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Protocol AI · Early access

Protocol AI: from protocol to a study plan your team approves

Upload the protocol. Protocol AI drafts the plan, your team checks each item against the source, and the study runs from one shared plan.

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Protocol AI · Study MK-SAMPLE-201

1 · Extracted

  • Visit 3, Day 28 ± 3 days

    §6.2, p. 42Approved

  • 12-lead ECG at Visits 1, 3, 6

    §6.4, p. 45Approved

  • PK sample, 2 h post-dose

    §7.1, p. 51Needs review

2 · Study plan

Wk 0 to 80

  • Site activation, 3 sites

    CPM

  • First patient in

    Sites

  • Visit 3 window tracking

    CRA

  • PK sample logistics

    Lab

  • Interim data review

    DM

1 item waiting for reviewer sign-off before it enters the plan.
Illustrative example with sample data. Your demo uses a real or sample protocol of your choice.

How it works

Five steps, with people in control

  1. 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.

  2. 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.

  3. 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.

  4. 04

    The study plan is generated

    Approved items become a timeline, a task list with owners and a starting budget.

  5. 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.

Features

What is ready and what is planned

We label every feature, so you know what you get today.

Early access

AI-assisted protocol extraction

Pulls visits, windows, procedures and milestones from the protocol with a source reference and a review status for every item.
Early access

Study plan and timeline

Builds a timeline and task list from approved protocol items, with key milestones and task dependencies.
Early access

Tasks and ownership

Every task has an owner, a due date and a status, so sponsors, CROs and sites see the same picture.
Early access

Budget tracking

A starting budget view tied to the plan, so cost questions are answered from the same source as timeline questions.
Early access

Risk, issue and deviation logs

Logs for risks, issues and protocol deviations, linked to the tasks and milestones they affect.
Early access

Clinical forms library

More than 150 clinical operations forms are being turned into editable, versioned templates.
Early access

Audit trail and role-based access

Changes are recorded with user and time. Access is limited by role. Designed to support 21 CFR Part 11 controls.
Roadmap

Integrations with Veeva, Medidata and eTMF

Connections to your existing EDC, eTMF and CTMS are scoped per customer. Until then, exports keep data moving.
Roadmap

Risk-based quality dashboards

Dashboards that flag studies and sites needing attention, to support risk-based quality work.

Good to know before you start

  • Protocol AI is in early access. Feature availability is confirmed in writing for each customer before work starts.
  • AI extraction is a draft for human review, not a final answer. Every item is checked by your team before it is used.
  • Protocol AI is designed to support 21 CFR Part 11 and GCP expectations. We do not claim validated or Part 11 compliant status. Before regulated use, validation and controls are assessed and agreed with you.
  • Do not upload identifiable participant information during early access. Any future handling of health information needs the right agreements, including a BAA where required, and verified security controls first.

Questions

What does Protocol AI do?

It reads your protocol, drafts the schedule, tasks and milestones with a link to the source page for each item, and lets your team approve them. The approved plan is then used to track the study.

Is Protocol AI available today?

Protocol AI is in early access. Features marked early access are shown in demos. Roadmap items are planned or scoped per customer, and we confirm what is included in writing before work starts.

How much does it 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.

Book a demoContact us for pricing
Prefer email? Write to jmodi@manakiki.net. A person replies, usually within one business day.