Connect the scientific evidence
Keep studies, methods, samples, instruments, results and calculations linked in one continuous record.
BIOANALYTICAL LIMS & ELN SAPIO SCIENTIFIC AI PLATFORM
Bioanalysis software that moves science forward.
Sapio Bioanalysis software unifies bioanalytical data management across method development, assay validation, studies, samples, instruments, analysis and reporting. Start with governed Bioanalytical LIMS and ELN workflows—and extend them with native Scientific AI when and where it fits your laboratory.
GLP & GCLP readyComplete traceabilityNo-code configurable
BIOANALYSIS ON THE SAPIO SCIENTIFIC AI PLATFORM
Bioanalysis software built for the way modern laboratories work.
Bioanalytical LIMS and Bioanalytical ELN software should do more than track samples. It should connect the scientific evidence from method design through the final report—while protecting workflow control, data integrity and traceability.
DESIGNED FOR
Pharmaceutical, biotechnology, CRO and CDMO teams operating regulated and non-regulated Bioanalysis workflows.
GLPGCLPGxP21 CFR PART 11
Protect data integrity
Manage versions, permissions, execution, exceptions, approvals and audit history inside governed processes.
Native AI when your lab is ready
Build on governed scientific evidence that enables Elain without making AI a requirement for laboratory operations.
THE SAPIO SCIENTIFIC AI PLATFORM · BIOANALYSIS
One platform, configured for the breadth of Bioanalysis.
Connect laboratory operations and scientific evidence on a governed LIMS and ELN foundation—with scientific AI available when your laboratory is ready.
THE FOUNDATION FOR BIOANALYSIS
Scientific AI Platform
Unified laboratory workflows, scientific evidence and intelligence—on one governed platform.
Govern laboratory operations
Studies, samples, instruments, results, exceptions and approvals.
Explore Sapio LIMS →Connect scientific evidence
Methods, experiments, parameters, calculations and rationale.
Explore Sapio ELN →Extend the governed record
Search, connect evidence and prepare next steps—with scientist review.
Explore Elain →CONFIGURE THE PLATFORM AROUND YOUR SCIENCE
Support different development programs
Small moleculesLarge moleculesCell & gene therapies
Configure the work around the method
LC-MS/MSLigand binding assaysFlow cytometry
Connect results to study context
PK / TKADA / immunogenicityBiomarkers
UNIFIED BIOANALYTICAL WORKFLOW
From method development through final report.
Maintain scientific context, lineage, data integrity and governance through every stage of the Bioanalysis lifecycle—without requiring AI.
Develop
Capture methods, reagents, parameters and scientific rationale.
Validate
Control criteria, versions, approvals and validation execution.
Execute
Connect subjects, samples, plates, reagent lots and instruments.
Analyze
Apply calculations, curve fitting, QC rules, precision and ISR.
Report
Generate traceable, review-ready results connected to the study record.
PURPOSE-BUILT BIOANALYSIS
One environment for quantitative PK and immunogenicity.
Move beyond generic sample tracking. Sapio connects reusable assay methods, controlled execution, purpose-built analysis and approved results to the complete study record.
Turn instrument response into reportable PK results.
Configure controlled assays, standards, QCs and acceptance criteria—then calculate concentrations and evaluate each run with the scientific context intact.
Reusable master assays and controlled method versionsCalibration curves, standards, QCs and run acceptanceLLOQ, ULOQ, BQL and AQL result handlingAccuracy, precision, selectivity, stability and carryover validationStudy-linked results and incurred sample reanalysis
Coordinate every tier of the immune-response workflow.
Keep screening, confirmation, titer and neutralizing antibody analysis connected to the assay, sample, cut point and study.
Screening → confirmatory → titer → NAb workflowsAutomated cut-point calculation and calculation historySignal normalization and positive/negative classificationPercent-inhibition analysis for paired samplesSensitivity, hook effect, specificity and drug-tolerance validation
FROM METHOD TO INSTRUMENT
Execute the assay without losing the scientific thread.
Connect method configuration, plate setup, materials, samples and instrument output in a single governed workflow—reducing manual handoffs and preserving context for review.
MASTER ASSAYS
Standardize methods without making them static.
Create reusable assay templates, manage status and versions, clone approved methods and govern validation and e-signature approval.
Method definition · validation · approval · reusePLATE EXECUTION
Bring the full run together.
