Sample Tracking.
Biospecimen Operations.
Site to Sponsor. One Platform.

SpeciGen is an AI-native biospecimen operations platform for clinical trials — from barcode scanning at the collection bench, through cross-vendor reconciliation, to submission-ready eTMF closeout. Works standalone for PIs and academic cores, or as the operational layer above your EDC, CTMS, LIMS, and central lab portal. Deterministic core, AI-assisted where it earns its keep. 21 CFR Part 11 attested.

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AI-Powered Multi-Vendor HIPAA 21 CFR Part 11 GxP ICH E6

Free pilot — live now

Reconcile a study in an afternoon.

SpeciCheck is the SpeciGen recon engine, unbundled and free. Drop your EDC extract, central-lab file, and PK-lab file. SpeciCheck maps the columns, joins on subject / visit / specimen / date, and hands back a reconciled master table plus every anomaly worth a look.

  • 16 built-in reconciliation rules
  • Deterministic engine, no LLMs on your data
  • PDF + XLSX export

SpeciCheck

No call. No install. No credit card — sign in with your work email and start reconciling.

Test Drive SpeciCheck →

Desktop only · work email required

Ingests from every vendor feed

Medidata Rave Veeva Vault REDCap CDISC SDTM SAS XPT CSV / Excel PDF Pathology imaging SFTP S3 Google Cloud Storage Azure Blob REST API Medidata Rave Veeva Vault REDCap CDISC SDTM SAS XPT CSV / Excel PDF Pathology imaging SFTP S3 Google Cloud Storage Azure Blob REST API
0
Modules
Site, Hub, and Lens — take independently or together.
21 CFR
Part 11 attested
Independent third-party assessment, 2026-Q2.
1-click
eTMF report
Submission-ready at any milestone.
Every
Recon run
AI root-cause clustering on top of deterministic rules.

Works with your existing ecosystem

SpeciGen sits above your stack. It does not replace it.

A biospecimen operations platform is a distinct layer. Keep your EDC, CTMS, LIMS, central lab portal, and BI stack. SpeciGen consumes their signals, reconciles them across vendors, and hands the reconciled state back.

Above your EDC

Medidata Rave · Veeva Vault · REDCap

Keep your Rave. SpeciGen reads its extracts, reconciles them cross-vendor against the protocol, and hands the reconciled specimen state back.

Alongside your CTMS

Your CTMS runs the study

The CTMS owns milestones, site activation, financials. SpeciGen owns specimen operations — and exposes metrics that flow into your CTMS's study health view.

Above your LIMS & lab portals

Every LIMS the study touches

A LIMS runs one lab. SpeciGen runs the operations that cross labs — site → courier → central lab → specialty labs → results back. Central lab portals stay; SpeciGen adds the cross-vendor view.

Feeds your BI

Tableau · Power BI · Spotfire

SpeciGen does not compete with your BI tool. Reconciled specimen data, kit inventory, and discrepancy signals flow out as scheduled exports or live connectors.

Learn more about the biospecimen operations platform category.

Capabilities

Key Features

Everything you need to manage biospecimens across your clinical trials

Biospecimen Tracker

Hub

Track every sample from collection through processing, storage, shipment, and destruction — per subject, per visit, per aliquot.

Continuous Reconciliation

Hub

Auto-match lab samples to EDC records. Deterministic rules first; an AI advisory pass clusters anomalies into root causes and drafts vendor queries.

Compliance & Audit

Hub

21 CFR Part 11 attested. Electronic signatures, consent tracking, hash-chain audit log with before/after diffs, AES-encrypted at rest, study closeout.

Integrations

Hub

Native EDC (Medidata Rave, Veeva, REDCap), analytics (Tableau, Spotfire), Slack, SSO/SAML, and REST APIs for anything else.

eTMF Generation

Hub

Milestone-ready eTMF documents and Clinical Study Reports, generated from the live study state — not hand-assembled.

Site Coordinator

Site

Coordinators log visits, scan kit barcodes, and edit sample data — on a phone or laptop at the collection room, or at a desk. Blinded and unblinded variants; every action audit-logged.

Results Tracker

Lens

Ingest bioanalytical and assay results, trace every sample to its outcome, manage unblinded data with granular access controls and infrastructure-level blinding.

