Protect your IP. Prove data integrity. Share with every CRO.
From preclinical through clinical, your most valuable data crosses organizational boundaries every day — to CROs, CDMOs, labs, sites, and regulators. MnemoShare moves it securely, eliminates the credentials you’d otherwise manage, automates the workflow around it, and consolidates the point tools you’re stitching together.
Application-layer encryption with keys you hold (so even we can’t read your compound data), a hash-chained audit your inspectors can verify, and 21 CFR Part 11 / GxP-aligned e-signatures — deployed self-hosted for full data residency, or as managed SaaS.
Modern biotech runs on outsourced, multi-party data
Almost every critical dataset crosses an org boundary — which is exactly where it gets exposed. Legacy tools make that slower, riskier, and harder to defend, in three ways.
The External Data Bottleneck
Assay data, batch records, and study documents move to CROs, CDMOs, and sites as email attachments and ad-hoc SFTP — slow, unauditable, and impossible to prove chain of custody at submission.
IP Walking Out the Door
Your sequences, formulations, and compound data are the company. One leaked dataset — accidental or malicious — can erase the value. Consumer tools can’t even see it leave.
The Part 11 & Data-Integrity Burden
Inspectors expect ALCOA+ data integrity and 21 CFR Part 11 audit trails on every record. Most file tools can’t prove a record wasn’t altered after the fact.
From the lab bench to the IND — one secure platform
The same platform handles every sensitive exchange across your pipeline — automated, audited, and consolidated instead of cobbled together from CRO portals and email.
CRO / CDMO Data Exchange
Move assay, tox/PK, batch, and QC data with contract partners through tracked, expiring links — replacing email attachments and brittle SFTP, with chain of custody on every file.
CROs, CDMOs, CMOs
Clinical Trial Document Exchange
Exchange essential study documents with sites and CROs (eTMF/eISF-adjacent), with workflow prompts for missing docs and inspection-ready access for FDA and EMA.
eTMF/eISF, sites, monitors
IP & Research-Data Protection
Keep trade-secret sequences, formulations, and assay IP from leaking during external collaboration — application-layer encryption with keys you hold, granular access controls, and configurable DLP that inspects data on its way out.
Trade secrets, compound data
Regulatory Submission Handoff
Stage and securely transmit large eCTD / IND / NDA packages to regulatory-affairs partners and toward the FDA gateway — with verifiable document integrity at every step.
IND/NDA/BLA, eCTD
Part 11 E-Signature & Approvals
Capture identity-verified, audit-trailed electronic signatures on quality documents, CTAs, batch records, and consent — uniquely linked to the signer and independently verifiable.
Quality docs, CTAs, consent
Investor Due-Diligence Data Rooms
Stand up a secure, fully-audited data room for fundraising, partnering, and licensing — and finally have a real answer to the VC security questionnaire.
Fundraising, BD, licensing
One platform, built for biotech R&D
MnemoShare removes the credential burden, automates the workflow around your outsourced data, and consolidates the tools you’d otherwise buy separately.
No Partner Credentials to Manage
Share with every CRO, CDMO, and site through short-lived, identity-bound access — no partner accounts to provision, rotate, or revoke. Add hardware-bound identity (mTLS, YubiKey, or TPM) for phishing-resistant access that targets NIST AAL3.
- No standing user credentials to steal
- Zero partner accounts to manage
- Optional hardware-bound identity (targets AAL3)
Workflow Engine + Integrated AI
Automate intake, classification, routing, and approvals across your outsourced workflows. Integrated AI detects sensitive data (PHI/PII), classifies documents, and flags anomalies as files move.
- Automate CRO/CDMO intake and routing
- AI-driven content scanning & DLP
- Anomaly detection on every transfer
Consolidate Your Stack
Secure file transfer, email + DLP, web forms, e-signature, and one-time secrets in one platform — a lighter alternative to heavyweight validated suites, without stitching point tools together.
- Replace 4–6 point tools with one
- One audit trail across every channel
- Lighter and faster than validated-suite overhead
Part 11 & GxP Evidence, by Design
Hash-chained, ALCOA+-aligned audit your inspectors can cryptographically verify, application-layer encryption with keys you hold, and Part 11-aligned e-signatures. We produce the evidence; your validated process owns the certification.
- Independently verifiable, hash-chained audit
- App-layer encryption — even we can't read your data
- Supports 21 CFR Part 11 & GxP (ALCOA+)
Designed to support 21 CFR Part 11 & GxP
MnemoShare maps to the Part 11 technical controls and produces the evidence — your validated process owns the certification.
§11.10(e) — Audit Trail
Hash-chained, time-stamped, independently verifiable audit of every action — ALCOA+ aligned and exportable to your SIEM or WORM storage.
§11.10(d) — Access Controls
Identity-bound, ephemeral access with role-based permissions and optional hardware-bound mTLS — only authorized people, every time.
§11.50 / §11.70 — Electronic Signatures
PAdES electronic signatures uniquely linked to a verified signer and Adobe-verifiable, backed by the tamper-evident audit trail.
§11.300 — Identity Controls
Unique user identification with no shared partner credentials to compromise — every signature and access tied to a real person.
MnemoShare supports your 21 CFR Part 11 and GxP (ALCOA+) data-integrity workflows and produces the evidence — it does not replace your validation process or hold certifications on your behalf.
Self-hosted or managed — your call
Seed and preclinical teams move fast on managed SaaS; clinical-stage companies run the same platform fully self-hosted for data residency and IP sovereignty.
Governed (Self-Hosted)
Run entirely within your own infrastructure for full data residency and IP sovereignty — keep genomic and compound data in your environment, which also helps with the DOJ Bulk Sensitive Data Rule. Ideal for clinical-stage.
- Full data residency & key control
- Runs in your data center or VPC
- No vendor access to your IP
Managed SaaS
Dedicated, isolated instances managed by MnemoShare — the fastest path to a secure, audit-ready exchange for seed and preclinical teams without an infrastructure team.
- Per-organization isolation, no shared tenancy
- Working deployment in minutes, not a 6-month project
- Customer-held encryption keys
Your IP is only as secure as your weakest partner portal
Accellion, MOVEit, and GoAnywhere — the file-transfer tools behind some of the largest breaches of pharma and clinical data — all relied on stolen credentials and readable data. MnemoShare has neither: no standing user credentials, application-layer encryption with keys you hold, and zero known CVEs. Native importers migrate you off legacy MFT in days, not quarters.
See MnemoShare for your pipeline
A 15-minute demo and a 21 CFR Part 11 / IP-protection gap review, mapped to how your team actually works with CROs and partners.
Request a Demo