Clinical Research · Biobanks · CROs

Built by the person
who would have audited it.

VialTracker Cloud was built by a team with hands-on experience at the diagnostic bench, the IVD regulatory approval desk, and Medidata Rave production support. Every compliance claim is verified by AI code review — and the source is available to your validation team.

Diagnostic Lab Bench-level sample processing & QC
IVD Regulatory Body Medical device approval & compliance review
Medidata Rave / LIMS Clinical software production support
VialTracker Cloud Built from the inside out
Request a Demo Explore features
7 Regulatory standards
ALCOA+ Data integrity model
5 Role levels
Code Verified claims
VialTracker Cloud  ·  Dashboard
PI  ·  Read Access
Active Project
ONCO-SG-2025  ·  Phase II Oncology
47
Patients
1,284
Active Vials
99.1%
Collection Rate
Storage  ·  Freezer ULT-04  /  Box 3A
A1
A2
A3
A4
A5
A6
B1
B2
B3
B4
B5
B6
System Audit Log — Recent
Vial Added — ONCO-SR-047-BL-02 → Box 3A / A5
S. Lim · Sample Handler · 09 May 2025 14:33 UTC
Label Printed — ONCO-SR-047-BL-02 (3 copies)
S. Lim · Sample Handler · 09 May 2025 14:31 UTC
Sys Admin PI PM Handler Reviewer
The challenge

When your research reaches the clinic, your records need to match.

Excel served you well at the bench — and it was the right tool for that stage. But clinical biospecimens operate under a different standard: ICH GCP, FDA 21 CFR Part 11, ISO 20387, CAP/CLIA — each demanding full, attributable, tamper-evident records of every sample that moves through your facility.

When a sponsor monitor arrives, or an FDA investigator requests chain-of-custody documentation, the gap between a well-kept spreadsheet and a validated, audit-ready system becomes very expensive, very quickly.

VialTracker Cloud is where that journey leads — a single, web-accessible platform that enforces the workflows your regulatory framework requires and generates the evidence package that proves it.

ICH E6(R2)
GCP Compliance — Full audit trail on every vial and box operation with enforced workflow sequencing.
21 CFR Pt 11
FDA Electronic Records — Secure user credentials and tamper-evident system log with timestamped entries.
ISO 20387
Biobanking — Chain-of-custody from receipt to aliquoting with full hierarchical storage tracking.
HIPAA / GDPR
Patient Privacy — De-identified serial numbers throughout; no PII stored in vial or sample records.
CAP / CLIA
Lab Accreditation — Aliquot tracking with volume and concentration; printable chain-of-custody reports.
Feature suite

Everything your biorepository needs, in one platform.

Ten integrated modules — from freezer configuration to purchasing — covering the complete sample lifecycle without bolt-ons or third-party add-ins.

Freezer Hierarchy Management
Configure unlimited freezers, each with named shelves, racks, and box positions. A real-time visual freezer map shows current occupancy at a glance — from a single unit to a multi-room biorepository across your entire site.
Box & Well Tracking
Create boxes with configurable row/column grids (alpha or numeric). Each well is individually addressed with user-configurable fill order — row-first or column-first.
Vial Lifecycle Management
Add, locate, move, and remove vials with a full audit trail. Tracks initial and current volume, concentration, aliquot number, thaw count, and remarks per individual vial.
Project-Based Access Control
Samples are fully project-scoped. PIs and PMs receive oversight access; sample handlers can only process specimens belonging to their assigned project, protecting multi-sponsor confidentiality.
Patient & Timepoint Registry
Register patients by de-identified serial number and create visit timepoints with dates. Associate multiple sample types per timepoint following your configurable project requirements.
Sample Type Requirements
Define which sample types are required per project stage. The system enforces collection completeness before allowing downstream processing — preventing protocol deviations before they happen.
Barcode & Label Printing
Generate and print vial labels with a configured remote printer. Print records are logged with timestamp and operator for complete regulatory traceability of every label issued.
System Activity Log
Every create, update, and remove action is written to a tamper-evident log capturing operator identity, UTC timestamp, activity type, and full detail string. Exportable for audit submission.
Procurement & Inventory
Track reagent and supply purchases via product catalog, company contacts, and purchase orders. Link consumable lot numbers directly to sample processing batches for traceability.
Built-in Reporting
Pre-built reports for PI/PM summary (patient counts, active vials), sample type inventory by project, consumption trends, and box utilisation. All reports are printable and audit-ready — no third-party BI tools required.
Why trust us

Not a marketing claim.
A code review.

