SpeciGen - Smart Biospecimen Management for Clinical Trials

Capabilities

Key Features

Everything you need to manage biospecimens across your clinical trials

Biospecimen Tracker

Hub

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

Data Reconciliation

Hub

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

Compliance & Audit

Hub

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

Integrations & Security

Hub

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

eTMF Generation

Hub

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

Smart Annotations

Hub

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

Results Tracker

Lens

Ingest bioanalytical and assay results, trace samples to outcomes, and manage unblinded data with granular access controls.

Smart Insights

Lens

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 Dashboard

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

Sample Dashboard

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

Real-Time Study Insights

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

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
Infrastructure-level blinding — Hub-only deployments enforce data separation beyond permissions
Per-study user access controls with blinded and unblinded roles

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

Modular Platform

One Platform. Two Powerful Modules.

Start with the operational backbone, add analytical depth when you're ready. Each module is built to work independently or together.

Specigen Hub

Operational Command Center

The central nervous system for your biospecimen operations. Track every sample from collection to storage, reconcile vendor data automatically, and maintain audit-ready compliance.

Multi-vendor sample tracking & reconciliation
EDC & lab data ingestion with anomaly detection
Study configuration, schedules & cohort management
eTMF document management
21 CFR Part 11 compliance & audit trails
Role-based access with blinding controls

Specigen Lens

Analytical Intelligence Layer

See deeper into your trial data. Lens adds bioanalytical results management, unblinded data views, and cross-study analytics on top of Hub's operational foundation.

Bioanalytical & assay results ingestion
Unblinded data access with granular permissions
Result tracking across vendors & timepoints
Sample-to-result traceability
Study intelligence dashboards & analytics
Infrastructure-level blinding protection

Blinding integrity guaranteed. Hub-only deployments enforce data separation at the infrastructure level — not just permissions.

Ready to Transform Your Biospecimen Operations?

Start with Specigen Hub to streamline your operations. Add Specigen Lens when you need analytical depth. Scale at your pace.

Schedule a Demo Contact Sales

Biospecimen Operations. One Platform.

21 CFR Part 11 Compliant

Intelligent Automation

Multi-Vendor, Multi-Format