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.

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 →
SOP-014 · Sample handling
Draftediting Pending approvalawaiting reviewer Approvedready to publish PublishedPending
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, with autosave, version control, inline review comments, and a Draft → Approved → Published trail, all built in.

See document control →
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 →
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 that is email-verified, PIN-confirmed and timestamped. The meaning of every signature is captured.

See e-signatures →
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 →
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.

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 with email verification plus a signature PIN
  • Live status across every site, exportable for inspection
See training management →
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 →
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, so there are no shared passwords to manage
  • Role-based access across sponsors, studies, and sites
  • Immutable audit trail on every signature and document change
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.