Smart Biospecimen Management

Transforming Biospecimen Operations — Automating Sample Collection Compliance, Unifying Vendor Data, and Streamlining Sample Workflows

Key Features

Specimen Tracker

Track biospecimen lifecycle across collection, processing, storage, shipment, and destruction.

Smart & Flexible Anomaly Detection

Automatically detect missing, delayed, or inconsistent sample data consistent with protocol defined schedules.

Data Reconciliation Engine

Reconcile Vendor and EDC data with intelligent conflict resolution and audit trails.

eTMF Integration

Instant eTMF ready reports for Audits and Regulatory readiness.

Study Schedule Integration

Validate uploads against expected visits, arms, and timepoints defined in per-study schedules.

Ask Specigen Chatbot

Query any study, sample, or upload using natural language — with filters, charts, and exports.

Per-Study & Per-Tenant Dashboards

Visualize study health, anomaly trends, reconciliation summaries, and sample status.

Compliance & Security Ready

Built with HIPAA-grade infrastructure, tenant-level isolation, audit logging, and role-based access.

Inline Editing & Resolution

Resolve anomalies or reconcile rows directly from the Specimen Tracker interface.

Complete Analytics for Biospecimen Management

Access to powerful analytics to optimize sample collection, processing and protocol compliance across your study.

Key Feature

Specimen Tracker

Track biospecimen lifecycle across collection, processing, storage, shipment, and destruction.

Smart & Flexible Anomaly Detection

Automatically detect missing, delayed, or inconsistent sample data consistent with protocol defined schedules.

Data Reconciliation Engine

Reconcile Vendor and EDC data with intelligent conflict resolution and audit trails.

eTMF Integration

Instant eTMF ready reports for Audits and Regulatory readiness.

Study Schedule Integration

Validate uploads against expected visits, arms, and timepoints defined in per-study schedules.

Ask Specigen Chatbot

Query any study, sample, or upload using natural language — with filters, charts, and exports.

Per-Study & Per-Tenant Dashboards

Visualize study health, anomaly trends, reconciliation summaries, and sample status.

Compliance & Security Ready

Built with HIPAA-grade infrastructure, tenant-level isolation, audit logging, and role-based access.

Inline Editing & Resolution

Resolve anomalies or reconcile rows directly from the Specimen Tracker interface.

Complete Analytics for Biospecimen Management

Access to powerful analytics to optimize sample collection, processing and protocol compliance across your study.

How It Works

01

Ingest Vendor Data

Standardization of spreadsheets & API inputs

02

Anomaly Detection

Detect anomalies & create discrepancy trackers

03

Sample Reconciliation

Reconcile vendor/sample inventory data with EDC data

04

Real-Time Insights

Query the chatbot for instant sample tracking

05

Automate Compliance Reports

CAP, CLIA, FDA-ready reports

06

Managed Services

Full-service biomarker operations support, compliance tracking, and data reporting

Who We Serve

Biotech & Pharma Companies

Clinical Research Organizations (CROs)

Academic & Research labs

Clinical Trials Central Labs & Specialty Labs

Analytical labs

Data Management Vendors

Specigen in Action

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