Designed from lived experience, not a spec document
Most biospecimen software is built by developers who read the regulations. VialTracker Cloud was built by a team that has operated inside them — at the bench, at the regulatory desk, and in clinical software support.
1
Diagnostic laboratory — processed samples, ran QC, understood where tracking breaks down at the bench level.
2
IVD regulatory body — reviewed and approved in-vitro diagnostic medical devices; knows exactly what auditors look for and why.
3
Medidata Rave & LIMS support — supported clinical data systems in production; knows where real-world workflows break that demos never show.

"The workflows aren't approximations of what a lab needs. They're what a lab needs — because we've been the lab."

Development Team · LIMS-SIN Tech
Every feature claim verified by AI code review
Every compliance and functional claim on this page was derived from an AI analysis of the actual source code — not written by a marketing team. We don't assert what the system does. We show what it does.
// SystemLog — tamper-evident audit entry public void LogActivity( int userKey, string activity, string detail, int? vialKey) { db.SystemLogs.Add(new SystemLog { User_Key = userKey, OpTime = DateTime.UtcNow, Activity = activity, Detail = detail, Vial_Key = vialKey }); // Row never modified after insert db.SaveChanges(); }
Prospective clients — including QA, IT, and regulatory affairs teams — may request the source code for independent vetting as part of their IQ/OQ validation process.
Request source code for vetting
Audit trail & data integrity

ALCOA+ from the ground up.

Every state-changing operation in VialTracker Cloud writes a signed, non-repudiable record to the SystemLog — capturing operator identity, UTC-aligned timestamp, activity type, and full detail string with foreign-key links to the affected vial and box records.

Records cannot be modified or deleted through the application layer. Combined with SQL Server row-level auditing and column-level permissions, this architecture satisfies ALCOA+ as required by GCP and FDA 21 CFR Part 11.

A
Attributable
L
Legible
C
Contemporaneous
O
Original
A
Accurate
+5
Complete · Consistent · Enduring · Available · Traceable

Role-Based Access Model

System Administrator
Full configuration and user management rights across all projects and freezers.
Principal Investigator (PI)
Read/report access across all project data; cannot modify specimens.
Project Manager (PM)
Oversight of assigned projects; approves patient enrolment and timepoint creation.
Sample Handler (Processor)
Add/remove vials and create timepoints for their assigned project only.
Read-Only Reviewer
Log and report access for sponsor monitors and external auditors.
Regulatory standards

Built to satisfy seven frameworks simultaneously.

VialTracker Cloud maps specific system capabilities to each regulatory requirement — so your site isn't interpreting guidance, it's demonstrating documented compliance.

ICH E6(R2) Good Clinical Practice
GCP-compliant workflow enforcement
Full electronic audit trail (who, what, when) on every vial and box operation; enforced workflow prevents out-of-sequence steps; role-based access mirrors your site delegation log.
21 CFR Part 11 FDA Electronic Records
FDA-ready electronic record system
Secure, unique user credentials; tamper-evident system log; record integrity preserved with UTC-timestamped entries; password policy enforcement at the application layer.
ISO 27001 Information Security
Access controls and least-privilege design
Access controls at project and role level; encrypted connection strings; principle of least privilege enforced via SampleHandler, PI, and PM role separation.
ISO 20387 Biobanking
Chain-of-custody from receipt to disposition
End-to-end custody tracking from sample receipt through aliquoting; full storage location hierarchy (Freezer → Shelf → Rack → Box → Well); documented removal records.
ISBER Biorepository Standards
ISBER Best Practices for biorepositories
Capacity management per box, shelf, and rack; temperature-zone assignment; vial label printing records; thaw-cycle counter per vial with policy enforcement.
HIPAA / GDPR Patient Data Privacy
De-identified by design
Patient serial numbers (de-identified) used throughout the system; no direct PII stored in vial or sample records; project-scoped data access limits exposure across sponsors.
CAP / CLIA Laboratory Accreditation
Laboratory accreditation documentation
Aliquot tracking with volume and concentration; processor attribution on every sample event; printable chain-of-custody and log reports formatted for inspector review during CAP inspections and CLIA surveys.
The translational journey

For labs making the move from bench to clinic.

