Built for biotech
Training, TMF, and clinical-ops workflows shaped for startups and lean teams — not retrofitted from enterprise software.
Clinical training & TMF for biotech
Training management and a Trial Master File built for startups and lean clinical teams — compliant on day one, without the enterprise rollout.
Live in a day · 21 CFR Part 11 e-signatures built in
How it works
Author an SOP, assign it, sign it, and hand the sponsor a clean record — in one connected loop.
Start from your own draft, pull a controlled SOP from your document system, or turn a file or recording into a course.
Step 1 · Create
Write it yourself, sync a controlled SOP straight from SharePoint or your eTMF, or drop in a file or recording. However it starts, it enters the same governed loop.
See content sources →Biological samples must be processed within 30 minutes of collection. Centrifuge at 1,500 × g for 10 minutes at 4 °C, then aliquot into pre-labeled cryovials.
Aliquots are stored at −80 °C within two hours of collection and logged in the sample manifest before transfer.
Step 2 · Draft & sync
Write and revise SOPs in the editor — autosave, version control, inline review comments, and a Draft → Approved → Published trail, all built in.
See document control →Step 3 · Assign
Pick a study, its sites, and the roles that apply. Deft resolves the exact people in real time, and you can drop in individuals as one-offs. Everyone who matches is enrolled automatically and stays in sync as your team changes.
See the training matrix →Email-verified + PIN signed · 21 CFR Part 11 audit trail
Step 4 · E-sign
Staff complete training and sign off with a compliant e-signature — email-verified, PIN-confirmed, and timestamped. The meaning of every signature is captured.
See e-signatures →Step 5 · Readiness
A live read on completion across every site, so you spot the gap before the sponsor's monitor does. Drill in, nudge the stragglers, and generate the visit pack in a click.
See reporting →Step 6 · Audit
Behind the dashboard sits the proof: every draft, assignment, and signature logged automatically. Export a clean CFR Part 11 trail — or the full QA package — for the sponsor in one click.
See audit & reporting →↻ Revise the SOP and the loop restarts — affected staff are auto-assigned the new version, so training never drifts out of date.
The problem
Startups still have to run compliant trials — and training and the Trial Master File are where site compliance lives. The tools built for that were built for big pharma: heavy to roll out, priced for an enterprise, and far more than a lean team needs.
The old way
With Deft
Why Deft
Training, TMF, and clinical-ops workflows shaped for startups and lean teams — not retrofitted from enterprise software.
Onboard and start in a single day. No implementation project, no integration blockers.
Pricing and structure that match your team — from a single site to a global, multi-site investigation.
The platform
Map every curriculum to roles and sites. Deft assigns the right training to the right people and tracks due dates automatically.
21 CFR Part 11 signatures with email verification and a signature PIN. Every completion is signed, timestamped, and logged.
A flexible TMF that mirrors your study structure, versions every document, and stays inspection-ready.
Draft, review, approve, and publish SOPs with a full version history and approval trail.
See training status across every site at a glance, and export a clean record the moment an inspector asks.
Email-verified + PIN signed · 21 CFR Part 11 audit trail
Training management
Build a training matrix once and Deft keeps it current — assigning curricula by role and site, tracking due dates, and flagging anything overdue. Staff complete training and sign off with a compliant e-signature, so the audit trail builds itself.
Trial Master File
Set up a Trial Master File that mirrors your study, sponsor, and site structure in minutes — no integration, no consultants. Every document is versioned and access-controlled, so the file stays inspection-ready as the trial grows.
Security & compliance
Passwordless login, 21 CFR Part 11 signatures, role-based access, and a complete audit trail come standard. Your data is encrypted and access-controlled, so "is this validated?" has a one-word answer.
21 CFR Part 11 e-signatures, audit trails, and access controls are standard — so your trial stays inspection-ready from day one.
See how Deft runs training and your Trial Master File in one place — live in a day.
Get a demo
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