Research

Clinical Trial Sample Management — Specimen Tracking from Site to Central Lab

LIMSera supports clinical trial central laboratories, biorepositories, and translational research facilities with specimen-centric workflows. Track samples from clinical site collection through shipment, receipt, aliquoting, testing, and long-term storage. Integrate with EDC systems, manage kit building for investigator sites, and maintain full 21 CFR Part 11 / GCP compliance.

Request a Demo
Explore Platform
Challenges

Key Challenges in Clinical Research Laboratories

These are the operational, regulatory, and data-management pain points that labs in this industry face every day.

Managing multi-site specimen logistics with real-time shipment tracking and temperature monitoring

Maintaining blinded sample identity while ensuring accurate test result attribution

Integrating with EDC/CDMS platforms (Medidata Rave, Veeva, Oracle Clinical) for seamless data flow

Building and distributing sample collection kits to investigator sites with visit-specific contents

Handling protocol amendments that change sample collection requirements mid-study

Solutions

How LIMSera Solves Them

Purpose-built features that directly address the challenges your laboratory faces.

Protocol-driven sample collection schedules with visit windows and deviation tracking

Kit building and distribution management with barcode-labeled collection tubes

Blinded and unblinded access modes with role-based data segregation

Specimen receipt workflow with condition assessment, aliquoting, and storage location assignment

Integration APIs for Medidata, Veeva, Oracle Clinical, and custom EDC platforms

Biorepository module with box-position-level storage tracking and retrieval workflows

Parameters

Key Parameters Tested

Comprehensive parameter coverage for clinical research laboratory testing.

Hematology panel — CBC with differential, hemoglobin, hematocrit, platelet countClinical chemistry — liver function (ALT, AST, bilirubin), renal function (creatinine, BUN, eGFR), lipid panel, glucose, HbA1cCoagulation — PT/INR, aPTT, fibrinogen, D-dimerUrinalysis — dipstick, microscopy, albumin-to-creatinine ratioImmunoassays — cytokines, biomarkers, PD markers (ELISA, MSD, Luminex)Flow cytometry — immunophenotyping, cell counts, receptor occupancy
Compliance

Compliance Standards

LIMSera helps you meet and maintain compliance with these regulatory and accreditation requirements.

ICH GCP (E6 R2/R3) — Good Clinical Practice
21 CFR Part 11 — Electronic Records and Signatures
CAP/CLIA accreditation for central lab operations
GCLP — Good Clinical Laboratory Practice
Case Study

“A central laboratory supporting 40+ concurrent clinical trials cut specimen processing turnaround from 72 hours to 24 hours and reduced query rates from investigator sites by 45% using LIMSera's protocol-driven workflows.”

Read the Full Story

See LIMSera in Action for Clinical Research

Get a personalized walkthrough tailored to clinical research laboratory workflows, compliance needs, and integration requirements.

Request a Demo