Clinical trial management software
AI-powered clinical trial management software
Protocol AI is a CTMS that starts from your approved protocol instead of a blank study build. It drafts the schedule, tasks and milestones, your team approves each item, and the study runs from one traceable plan.
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
Definition
What is clinical trial management software?
A clinical trial management system (CTMS) is the main record of a study. It holds the plan, the milestones, who owns each task, how sites are progressing, what the study costs and which risks and deviations need attention.
Most CTMS platforms expect your team to build all of that by hand. Someone reads the protocol, retypes the schedule of activities into spreadsheets, and then keeps every copy in sync as amendments arrive.
Protocol AI changes the starting point. The protocol itself becomes the source for the plan, and every extracted item keeps a link back to the section it came from, so the plan stays explainable when the protocol changes.
The problem
Planning by hand is where trials lose time
The cost of slow, manual planning shows up in start-up time, amendments and inspection findings.
Start-up takes months
Sites report an average of 31.4 weeks from site identification to study start-up.
Source: WCG, Decoding the Top Site Challenges of 2024: Study Start-Up (2024)
Protocols keep changing
76% of protocols need at least one amendment, and sites run on mixed protocol versions for an average of 215 days.
Deviations draw findings
Failure to follow the investigational plan, including protocol deviations, remains one of the most common FDA clinical investigator observations.
Source: U.S. FDA, Bioresearch Monitoring (BIMO) Fiscal Year 2024 Metrics
What you get
Key features of Protocol AI
The modules below are part of early access. Items marked roadmap are planned and confirmed per customer.
AI-powered protocol analysis
Extracts visits, windows, procedures and milestones from the protocol PDF or Word file, each with a section and page reference.
Automated study planning
Approved items become a timeline, a task list with owners and the key milestones.
Milestone management
Track start-up, first patient in, interim reviews and close-out against the approved plan, with slippage visible early.
Site and visit tracking
Site activation milestones and the visit schedule from the protocol, so sponsors, CROs and sites see the same dates.
Budget, risk and deviation logs
A starting budget view tied to the plan, plus logs for risks, issues and deviations linked to the work they affect.
EDC, eTMF and CTMS integrations
RoadmapConnections to Veeva, Medidata and eTMF platforms are scoped per customer. Until then, structured exports keep data moving.
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
Who should use Protocol AI?
Teams that need a proper system without a long enterprise implementation.
- Small and mid-size biotech sponsors running their first or second clinical program.
- CROs delivering studies for several sponsors at once.
- Academic and research teams that manage trials in spreadsheets today and need oversight they can trace to the protocol.
- Clinical project managers who want the plan to update from the protocol, not from memory.
Compliance
Clinical trial compliance and documentation
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
What is the difference between a CTMS and an EDC?
An EDC captures subject-level clinical data for analysis. A CTMS manages the operations around the study: plans, milestones, sites, tasks, budgets, risks and deviations. Protocol AI is a CTMS and is designed to sit alongside the EDC you already use.
Is Protocol AI an alternative to Veeva or Medidata?
Yes, for small and mid-size sponsors and CROs that do not need a large enterprise platform. If you already use Veeva or Medidata, Protocol AI can run alongside it, and integrations are scoped per customer.
Is anything generated by AI used without review?
No. Each extracted item shows the protocol section it came from and stays in review until a named person approves, edits or rejects it. Only approved items enter the approved plan.
Is Protocol AI 21 CFR Part 11 compliant?
Protocol AI is designed to support 21 CFR Part 11 controls, including audit trails, role-based access and attributable changes. We do not claim validated or Part 11 compliant status. Before regulated use, validation and controls are assessed and agreed with you for your intended use.
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.
See your own protocol turned into a 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.