The biospecimen operations platform for clinical trials.

The operational layer above EDC, CTMS, LIMS, central lab portals, and BI. AI-native by architecture. Agentic by design. Reconciliation is one capability among many.

Definition

What is a biospecimen operations platform?

A biospecimen operations platform manages the operational lifecycle of clinical trial specimens across sites, sponsors, CROs, laboratories, and logistics providers. It provides sample tracking, projected schedules, cross-vendor reconciliation, kit management, eRequisitions, discrepancy handling, and operational intelligence.

It connects information from systems such as EDC, CTMS, LIMS, laboratory portals, and logistics feeds — rather than replacing those systems.

Why it's a distinct layer

The specimen's journey crosses every system in your stack.

EDC knows the patient. LIMS knows one lab. CTMS knows the study milestones. Central lab portals know what happened at their bench. None of them, alone, know the specimen's cross-system journey.

Sources

  • EDC extracts (Rave, Vault, REDCap)
  • CTMS site enrollment
  • Central lab LIMS feeds
  • PK / ADA / biomarker labs
  • Courier & logistics data
  • Kit vendor inventory
  • Site coordinator scans

Biospecimen operations platform

  • Ingest
  • Normalize
  • Reconcile continuously
  • Detect anomalies
  • Publish reconciled state
  • Serve operational views

Consumption

  • Operational dashboards
  • Feeds into BI (Tableau, Power BI, Spotfire)
  • Warehouse exports
  • eRequisition PDFs to sites
  • Sponsor status reports
  • Submission-ready eTMF
  • SKIA natural-language queries

The platform is the connective tissue. Not an alternative to the connected systems.

What it does

Ten capabilities, not one.

Reconciliation is one capability. Ten more sit alongside it. The platform is the point.

01

Agentic Study Setup

SpeciGen’s first shipped agentic-AI capability. Drop the protocol, Schedule of Activities, and lab manual into the study workspace. The agent takes a goal, plans the extraction, and drafts cohorts, arms, visit schedules, windows, and specimen collections — every value citing its source page. You accept, edit, or reject each line. Amendments run through the same agent as a diff. AI proposes; a human always approves.

02

Per-subject projected collection schedule

Generated from the protocol. Every subject, every visit, every expected specimen. The reference against which everything is reconciled.

03

End-to-end sample tracking

Site collection → courier → lab receipt → processing → storage → consumption. Chain of custody preserved as events on a ledger.

04

Multi-vendor data hub

CSV, Excel, SAS XPT, PDF, imaging, REST API. Any EDC, any LIMS, any lab vendor. Native templates for Medidata Rave, Veeva Vault, and CDISC SDTM.

05

Continuous cross-vendor reconciliation

Every feed reconciled against the projected schedule and against every other feed, on ingest — not on a weekly cron. Anomalies with root-cause clustering.

06

Sample-anchored eRequisitions

The eRequisition attaches to the sample barcode, not the kit. Generate a PDF from what the platform knows, or upload a lab-supplied one. Full version history.

07

Live kit inventory

Real-time stock at every site with days-of-supply and expiry warnings. Coordinators see what to order; sponsors see what's at risk.

08

Site coordinator mobile

Progressive web app on the phone at the collection room. Log a visit, scan a kit barcode with the phone camera, print sample labels, edit raw sample fields. Blinded and unblinded role variants.

09

Discrepancy tracker with e-signatures

Every anomaly gets a rule name, an owner, and a workflow. Resolutions are signed under 21 CFR Part 11 controls and versioned on a hash-chain audit trail.

10

SKIA — natural-language operational query

Ask a question in plain English (“which baby stool samples were collected but not shipped?”) and get a table, count, chart, or narrative back — with CSV or XLSX export.

11

Barcode & label service

Per-study barcode format with atomic sequence generator. Real Code128 graphics on PDF labels. Sites print in-house or SpeciGen prints and ships to each site at cost.

What it does not do

Not a replacement for your existing stack.

A biospecimen operations platform is a distinct layer, not a competitor to the systems you already run. Specifically:

How it's different

Biospecimen operations platform vs. adjacent categories

Adjacent category What it owns How SpeciGen fits alongside it
LIMS One laboratory's internal operations — receipt, aliquoting, assays, results release. SpeciGen ingests the LIMS's extracts and runs cross-lab operations above it.
EDC (Rave, Vault, REDCap) Case report form data — what the coordinator types about a patient visit. SpeciGen ingests EDC extracts to learn what samples the protocol expected.
CTMS Study milestones — site activation, monitoring, financials. SpeciGen exposes specimen operational metrics for the CTMS to consume.
Central lab portal Visibility into what happens inside that central lab. SpeciGen adds visibility across the specimen journey before, during, and after that lab.
BI tool (Tableau, Power BI, Spotfire) Enterprise reporting & visualization across all study data. SpeciGen feeds them the reconciled specimen data they visualize.
Reconciliation tool One capability — matching two files against each other. Reconciliation is one of ten capabilities in a biospecimen operations platform. The platform is the point.

