Protocol AI · Early access
AI clinical trial management software that starts with your protocol
Upload your protocol and get a draft schedule, task list and budget, each item linked to its source. Run the study yourself, or lean on our clinical operations team for start-up, project management and inspection readiness.
- Every AI-extracted item links to its protocol section
- Works alongside your EDC, eTMF and CRO
- Clinical operations team on hand when you need it
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 trials slip
Most delays start before the first patient
Start-up is slow, protocols change often, and every day costs money. Turning a protocol into a plan is still mostly manual.
- 31.4 weeks
- from site identification to study start-up, about a month longer than a decade ago
- 76%
- of protocols in a 2022 industry sample had at least one amendment, averaging 3.3 each
- 260 days
- on average from identifying the need to amend to the last oversight approval
- ~$40,000
- direct cost per day of running a Phase II or Phase III trial
Sources: WCG, Decoding the Top Site Challenges of 2024: Study Start-Up (2024); Getz K, Smith Z, Botto E, et al. New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance. Ther Innov Regul Sci. 2024;58:539-548; Smith ZP, DiMasi JA, Getz KA. New Estimates on the Cost of a Delay Day in Drug Development. Ther Innov Regul Sci. 2024;58(5):855-862.
How it works
From protocol to a plan your team trusts
Five steps, with a person in control at the point 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.
Why Manakiki
A solution partner, not one-size-fits-all software
We start from your protocol, offer guided onboarding and stay to help while the study runs.
One-size-fits-all software
- Setup is a project of its own before the first study starts.
- Your team rebuilds each study by hand in a blank system.
- Support ends at the software. Your team is on its own.
Manakiki
- Your protocol becomes the first draft of the plan, and your team approves it.
- Pricing matched to your study and the support you need.
- Clinical operations staff who can help with project management, study start-up and inspection readiness.
Where it fits
Simpler than enterprise systems, more organized than spreadsheets
| Spreadsheets and email | Traditional CTMS | Protocol AI | |
|---|---|---|---|
| Starting point | Blank sheets and copied tables | Built and configured for each study | Your approved protocol |
| Setup effort | Low to start, high to maintain | Implementation project | Guided onboarding per study |
| Link back to the protocol | Manual | Varies by configuration | Every item links to its protocol section |
| Built for | Any team | Large sponsors and CROs | Small sponsors, CROs and research teams |
| Pricing | Staff time | Enterprise contracts | Quoted per study |
General comparison of approaches. Capabilities vary by product and setup.
Compare Protocol AI with Veeva, Medidata, CliniOps and MedrioSolutions
Built around how your team actually works
Pick the starting point closest to your role. Each page explains the workflow, what Protocol AI does and what it does not do yet.
- Clinical trial management softwareCTMS built around the protocol, not a blank study build.
- Clinical trial project managementMilestones, dependencies, owners and risk logs.
- AI protocol planningFrom protocol PDF to a reviewed study plan.
- Clinical research managementCoordination and visibility for research teams.
- For biotech sponsorsSponsor oversight without a large operations team.
- For CROsRepeatable delivery across sponsors and studies.
Questions
Straight answers
What is Protocol AI?
Protocol AI is Manakiki's AI-assisted clinical trial management software (CTMS). You upload a protocol, the software extracts visits, procedures and milestones with a source reference for each one, your team reviews them, and the approved items become a study plan with tasks, owners, timeline and budget tracking.
Who is it built for?
Small and mid-size biotech sponsors, CROs running studies for several sponsors, and research teams that need clear oversight without a large operations department or a long enterprise implementation.
Is Protocol AI an alternative to Veeva, Medidata or Medrio?
Yes, for small and mid-size studies that need clear oversight without an enterprise contract or a long setup. If you or your CRO already use one of those systems, Protocol AI can also run alongside it. Exports work today, and integrations are scoped per customer.
Is the AI output used without review?
Never. Every extracted item shows where it came from in the protocol and stays in a review state until a named person approves 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 such as 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 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.