AI agents for drug development
The AI workforce for biopharma.
Mesenta does the work that isn't science. It works inside Veeva, Medidata, SAS and LabWare, answers in Slack and Teams, and traces every step back to its source record.
Works with the systems you already run
The problem
Drug development wastes months, and millions, on work that isn't science.
Reconciling the same adverse event across two databases. Programming every table twice to prove it's right. Checking that a number in the CSR matches the label, the briefing book and last year's meeting minutes. Skilled people spend their weeks on it, and programs wait.
2×
Every submission dataset and table is programmed twice: once to build it, once to check it.
76%
of clinical trial protocols now have at least one amendment. Phases I–IV, up from 57% in 2015.
260 days
on average from deciding to amend a protocol to its last ethics or regulatory approval.
Amendment figures: Tufts CSDD, Getz et al., Therapeutic Innovation & Regulatory Science, 2024 (950 protocols from 16 sponsors and CROs).
See it work
From “can you QC this?” to a traced answer.
Can you QC ADAE against the spec before we lock?
Double-programmed ADAE from spec v2.3 (1,191 records). 2 discrepancies in TRTEMFL: both AEs start before first dose, so they should not be flagged treatment-emergent. Pinnacle 21: 0 errors, 3 warnings, with draft ADRG notes for each.
Illustrative example on public CDISC pilot data.
Channels
It works where your teams already talk.
Ask Mesenta in Slack, Microsoft Teams or Google Chat, the way you'd ask a colleague. It answers in the thread, with its sources, and everyone following the thread sees the work.
Channels
Connectors
It plugs into your validated systems instead of replacing them.
Nothing moves and nothing is migrated. Mesenta reads from the systems of record you already trust and writes back only through their own controls, after a named person approves.
Research
Clinical
Biometrics
Regulatory
Quality
Collaboration
Company Brain
It remembers what your organization decided, and why.
Mesenta answers from meeting minutes, correspondence and past submissions, and links each sentence to the document it came from. The knowledge stays when people move on.
What did we tell FDA about this endpoint at the pre-NDA meeting?
We proposed the change from baseline in ADAS-Cog (11) at week 24 as the primary endpoint, with CIBIC+ as co-primary.1 FDA agreed and asked for a sensitivity analysis for missing data.2 We committed to include it in Module 2.7.3.3
Routines
Work that runs on schedule, without anyone asking.
Describe a routine in plain English, choose its sources and where results go. Mesenta runs it every night or every Monday and flags only what needs a person.
Conformance sweep on new ADaM deliveries
Runs Pinnacle 21 and CDISC CORE on anything new in the study folder and triages the findings.
✓ 0 new findings
Stability results against open deviations
Compares new LIMS results and analyst notes with the specification and the deviation register.
! 1 result out of spec, no deviation filed
Site activation and enrollment digest
Reconciles CTMS, EDC and the CRO's report and posts what changed to #clin-ops.
✓ Posted to #clin-ops
Governance
It acts as you, never on its own authority.
Mesenta holds no credentials of its own. It works with the permissions of the person who asked. Reads can run on their own; anything that changes a system of record waits for a named person to approve. Every step lands in a tamper-evident audit ledger.
| TIME | PERSON | ACTION | SYSTEM:RECORD | STATUS |
|---|---|---|---|---|
| 10:42:07 | lien.v | request.qc | sas:ADAE@spec-v2.3 | DONE |
| 10:42:31 | mesenta as lien.v | read | sas:ADSL | READ |
| 10:44:12 | mesenta as lien.v | propose.post | sharepoint:QC-LOG | APPROVED |
| 10:51:03 | lien.v | approve | sharepoint:QC-LOG/214 | APPROVED |
| 11:02:48 | mesenta as an.d | propose.update | veeva-qms:DEV-0381 | PENDING APPROVAL |
Solutions
One workforce, from first experiment to filing.
Biometrics
SDTM and ADaM QC, Pinnacle 21 triage, independent TLF checks
Regulatory
Consistency across submissions, HA responses, commitment tracking
Clinical operations
Amendments, SAE reconciliation, site and data status
Quality and manufacturing
Deviations, CAPA, batch records, stability excursions
Research
Literature review, evidence synthesis, ELN and registry work
Business operations
CRO invoices and accruals, board packs, competitor watch
Deployment
Your region, your data, your rules.
- Hosted where you need it: the EU, the US or the region you choose
- Your data is never used to train or fine-tune any model, by us or by any provider
- SAML SSO, SCIM provisioning, role-based access and audit export
- IP allow-listing, data residency, retention and lifecycle controls
Certifications in progress.
Built by
Founded by alumni of McKinsey & Company, the University of Pennsylvania and KU Leuven, and by a Y Combinator alum.
Give your teams back the work that is science.
See Mesenta on your own workflow in a 30-minute demo.