One platform from the bench to the clinic

R&D labs, clinical trial sites, and regenerative medicine labs use Title21 to replace manual data entry with structured, traceable records, so research data is ready for the clinic and the clinic is ready for inspection.

Instrument data, captured with AI

Results and metadata are extracted from CSV, PDF, and scanned reports, checked for errors, and imported with full data lineage.

Chain of identity for trial products

Identity and custody checks follow every investigational cell product from collection to the trial site.

GxP-ready as you grow

Controlled documents, training, and audit trails with 21 CFR Part 11 e-signatures, so moving toward GxP doesn’t mean starting over.
Instrument data, today
AI ingestion across connected labs
Live
  • Cell count report 0415PDFValidated
    1 value flagged for a unit mismatch, reviewer assigned
  • Viability assay 0398ScannedExtracted
    Results and metadata extracted, 24 fields
  • Flow cytometry run 0412CSVImported
    Imported to LIMS, data lineage recorded
  • Potency export 0421XMLUploaded
    Uploaded from the instrument share
312Results imported this week
4Flags awaiting review
0Values retyped by hand
Every value traced to its source file

Illustrative example



One record from the bench to the clinic

Data captured at the bench stays structured and traceable through processing, trial use, and quality review, so nothing is retyped and nothing is lost between teams.

  1. Capture

    Instrument exports and paper records are digitized, and results and metadata are extracted automatically.

    Smart-AId
  2. Validate and import

    Out-of-range values, unit mismatches, and duplicates are flagged for review before data reaches LIMS or ELN.

    Smart-AId
  3. Process and manufacture

    Regenerative medicine and trial products are processed with guided digital records.

    Smart-MES
  4. Trial collection and infusion

    Chain of identity and custody follow investigational products from collection to the trial site.

    Smart-CGT
  5. Quality and readiness

    SOPs, training, and deviations are controlled, and trends stay visible as programs move toward GxP.

    Smart-QMSInsights

Every procedure is captured and reportable, supporting best practices and ongoing improvement for future patients.

Dr. Elena Maryamchik
Director of Cell Therapy Laboratory, Memorial Sloan Kettering Cancer Center

67%

Less work time across 13 cell therapy lab procedures

215 → 70min

Total minutes across those 13 procedures

10 of 13

Procedures cut work time by 50% or more


Source: Memorial Sloan Kettering Cell Therapy Laboratory. Average work time per procedure during downtime compared with Title21 and Epic integration.


LIMS and ELNStructured results and metadata
Instrument exportsCSV, TXT, XML, PDF, and scans
Title21One record for every sample, result, and product
Clinical systemsEHR orders and LIS results
ISBT 128 labelingLabel vendors and printers
Integration health 4 connected0 errors0 in queue

Illustrative example

Built around the systems you already run

Title21 brings data in from instruments, exports, and paper, and sends structured results to your LIMS, ELN, and clinical systems, so nothing is retyped and every value can be traced to its source.

Built for

21 CFR Part 11ALCOA+ISBT 128

Business Case

Get a business case built for your lab

Tell us about your lab and we’ll send you a personalized business case tailored to your research and clinical operations. It shows what manual data entry, transcription errors, and GxP readiness gaps cost your teams today, and how a connected platform pays back as programs move toward the clinic.

Tell us about your company.

See your lab data on one platform.

Bring an instrument export, a paper form, or the handoff that slows your lab down most. We will walk through it with you on Title21.