Clinical training & TMF for biotech

Lean clinical operations 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

One training loop, draft to inspection

Author an SOP, assign it, sign it, and hand the sponsor a clean record — in one connected loop.

Deft — New training
New training · choose a source

Start from your own draft, pull a controlled SOP from your document system, or turn a file or recording into a course.

Edit your ownAuthor an SOP in the platform editor
Sync from SharePoint / eTMFPull a controlled document, version-linked✓ Pulled SOP-014 · v1.4 — kept in sync
Upload file, video or linkPDF, MP4, or a recording URL
Continue

Step 1 · Create

Start a training from anywhere

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 →
Deft — SOP-014 · Sample handling
Draftediting Pending approvalawaiting reviewer Approvedready to publish Publishedv—
Saving…✓ Saved just now Submit for approval
Sample Handling & Storage
SOP-014 · Linked curriculum: GCP Refresher

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.

Discussion 2
“…stored at −80 °C within two hours…”
ROR. Okafor
Quality Lead · 2h
Should this match the kit manual (−70 °C)?
Accept & resolve
✓ Resolved · now −70 °C

Step 2 · Draft & sync

Author SOPs right in the platform

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 →
Deft — Assign training
Assign · GCP Refresher
Study
Select a study…
PROTEUS-2 Phase III · 6 sites
HELIOS-1 Phase II · 3 sites
ORION-4 Phase III · 9 sites
Sites
SITE-001 · DenverPI: Okafor · 14 staff
SITE-002 · AustinPI: Reyes · 9 staff
SITE-003 · BostonPI: Nyong · 11 staff
SITE-004 · SeattlePI: Park · 6 staff
Roles
Investigator INV Clinical Research Coord. CRC Study Nurse RN Pharmacy PHM
Due date
14 days 30 days 60 days · complete by Jul 25, 2026
Will be enrolled 0people
Pick a study, sites & roles to resolve people.
AODr. Amara OkaforInvestigator · Denver
LRLena ReyesCRC · Austin
JPJames ParkCRC · Boston
PSPriya ShahStudy Nurse · Denver
TBTom BeckerStudy Nurse · Austin
+28 more matched by role
MGMaria GomezIndependent Auditoradded
+ Add individual…
Save assignments

Step 3 · Assign

Assign by study, site and role — not by hand

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 →
Deft — Sign to complete
Confirm your e-signature
GCP Refresher · SOP-014 v4.0
I completed and understood this training
····
Sign & complete
AM Amara Mensahamara.mensah@deft.com · Jun 24, 2026 14:32 UTC · 10.2.4.8

Email-verified + PIN signed · 21 CFR Part 11 audit trail

Step 4 · E-sign

21 CFR Part 11 signatures, built in

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 →
Deft — Training readiness
Site readiness
PROTEUS-2 · GCP Refresher v1.4
Monitoring visit · Jul 8
0%
0staff trained & signed
0sites monitoring-ready
0site at risk before the visit
SITE-001 · Denver0%Ready
SITE-002 · Austin0%Ready
SITE-003 · Boston0%At risk
SITE-003 · Boston — 4 staff overdue Click a site to drill in
PersonOverdue trainingLate
SLSarah LindqvistStudy NurseGCP Refresher v1.412dRemind
MWMarcus WebbClinical Research Coord.GCP Refresher v1.49dRemind
PNDr. Priya NairSub-InvestigatorGCP Refresher v1.45dRemind
TFTomás FerreiraStudy NurseGCP Refresher v1.43dRemind
Send reminder to all 4 Generate site visit report

Step 5 · Readiness

Know you're inspection-ready, site by site

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 →
Deft — Audit log
Audit trail
CFR Part 11 Export CSV
TimestampUserActionIP
Jun 24 · 14:32 A. MensahClinical Research Coord. training_completed 10.2.4.8
Jun 24 · 14:32 A. MensahClinical Research Coord. signature_applied 10.2.4.8
Jun 22 · 09:15 R. OkaforQuality Lead document_published 10.2.4.2
Jun 20 · 16:40 R. KapoorSite Investigator training_assigned 10.2.4.9
Sponsor QA package · 148 records · all signatures verified Exported ✓

Step 6 · Audit

Every action, on the record

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

Big-pharma tooling doesn't fit a startup trial

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

  • Training tracked across spreadsheets and email; audit prep is a fire drill.
  • A Trial Master File means a six-figure platform and a months-long integration.
  • Tools built for big pharma, priced for big pharma.