SKIA

Lens

SpeciGen Knows It All — plain-English queries over your study data (“show me subjects with missed C1D1 PK draws”). Answers include the underlying rows and cite their source.

New in 2026

Built for how your team actually works

Latest releases: mobile-first tools for sites, sample-anchored eRequisitions, live kit-inventory forecasting, and AI-augmented reconciliation.

Site Coordinator

Site

A dedicated surface for on-site coordinators — on desktop and as a mobile PWA. Log a visit, scan a kit barcode with any device camera, edit any raw sample field — every change audit-logged. Blinded and unblinded variants keep each site to their own subjects.

Sample-Anchored eReqs

Hub

eRequisitions attach to the sample barcode, not to a kit — because a kit ships multiple tubes and each tube has its own chain of custody. Generate a PDF from what SpeciGen knows, or attach a lab-supplied one. Full version history. Sites print labels in-house from the PDF export, or SpeciGen prints and ships them at cost.

Live Kit Inventory

Hub

Per-site kit inventory with at-risk tiles, days-of-supply projections, expiry warnings, and consumption vs shipment reconciliation. Sponsors see what's running low; sites see what's due.

AI-Augmented Recon

Lens

Deterministic recon runs first; an advisory AI pass clusters anomalies into root causes, drafts vendor queries, and downgrades severity where safe. AI is always advisory — humans stay in the loop.

Schedule a 30-min demo →

How It Works

How the operational layer runs a study

Ingest every vendor signal. Reconcile against the protocol. Publish the reconciled state.

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.

Legacy sample-tracking tools 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

SpeciGen Knows It All 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

Study Home Dashboard

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

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

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

Compliance & Trust

Built for Regulated Clinical Workflows

SpeciGen is engineered as a multi-tenant SaaS for clinical biospecimen operations, with controls aligned to the regulations a clinical-trial sponsor, contract research organization, or central lab is held to.

21 CFR Part 11

Electronic records and electronic signatures compliant with FDA 21 CFR Part 11. SHA-256-bound signatures, hash-chain audit trail, unique user identification, and role-based access. Independently attested by a third-party assessor.

HIPAA

Business Associate posture aligned to the HIPAA Privacy, Security, and Breach Notification Rules. AES-256 at-rest encryption (KMS-managed), TLS 1.3 in transit, role-based access, breach notification within statutory windows. BAA executed with every customer.

GxP

Good documentation, traceability, and validation across the software development lifecycle. Validation procedure (IQ/OQ/PQ) documented in SOP-018; change control under SOP-010; data integrity per SOP-016 (ALCOA+).

ICH E6(R3) · ALCOA+

Aligned to ICH E6(R3) data integrity principles — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available. Every action carries user identity, timestamp, and is immutable in the hash-chain audit log.

GDPR

SpeciGen acts as data processor; the sponsor is data controller. DPA signed alongside the SOW. Data subject rights, lawful basis at SOW level, breach notification within statutory windows. EU regional deployment available for in-country residency.

Full QMS & SOPs

Quality Management System with 3 top-level documents (QMS Manual, Quality Policy, Organisation & Responsibilities), 20 numbered SOPs, and 37 supporting policies covering SDLC, change control, validation, incident response, backup/restore, data integrity, and electronic records. Available under NDA on request.

Penetration tested annually. Hash-chain audit trail. AWS CloudTrail multi-region with log-file validation. Daily encrypted RDS snapshots with point-in-time recovery.

Modular Platform

One Platform. Three Modules.

Site collects. Hub reconciles. Lens analyzes. Each module works independently or together — take what you need, add the rest when you're ready.

SpeciGen Site

In-Clinic Companion

The coordinator's workspace — on a phone or laptop at the collection room, or at a desk between visits. Log a visit, scan a kit barcode, attach a requisition, edit any raw sample field. Each site sees only their own subjects — every action audit-logged.

  • Runs on desktop and as a mobile PWA (add to home screen)
  • Kit barcode scanning via any device camera (laptop, tablet, iOS + Android)
  • Log a site visit — subject, visit, specimen, kits, airway bill
  • eRequisitions per sample — generate, upload, download
  • Blinded and unblinded variants — scoped per (user, study, vendor)
  • Per-subject projected schedule always at hand

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 Test Drive SpeciCheck

SpeciCheck is our free biospecimen reconciliation pilot — drop your EDC extract and lab files, see reconciled results in minutes.