Assayline · The connected lab suite for bioanalytical CROs and biotech labs
One unbroken line from sample receipt to signed report.
Assayline connects sample custody, guided assays, instrument data, quality, reporting, a sponsor portal and a private AI assistant on one compliance foundation. No number is typed twice, every action is on the record, and your sponsors see their studies live. Built for labs of 10 to 150 people, and priced per site, not per seat.
- In daily use at a working bioanalytical lab since 2018
- Designed around 21 CFR Part 11, GLP and ICH M10
- Unlimited sponsor users, free on every edition
- Your data never trains shared AI models
In daily use
Since 2018
At a working bioanalytical lab
Small labs are held to big-lab standards with spreadsheet tools.
Sponsors expect big-CRO traceability. Most small labs answer with a patchwork of tools.
One result, three places
- Instrument
- Spreadsheet
- Report
Two chances to mistype
Every number is typed twice
Each copy is a delay and a risk.
Sponsor status request
Large CROs show it live
Sponsors are left in the dark
Updates by email and phone.
After an SOP change
- SOP revisedDoc system
- RetrainedSpreadsheet
- Assay runPaper
Nothing stopped the run
Compliance in five places
SOPs and training never meet.
Shared drive
How did we run this before?
No matching worksheet found
Left with the scientist
Know-how walks out
Assay history is lost in old files.
81%
of US scientists spend too much time moving data in and out
Sapio Sciences, 2026
65%
have repeated experiments as past results were hard to find
Sapio Sciences, 2026
45%
use public AI tools through personal accounts for work
Sapio Sciences, 2026
Where Assayline fits
One system of record and one audit trail, from shipment to signed report.
One line from sample to sponsor.
Follow one sample through seven modules, with nothing re-typed.
Shipment notice
Manifest uploaded with the shipment notice.
Format and sample IDs checked.
Before shippingErrors are caught before the box ships.
Inside Assayline
Seven modules, one validated system.
Chain of custody
Every sample accounted for, from the sponsor's manifest to final disposal.
Each sample has a location, a condition, a custody history and limits the system will not let you break.
- One study record
Sponsor, protocol, analytes, matrices, expected sample counts, storage temperatures, stability windows and freeze–thaw limits in one place.
- Receiving that catches problems on arrival
Log shipments, packages, couriers and temperature loggers, and flag temperature excursions the moment a box is opened.
- Accessioning with a resolution trail
Record each sample's condition, reconcile it against the sponsor manifest, and route missing, unidentified or mislabeled samples to a tracked resolution.
- Storage you can see
Building, freezer, rack, box and position, with capacity limits, barcode labels, single-vial and whole-tray scanning, and a complete history for every sample.
- Runs that respect the limits
Request, assemble, check out and return analytical runs. The system warns before a sample breaches its freeze–thaw or stability limit.
- Retention and disposition
Retention periods for each study, sponsor approval before return or destruction, and a disposal certificate.
Something different for every role, on one compliance foundation.
Every module inherits the same controls, so you validate one system and show one audit trail.
Founder / CEO
A sponsor experience to rival big CROs
Lab director
No re-typing, no breached limits
Head of Quality
One system to validate and audit
Study director
Released data, ICH M10 tables
BD / project lead
A live portal to show in every pitch
Your sponsors
Live status and a read-only audit room
7
modules, one compliance foundation
1
system to validate, not five
Unlimited
sponsor users, free on every edition
Since 2018
in daily use at a working lab
Designed around
- 21 CFR Part 11
- 21 CFR Part 58 / OECD GLP
- ICH M10
- ICH E6(R3)
- Annex 11 (GUI-0050)
- FDA CSA
Also built in
- Signatures with meaning
- Audit trail that cannot be switched off
- Single sign-on
- Original files kept
- Sponsors walled off
- Validation pack per release
- Open-format export
- AI never signs
- AI answers cited and logged
- US and Canada hosting
Priced per site. Sponsors always free.
One annual fee per lab site, not per seat, with AI included to a fair-use limit.
Overlay
Keep the LIMS you run
- Connect
- Reports
- Sponsor Portal
- Knowledge AI
Lab Core
Replace paper and spreadsheets
- Samples & Studies
- Bench
- Quality: documents and training
- Reports
- Sponsor Portal
Lab Complete
The full connected suite
- Everything in Lab Core
- Connect and Knowledge AI
- Full Quality: deviations, CAPA, audits
- Insights dashboards
Dedicated
Multi-site or sensitive work
- Any edition
- A dedicated environment
- Custom validation support
Services
- Onboarding and configuration
- Data migration with reconciliation
- Validation package
- Custom instrument connectors
- Archive ingestion into Knowledge AI
Start with the problem that costs you most.
Start where the pain is sharpest, prove it in a pilot, then connect the rest.
- 1
Workflow demo
A study type, end to end
- 2
Paid pilot
60–90 days, your own data
- 3
Validate and go live
Our pack, your data migrated
- 4
Expand
Same records, more modules
Three fast starts
- A branded Sponsor Portal within weeks
- Your busiest instrument on Connect
- A free ICH M10 validation-plan gap check
Questions lab leaders ask us.
No. The Overlay edition adds Connect, Reports, Sponsor Portal and Knowledge AI on top of the LIMS you already run, and Connect delivers reviewed results straight into it. Labs moving off paper and spreadsheets use Assayline as their system of record instead.
Get started with Assayline
See Assayline run one of your studies.
Bring one study type, one instrument export and one sponsor report template. We will walk your team through that sample's journey in Assayline, from the sponsor's shipment notice to the signed report in their portal.
Prefer to pick a time yourself? Schedule a meeting