Three moments where the documentation bar suddenly changes — and where starting right is far easier than retrofitting later.

Sponsored Research
Your first industry collaboration
Your discovery work attracted an industry partner. The sponsored research agreement is signed — and the first thing their clinical operations team asks for is a sample accountability plan. VialTracker Cloud gives you the role-based access controls, timestamped audit trail, and ALCOA+-compliant records you need to answer that question before the first monitoring visit.
Sponsor monitoring ready ALCOA+ audit trail Role controls
Translational Research
Scaling from mouse models to human samples
Your lab is running its first IRB-approved human cohort alongside your in-vivo work. The moment human samples enter your freezer, your documentation standard has to change. VialTracker Cloud enforces per-subject tracking with consent-linked records and a complete chain of custody that holds up to an IRB audit or ethics committee review.
Per-subject tracking IRB audit ready Consent-linked records
Multi-Site Study
Your lab as a receiving site in a clinical trial
You're co-investigator on a clinical trial. Samples are collected at the clinic, transferred to your lab for processing, and stored pending analysis. The sponsor's monitor needs a complete record of every transfer, every aliquot, and every storage event. VialTracker Cloud connects the receipt log to the processing record to the freezer location — so monitoring visits are a report export, not a fire drill.
Sample transfer logs Sponsor-ready reports Multi-site chain of custody
Technical architecture

Enterprise infrastructure,
zero client install.

Platform Stack
Front-end ASP.NET WebForms — any modern browser
Back-end C# · .NET Framework / .NET 6+
Data access Entity Framework 6
Database SQL Server 2016+ · Azure SQL
Hosting IIS · TLS 1.2+ enforced
Authentication Active Directory / Windows Auth
Data Model
Storage hierarchy Freezer → Shelf → Rack → Box → Well → Vial
Project isolation All records scoped to project and authorised users
Scale Bigint PKs on high-cardinality tables
Deletions Soft-delete — rows never physically removed
Integration & Extensibility
RESTful service layer for LIMS, EDC, and LIS integration
Compatible with REDCap and Medidata Rave EDC systems
Remote barcode printer support with configurable label formats per project
Purchasing module links reagent lot numbers to sample processing batches
On-premises SQL Server or Microsoft Azure SQL deployment
Active Directory integration for single sign-on environments
Validation Package

IQ/OQ protocols and a traceability matrix are provided for GCP sites requiring formal system qualification. PQ is site-specific and prepared by your team against your operational environment.

Installation Qualification (IQ) protocol
Operational Qualification (OQ) protocol
Performance Qualification (PQ) test scripts
Requirements traceability matrix
Getting started

From pilot to full production in four stages.

Our implementation team supports every stage — from mapping your existing freezer infrastructure to issuing a regulatory-ready validation package.

1
Site Configuration Workshop
We map your freezer infrastructure, active project list, user roles, and collection protocols into the system during a structured onboarding session.
2
Data Migration
Import your existing specimen inventory from spreadsheets or a legacy LIMS — with our team ensuring data integrity and audit continuity throughout the migration.
3
Validation Package
Receive IQ/OQ protocols, traceability matrix, and system description document. PQ is prepared by your site team against your specific environment and workflows — we provide the system documentation to support it.
4
Training & Ongoing Support
Role-specific training for sample handlers, PMs, PIs, and administrators — plus 24/5 helpdesk, quarterly software updates, and regulatory change monitoring.
Request a demonstration

See VialTracker Cloud
running on your data.

Schedule a live demonstration, request a pilot deployment, or receive the full validation package for your GCP qualification process.

Watch a Demo Request a Live Demo Request Source for Vetting
Built by a regulatory scientist Claims verified by code review IQ / OQ protocols included Source code available on request 24/5 helpdesk