Early access ProtocolScribe eSource is onboarding clinical research teams — join the waitlist.
ProtocolScribe eSource

Protocol-driven source documentation for clinical research.

Build compliant source workflows faster, reduce documentation burden, and improve protocol adherence with configurable eSource tools designed around the protocol.

Configurable across therapeutic areas · 21 CFR Part 11 · ICH-GCP E6(R3) · HIPAA · GDPR
Protocol-drivenBuilt around your protocol
Faster startupSource workflows in days
Less burdenConfigurable, reusable components
Audit-readyALCOA+ by design
The ProtocolScribe Studio

Source workflows, configured around the protocol.

Assemble pre-validated components into clean visit worksheets — structured fields, edit checks, and validation — then publish them to your sites.

app.protocolscribe.com/studio
Studio
Component Library pre-validated
⋮⋮Informed Consent✓ validated
⋮⋮Vitals Block✓ validated
⋮⋮Lab Panel✓ validated
⋮⋮PK Sampling✓ validated
⋮⋮ePRO / eCOA✓ validated
⋮⋮Adverse Events✓ validated
Visit 3 · Cycle 1 Day 1 — WorksheetDraft
Informed Consent✓ verified
Vitals Block✓ verified
Lab Panel✓ verified
PK Sampling✓ verified
Pre-dose+1h+2h+4h
Validation
Validation Logic
0%
Verifying…
  • Edit checks bound
  • Protocol ranges set
  • Audit trail enabled
  • E-signatures active
● Published to 3 study sites

Configure source workflows around your protocol — structured fields, edit checks, and validation, assembled into clean visit worksheets. Reusable, pre-validated components mean less documentation burden and tighter protocol adherence.

Why ProtocolScribe

Designed around the protocol, built for the site.

Configurable eSource that supports clinical trials across therapeutic areas — with oncology as an early use case.

01

Build compliant workflows faster

Stand up source worksheets from pre-validated, protocol-driven components — compliant structure from day one, without building forms field by field.

02

Reduce documentation burden

Configurable, reusable components and smart defaults cut repetitive data entry and transcription, so coordinators spend less time on paperwork and more with patients.

03

Improve protocol adherence

Because the source is generated from the protocol, visit windows, required assessments, and edit checks are built in — keeping every site aligned to the plan.

Compliance by design

Built for global regulatory scrutiny.

A deterministic, human-verified architecture engineered for clean data traceability — from source at the point of care through to your electronic submissions.

FDA 21 CFR Part 11

Complete data governance with computer-generated, time-stamped audit trails, secure user-permission hierarchies, and cryptographic electronic signatures.

ICH E6(R3) & Quality by Design

Strict validation rules embedded in pre-validated components weave proactive, risk-based quality management into the site workflow — aligned with the latest 2026 guidance.

ALCOA+ Data Integrity

Attributable, Legible, Contemporaneous, Original, and Accurate data capture at the point of care — backed by endurance and availability standards.

21 CFR Part 11 Compliant ICH GCP E6(R3) HIPAA Secure GDPR
Get started

See ProtocolScribe eSource on your protocol.

Secure your study runway. Join the waitlist for upcoming 2026 / 2027 trials, or request a walkthrough on your own protocol.

View Demo
Thanks — you're on the list. Our team will be in touch.
A named clinical data lead responds to every request. No bots, no call-center queue.