The Biospecimen Operations Platform

Biospecimen Operations.
One Platform.

From specimen tracking to data reconciliation to regulatory compliance — SpeciGen covers the full lifecycle of biospecimen operations for clinical trials.

Schedule a Demo Explore Features

21 CFR Part 11 Compliant

Full audit trails, e-signatures, and regulatory compliance built in

Intelligent Automation

Natural language queries, anomaly detection, and smart data matching

Multi-Vendor, Multi-Format

CSV, Excel, PDF, SAS — ingest data from any vendor in any format

Capabilities

Key Features

Everything you need to manage biospecimens across your clinical trials

Biospecimen Tracker

Biospecimen Tracker

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

Reconciliation

Data Reconciliation

Auto-match lab samples to EDC records with manual override and anomaly detection.

Compliance

Compliance & Audit

21 CFR Part 11 compliant with e-signatures, consent tracking, audit logs, and study closeout.

Integrations & Security

EDC integration (Medidata Rave, Veeva, REDCap), analytics (Tableau, Spotfire), SSO, and encryption.

eTMF

eTMF Generation

Generate Clinical Study Reports and FDA-ready eTMF documents automatically.

Smart Annotations

Smart Annotations

Extract, annotate, and map data from PDFs — pathology and lab reports.

Translational Operations

Translational Operations

End-to-end support with specialist consultation — from sample tracking & reconciliation to the full spectrum of biospecimen operations.

Smart Insights

Natural language queries, real-time dashboards, and intelligent analytics for study metrics.

How It Works

From Raw Data to Regulatory-Ready

Three steps to transform your biospecimen operations

Upload & Ingest

Import data from EDC systems, central labs, and vendors in any format. Our system automatically maps columns and validates your data.

Reconcile & Analyze

Automatically match EDC to lab results, detect anomalies, and surface data quality issues with AI-powered reconciliation.

Report & Close

Generate compliance reports, eTMF documents, and clinical study reports. Complete study closeout with full audit trails.

The SpeciGen Difference

Instant Results. Not Days. Not Weeks.

Traditional biospecimen platforms make you wait — days for reconciliation, weeks to incorporate protocol amendments, months for study closeout reports. SpeciGen does it in seconds.

Reconciliation

Days to weeks Minutes

Upload your data and reconciliation runs immediately. Anomalies surfaced the moment data lands.

Protocol Amendments

Weeks of rework Same day

Visit schedules change? New sample types added? Update your configuration and the platform adapts instantly.

Data Queries

Custom reports queue Seconds

Ask SpeciGen any question in plain English. No SQL, no ticket to IT, no waiting for the next reporting cycle.

New Vendor Data

Custom integration Upload & map

Any vendor, any format. Upload a file, map the columns, and you're live. No integration project required.

eTMF & Reports

Manual assembly One click

Clinical Study Reports and eTMF documents generated automatically from your reconciled data. Always current.

Built for Change

Rigid workflows Configurable

Studies evolve. SpeciGen adapts — new sites, changed visits, additional vendors — without re-implementation.

Platform

See It In Action

A modern, intuitive interface designed for clinical research teams

Study Home Page

Study Home Dashboard

Complete overview of your study — subjects, samples, compliance rates, and issues requiring attention.

Sample Dashboard

Sample Dashboard

Track specimens and reconciliation status across all subjects with powerful filtering options.

Study Insights

Real-Time Study Insights

Data quality, sample compliance, EDC-lab matching, and sample distribution — all updated in real-time.

Ask Specigen AI

Ask SpeciGen — AI Queries

Query your study data using natural language and get instant, exportable results powered by AI.

Industries

Built for Clinical Research

Trusted by organizations across the clinical trial ecosystem

Pharma & Biotech

Streamline biospecimen operations across Phase I-IV clinical trials. SpeciGen handles the complexity of multi-site, multi-vendor studies so your team can focus on what matters — getting therapies to patients.

  • Manage complex sample collection schedules across 100+ sites
  • Reconcile EDC data against multiple central lab vendors automatically
  • Generate FDA-ready eTMF documents and clinical study reports
  • Integrate with Medidata Rave, Veeva Vault, and REDCap

SpeciGen for Pharma & Biotech

Tracking & Reconciliation

Multi-site sample lifecycle & EDC-lab matching

Compliance & Reporting

21 CFR Part 11, eTMF generation & study closeout

Contract Research Organizations

Manage biospecimen operations across multiple sponsors and studies efficiently. SpeciGen's multi-tenant architecture means one platform for all your clients, with role-based access and customizable workflows.

  • Multi-tenant study management with sponsor-level isolation
  • Configurable workflows per study protocol
  • Cross-study analytics and reporting dashboards
  • Scalable from a single study to hundreds of concurrent trials

SpeciGen for CROs

Multi-Study Management

Tracking & reconciliation across sponsors

Analytics & Reporting

Cross-study dashboards & compliance reporting

Central Laboratories

Integrate seamlessly with clinical sites and sponsors. SpeciGen ingests your lab results in any format and provides visibility into sample status, result delivery, and data quality.

  • Ingest lab result data via CSV, Excel, PDF, or SAS datasets
  • Automated PDF template mapping for recurring reports
  • Match sample receipt to shipment records automatically
  • Real-time data quality visibility for sponsors and sites

SpeciGen for Central Labs

Data Ingestion

CSV, Excel, PDF, SAS — any format, auto-mapped

Sample Reconciliation

Receipt-to-shipment matching & result delivery

Academic & Medical Device

Right-sized for investigator-initiated trials and device studies. SpeciGen scales down to single-site studies without sacrificing regulatory compliance or data integrity.

  • Affordable deployment for academic research centers
  • REDCap integration for investigator-initiated trials
  • Translational medicine sample workflows
  • IRB-ready consent tracking and documentation

SpeciGen for Academic & Device

Specimen Tracking

Collection, processing & lifecycle management

Consent & IRB Docs

Consent tracking & regulatory documentation

Ecosystem

Integrates With Your Stack

EDC Systems

Medidata Rave, Veeva Vault, REDCap

File Formats

CSV, XLS/XLSX, PDF, SAS7BDAT, XPT

Analytics

Tableau, Spotfire, Built-in Dashboards

Security

SSO, RBAC, Encryption, Audit Trails

Ready to Transform Your Biospecimen Operations?

Join leading pharmaceutical companies and CROs who trust SpeciGen for their biospecimen management needs.

Schedule a Demo Contact Sales