Who it's for

Serves two shapes of study, one platform.

Standalone

Principal investigators & academic cores

A PI, an academic study cohort, or a translational lab that needs a system of record for its own samples. SpeciGen runs standalone — sample tracking, kit inventory, eRequisitions, reconciliation, eTMF. No EDC or LIMS required.

Operational layer

Sponsors & CROs

A biotech, pharma sponsor, or CRO with an existing Medidata / Veeva / LIMS / BI stack. SpeciGen sits above those systems as the biospecimen operations layer, feeds the enterprise reporting environment, and complements the CTMS view.

Common questions

Category FAQ

What is a biospecimen operations platform?
A biospecimen operations platform manages the operational lifecycle of clinical trial specimens across sites, sponsors, CROs, laboratories, and logistics providers. It provides sample tracking, projected schedules, cross-vendor reconciliation, kit management, eRequisitions, discrepancy handling, and operational intelligence — connecting information from EDC, CTMS, LIMS, laboratory portals, and logistics feeds rather than replacing those systems.
How is a biospecimen operations platform different from a LIMS?
A LIMS runs one laboratory's internal operations — receiving samples at that lab, tracking aliquots in its freezers, executing assays, and releasing results. A biospecimen operations platform sits above every LIMS the study touches. It runs the operations that cross organizational boundaries: site collection, courier handoff, receipt at central lab, aliquoting, shipment to specialty labs, results back to sponsor. SpeciGen ingests the central lab's LIMS extracts as one of its inputs; it does not replace that LIMS.
How is it different from an EDC like Medidata Rave or Veeva Vault?
An EDC captures case report form data — what the site coordinator types about a patient visit. A biospecimen operations platform captures what happens to the physical sample after that visit — collection, labeling, chain of custody, lab receipt, processing, results. SpeciGen ingests EDC extracts to know what samples the protocol expected; it does not replace the EDC. Sponsors keep their Medidata Rave / Veeva Vault / REDCap.
Does SpeciGen replace my CTMS?
No. A CTMS runs the study — site activation, monitoring visits, milestone tracking, financials. SpeciGen runs the specimen operations layer. The two coexist; SpeciGen consumes site enrollment status from the CTMS and returns specimen operational metrics that can flow into the CTMS's overall study health view.
Does SpeciGen replace my central lab portal?
No. A central lab portal gives excellent visibility into what happens inside that central lab. A biospecimen operations platform gives visibility across the specimen's operational journey — including everything that happens before the central lab receives the sample and after they ship it onward to specialty labs. Keep the portal; SpeciGen sits above it.
Does SpeciGen replace my BI dashboard (Tableau, Power BI, Spotfire)?
No. SpeciGen feeds them. Reconciled specimen data, kit inventory, and discrepancy signals flow out to the sponsor's BI environment as scheduled exports or live connectors. The BI tool stays the enterprise reporting layer; SpeciGen produces the specimen-domain data it visualizes.
Is reconciliation the whole product?
No. Continuous cross-vendor reconciliation is one capability among many. The platform also handles projected schedules, sample tracking, kit inventory, eRequisitions, site coordinator mobile workflows, discrepancy signatures, an event lifecycle ledger, natural-language operational query (SKIA), and submission-ready eTMF. Reconciliation is a feature; the platform is the point.
Why does biospecimen operations need its own platform?
Because the specimen's operational lifecycle crosses systems and organizations that no single existing platform owns: site → courier → central lab → aliquoting → specialty lab → storage → results. EDC knows the patient. LIMS knows one lab. CTMS knows the study milestones. Central lab portals know what's happened at their bench. None of them, alone, know the specimen's cross-system journey. That gap is what a biospecimen operations platform fills.
What does AI-native and agentic AI mean at SpeciGen?
Two distinct ideas, paired. AI-native means large language models are first-class participants in the platform — not a chatbot bolted onto a legacy configuration engine. Study setup, reconciliation reasoning, anomaly clustering, and natural-language query all sit on the same LLM plumbing shared across dev and production. Agentic AI means SpeciGen ships agents — AI systems that take a goal ("configure this study from these documents"), plan the steps, act using platform tools, and iterate based on human feedback. The Agentic Study Setup is our first shipped agent; more are on the roadmap. Underneath both: every state the platform records — a subject, a visit, an expected specimen, a signed discrepancy — is written by deterministic code against schema-validated data, signed by a human. AI proposes; humans approve; the deterministic core records.
What does “operational layer” mean in practice?
It means SpeciGen consumes signals from every source system — EDC extracts, LIMS files, courier feeds, kit vendor stock, site coordinator scans — and produces one reconciled operational view of every specimen in the study. That view flows back into the sponsor's ecosystem: exports to the data warehouse, feeds to the BI tool, PDF eRequisitions to sites, submission-ready reports to eTMF. SpeciGen is the connective tissue, not an alternative to the connected systems.

See the operational layer in your study.

Bring your protocol, your existing EDC extracts, and your central lab feed. We'll stand up a reconciled operational view in an evaluation pilot.

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