Configure plate templates and well assignments; track standards, QCs, controls, reagents, material lots, barcodes and certificate-of-analysis checks.
Plates · wells · controls · materials · samplesINSTRUMENT DATA
Move data directly into the governed record.
Use configurable parsers and scheduled file loading to connect plate-reader, LC-MS and other instrument results to the correct wells, samples and runs.
Automated ingestion · configurable formats · complete linkageSTUDY CONTEXT
Return accepted results to the study.
Create analysis runs from study samples, maintain ISR summaries and review subject-level results across time points and study days.
Subjects · time points · ISR · reportable resultsPURPOSE-BUILT ANALYSIS & REVIEW
See the result. Understand the decision. Defend the evidence.
Give Bioanalysis teams the scientific views and controlled actions they need to move from raw response to an accepted result.
Interactive curve fitting
Review curves across analytes and plates while keeping calculations and assay parameters connected.
- Standards, QCs and sample concentrations
- Per-well exclusion and recalculation
- Run-level LLOQ and ULOQ handling
Controlled run acceptance
Apply configurable QC and acceptance rules, document exceptions and preserve traceable accept-or-reject decisions.
- Validation results in context
- E-signature and audit history
- Controlled reopening and rework
Bioanalysis oversight
Track the state of methods, studies and runs to surface work that needs attention before it becomes a bottleneck.
- Pending, completed and aging runs
- Assay mix and result volume
- Pass rates and operational trends
EXPECTED OPERATIONAL IMPACT
Turn unified Bioanalysis workflows into measurable progress.
DRAFT CLAIMS · FOR VALIDATION
Bring Bioanalysis work and evidence into one governed flow to reduce friction, surface issues sooner and move studies forward with greater confidence.
Keep methods, samples, instrument data, calculations and results connected between stages.
Bring acceptance criteria, quality signals and supporting evidence together for review.
Keep evidence, decisions, approvals and outputs connected and ready for review.
Maintain lineage from method and sample through result, decision and final report.
ELAIN FOR BIOANALYSIS
Meet Elain, Sapio’s Scientific AI co-scientist for Bioanalysis.
Elain is Sapio’s native Scientific AI co-scientist. For AI-forward laboratories, it works across the governed Bioanalysis record to understand context, coordinate work and bring the right evidence forward for human review.
Ask across the study
Search methods, samples, assays, results and prior decisions in natural language.
“Show open QC exceptions”Connect the evidence
Trace signals to governed source records, method versions and acceptance criteria.
3 samples flaggedCoordinate the next step
Prepare reanalysis, review and reporting work inside controlled Bioanalysis workflows.
Workflow readyKeep every action traceable
Maintain evidence, approvals and audit history behind every AI-assisted action.
Source linked ✓S
SCIENTIST-IN-THE-LOOPElain recommends and prepares. Your scientists review, approve and decide.
Discover Elain →BIOANALYTICAL LIMS FAQ
Questions, answered.
Clear answers for Bioanalysis, IT and laboratory leaders.
What is a Bioanalytical LIMS?
A Bioanalytical LIMS manages studies, samples, assays, workflows, analytical results and traceability across Bioanalysis.
What is Bioanalysis software?
Bioanalysis software connects study design, methods, samples, instruments, analytical results, quality controls, approvals and reporting in a traceable scientific record.
What is bioanalytical data management?
Bioanalytical data management organizes and connects methods, study context, sample lineage, instrument data, calculations, results, exceptions and approvals throughout the study lifecycle.
How does Sapio support bioanalytical method validation?
Sapio connects reusable methods, acceptance criteria, validation data, controlled execution, approvals and audit history.
Can Bioanalytical instruments integrate with Sapio?
Yes. Instrument integration can automate data capture and connect results to samples, assays and studies.
What types of Bioanalysis work can Sapio support?
Sapio can be configured for small molecules, large molecules and cell and gene therapies; analytical methods such as LC-MS/MS, ligand binding assays and flow cytometry; and study endpoints including PK/TK, ADA/immunogenicity and biomarkers.
How does Elain support Bioanalysis?
Elain helps scientists search records, summarize readiness, identify exceptions and prepare traceable outputs with human review and control.
SEE SAPIO BIOANALYSIS
See what the Sapio Scientific AI Platform can do for your Bioanalysis laboratory.
Unify your Bioanalysis workflow today—and activate native Scientific AI when and where your laboratory is ready.