Protocol and eCRF guidelines go in; eSource forms and visit schedules come out in minutes, ready for your team’s review.
ProtoScribe gives your Protocol a Head Start
Built with these standards in mind
Is manual eSource form building still slowing your sites down?
Traditionally, teams read the protocol line by line, then build every eSource form and visit schedule by hand. The work is slow, repetitive, and easy to get wrong, and the whole process commonly takes a week or more before sites can begin collecting patient data.
Read the protocol
Build forms manually
Map visit schedules
Review and fix
Sites start late
The ProtoScribe difference.
ProtoScribe writes the forms; your team reviews them.
- No hand-built forms
- Visit schedules included
- Review, then use
Book a Consultation
Your protocol,
made study-ready.
ProtoScribe turns requirements written in your study documents into eSource forms and visit schedules, so your team begins with a draft.
Fully usable
ProtoScribe is more than a generator: it builds your eSource forms, then holds the data your study collects with them.
ProtoScribe vs EDC
In many workflows, EDC receives data transcribed from source notes, while eSource captures the original record electronically during the visit.
ALCOA+ and ProtoScribe
Recording data as it happens supports integrity from the first entry.
Made for regulated study teams.
Forms generated from your protocol give study teams a consistent, reviewable foundation from day one.
FDA eSource
Teams following FDA eSource guidance begin with electronic forms ProtoScribe generates from your study documents.
21 CFR Part 11
ProtoScribe gives teams consistent forms to review and test during their Part 11 validation work.
ICH E6(R3)
Teams applying ICH E6(R3) get forms ProtoScribe builds straight from their protocol and eCRF guidelines.
CDISC standards
ProtoScribe reads your eCRF guidelines, so teams using CDISC conventions can carry them into forms.
How It Works
Four simple steps take you from protocol to data collection.
Add the protocol, plus your eCRF guidelines for greater accuracy, so ProtoScribe can begin building.
ProtoScribe reads your documents and builds the eSource forms and visit schedule for your study.
Check each form and visit schedule against the protocol, adjusting anything your team wants changed.
Use the approved eSource for enrolled patients, with data collected directly in each patient’s profile.
Every role, before and after ProtoScribe.
For Clinical Data Managers
Focus on the data instead of building forms.
Before
- Translating the protocol into forms field by field.
- Checking every form against eCRF guidelines by hand.
- Catching avoidable transcription mistakes late in the review.
After
- Draft forms arrive generated from your study documents.
- Your eCRF guidelines sharpen every generated form’s accuracy.
- More time for data review and study planning.
For Study Startup Managers
Stop letting form builds set your startup pace.
Before
- Data collection start dates depend on manual builds.
- Chasing updates from whoever is building the forms.
- Sites waiting on forms before they can begin.
After
- Forms and schedules ready for review almost immediately.
- Startup timelines no longer wait on form builds.
- One less handoff between protocol and data collection.
For Research Coordinators
Record visits in forms that match the protocol.
Before
- Transcribing paper notes into a system after visits.
- Forms that don’t always follow the visit schedule.
- Unsure whether a form reflects the latest protocol.
After
- Each form follows the protocol’s visit schedule closely.
- Visit data is entered directly in electronic forms.
- Confidence that every form reflects the current protocol.
For Quality Assurance Leads
Review forms against the protocol with fewer surprises.
Before
- Comparing every hand-built form against the protocol manually.
- Finding inconsistencies between forms late in the startup.
- Varying form quality depending on who built them.
After
- Every form starts from the same source documents.
- Effort shifts from rebuilding forms to verifying them.
- Fewer mismatches between the protocol and finished forms.
Why should you choose ProtoScribe?
Same protocol, three routes, and only one finishes in minutes.
Build time
Team effort
Consistency
Data collection
Manual form building
Longest, built by hand
High, fully manual
Varies by builder
Needs a separate system
Outsourced build service
Depends on their queue
Moderate, briefing and reviews
Depends on the provider
Depends on the provider’s setup
ProtoScribe
Minutes
Review and adjust
Study Documents Generated
Built into the same app
Why should you choose ProtoScribe?
Same protocol, three routes, and only one finishes in minutes.
Ready to put your protocol to work?
Talk with our team about your upcoming protocols and find out how much of the form-building stage you can hand over, starting with your next study and every study after it.
Start With ProtoScribe
Imagine study startup but without manual form building.
Protocols vary, but the work of turning them into forms is surprisingly similar every time. ProtoScribe takes on that repeatable translation, leaving your experts free to focus on judgment calls, data strategy, and the questions only your people can answer, study after study.
-
Same every time
Every form is built the same way, regardless of who reviews it.
-
Handle more studies
Take on more studies without growing the team building forms.
-
Quicker site starts
Sites can begin sooner once forms stop being the bottleneck.
30
% ↑
Faster eSource form generation
25
% ↓
Less manual building effort
40
% ↑
Earlier data collection
Frequently asked questions
What is ProtoScribe?
ProtoScribe reads a clinical trial protocol and generates the eSource forms and visit schedules for the study, which your team then uses to collect patient data in the app.
What does ProtoScribe need to get started?
A study protocol is enough to generate eSource forms and visit schedules. Adding your eCRF guidelines brings the forms to the level of accuracy a study requires.
How long does it take to generate forms?
Minutes. Building the same forms and schedules by hand typically takes a week or more.
Can my team collect data in ProtoScribe itself?
Yes. Enrolled patients appear in the app, and the eSource built for their study is where their data is recorded. The eSource can also be exported as a PDF.
Does my team still review the forms?
Yes. ProtoScribe generates the forms and visit schedules, and your team reviews and adjusts them before they are used.