With Deft

  • Assign, track, and e-sign training by role and site in one place.
  • A TMF that's ready on day one and scales with the trial.
  • Flexible and compliant, priced for the team you actually have.

Why Deft

Powerful where it counts, light everywhere else

Built for biotech

Training, TMF, and clinical-ops workflows shaped for startups and lean teams — not retrofitted from enterprise software.

Lean

Onboard and start in a single day. No implementation project, no integration blockers.

Scalable

Pricing and structure that match your team — from a single site to a global, multi-site investigation.

The platform

Everything a lean clinical team runs on

Training matrix

Map every curriculum to roles and sites. Deft assigns the right training to the right people and tracks due dates automatically.

E-signatures

21 CFR Part 11 signatures with email verification and a signature PIN. Every completion is signed, timestamped, and logged.

Trial Master File

A flexible TMF that mirrors your study structure, versions every document, and stays inspection-ready.

SOP & document control

Draft, review, approve, and publish SOPs with a full version history and approval trail.

Audit & reporting

See training status across every site at a glance, and export a clean record the moment an inspector asks.

Deft — Training
Training matrix
Site 01 — Denver 86% trained
Team memberCurriculumDueStatus
AMA. MensahClinical Research Coord. GCP Refresher Apr 2 Completed
RKR. KapoorSite Investigator Site Activation Jun 30 Pending
JLJ. LiuStudy Nurse Protocol NS-204 May 12 Overdue

Training management

Every site trained, every record signed

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.

  • Role- and site-based assignment, synced automatically as your team changes
  • 21 CFR Part 11 e-signatures — email verification plus a signature PIN
  • Live status across every site, exportable for inspection
See training management →
Deft — Assignments
Assignments
By role & site Auto-synced
Team memberCurriculumDueStatus
RKR. KapoorSite Investigator Site Activation Jun 30 Pending
AMA. MensahClinical Research Coord. GCP Refresher Apr 2 Completed
JLJ. LiuStudy Nurse Protocol NS-204 May 12 Overdue

Trial Master File

A TMF that's ready on day one

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.

  • Structure that maps to sponsor → study → site out of the box
  • Full version history and audit trail on every document
  • Scales from a single site to a multi-site, global investigation
See the TMF →
Deft — Trial Master File
NS-204 — Phase II AF
Inspection-ready
Sponsor — Northstar Bio 3 studies
Study NS-204 2 sites
Protocol & amendments v3.1
Site 01 — Denver 12 docs
Site 02 — Austin 9 docs

Security & compliance

Compliance built in, not bolted on

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.

  • Passwordless email login — no shared passwords to manage
  • Role-based access across sponsors, studies, and sites
  • Immutable audit trail on every signature and document change
Deft — Compliance dashboard
Training compliance
All sites
148People tracked
23Curricula
18Overdue
Completed · 72% Pending · 16% Overdue · 12%
Site 01
86%
Site 02
64%
Site 03
41%

Built for regulated trials

21 CFR Part 11 e-signatures, audit trails, and access controls are standard — so your trial stays inspection-ready from day one.

21 CFR Part 11 HIPAA SOC 2 Type I
Security & trust →

Compliant clinical ops, without the enterprise lift

See how Deft runs training and your Trial Master File in one place — live in a day.

Get a demo

See Deft on your trial

Tell us about your study and team. We'll get back within one business day.