AI protocol planning
Turn clinical trial protocols into actionable study plans with AI
Upload the protocol. Protocol AI extracts the visits, procedures and milestones with a source reference for each one, and your team approves what becomes the plan. AI drafts. People decide.
1 · Extracted
Visit 3, Day 28 ± 3 days
§6.2, p. 42Approved12-lead ECG at Visits 1, 3, 6
§6.4, p. 45ApprovedPK sample, 2 h post-dose
§7.1, p. 51Needs review
2 · Study plan
Wk 0 to 80Site activation, 3 sites
CPM
First patient in
Sites
Visit 3 window tracking
CRA
PK sample logistics
Lab
Interim data review
DM
Why it is hard
Why clinical trial protocol planning is complex
A protocol can run to hundreds of pages. The schedule of activities, visit windows, eligibility checks, safety procedures and sample handling are spread across sections and appendices.
Operations teams translate all of it into tasks, timelines and budgets by hand. It is slow, it depends on a few experienced people, and it has to be repeated every time the protocol is amended.
AI is useful here for one reason: it can read the whole document quickly and propose a structured first draft. It is not a replacement for clinical judgment, so every item links back to the protocol and gets reviewed.
The problem
The cost of getting the plan wrong
Planning errors become amendments, deviations and delay.
Most protocols are amended
76% of protocols need at least one amendment, averaging 3.3 amendments each.
Delays are expensive
A day of delay is estimated at about $500,000 in lost sales, on top of about $40,000 in direct trial costs.
Deviations are a top finding
Not following the investigational plan is among the most common FDA clinical investigator observations.
Source: U.S. FDA, Bioresearch Monitoring (BIMO) Fiscal Year 2024 Metrics
What you get
From protocol upload to study plan
Each step below is part of early access. The AI output is always a draft for review.
Protocol document upload
Start from the approved protocol in PDF or Word. Early access studies should use de-identified documents.
AI extraction of visits and procedures
Visits, windows, procedures, eligibility points and milestones, each linked to its section and page in the protocol.
Study tasks and milestone generation
Approved items become a timeline and task list with suggested owners.
Team review and execution
A named reviewer accepts, edits or rejects every item. The approved plan becomes the plan the study runs on.
Amendment comparison
RoadmapHighlights what changed between protocol versions and which tasks and dates are affected.
Recorded demonstration
RoadmapA walkthrough using a de-identified sample protocol. Until it is published, the live demo shows the full flow.
How it works
From protocol upload to a reviewed study plan
Automation does the first draft. People make every decision that matters.
01
Upload the protocol
Start from the approved protocol PDF or Word file. Or hand it to our team during guided onboarding. No blank setup and no retyping the schedule of activities.
02
AI pulls out the study details
Visits, windows, procedures, eligibility points and milestones are pulled out, each linked to the section and page it came from.
03
Your team reviews and approves
A project manager or clinical lead accepts, edits or rejects each item. Nothing enters the plan without a named reviewer.
04
The study plan is generated
Approved items become a timeline, a task list with owners and a starting budget.
05
Run the study in one place
Track tasks, milestones, risks, issues and deviations as the study moves, with a history of who changed what.
Generated automatically
Draft extraction of visits, windows, procedures and milestones, each with a protocol section reference, plus a draft timeline and task list.
Requires human review
Every extracted item, every task owner and date, and the approved plan itself. Nothing is used until a named reviewer approves it.
Fit
Benefits of AI-assisted protocol planning
Faster first drafts, with traceability that makes the plan easier to trust.
- A structured first draft of the plan for your team to review.
- Every task traces back to a protocol requirement, which makes review faster.
- Less dependence on one experienced person who knows where everything is.
- A consistent starting structure across studies, which helps CROs and portfolio teams.
Compliance
Documentation and compliance, stated plainly
Protocol AI keeps an audit trail of changes with user and time, limits access by role, and links every extracted item to its source in the protocol. It is designed to support 21 CFR Part 11 controls and the sponsor oversight expected under ICH E6(R3), showing who approved each part of the plan.
Compliance also depends on your procedures, so formal system validation is completed with each regulated customer rather than claimed in advance. Read the security and compliance overview for details.
FAQ
Frequently asked questions
Which outputs are generated automatically and which need review?
Protocol AI drafts the extracted visits, windows, procedures and milestones, and a draft timeline and task list. Every one of those items, every owner and date, and the final approved plan require approval by a named person on your team.
What file types can I upload?
PDF and Word protocol documents. Scanned images with poor quality may need manual review of more items.
Is my protocol used to train AI models?
Data handling is agreed in writing before any customer document is uploaded. Early access studies should use de-identified protocols. Ask us for the current data processing terms during your demo.
How much does Protocol AI cost?
Pricing depends on your study, number of sites and the support you need. Book a demo or contact us and we will send a clear quote.
Bring a protocol and see the draft plan
Bring a protocol, or use our sample study. In 30 minutes you will see the extracted schedule, the generated plan and what your team reviews before anything goes live.