For CROs
Clinical trial management software for CROs
Repeatable delivery across sponsors and studies. Protocol AI builds each study plan from the sponsor's protocol, so your project managers start from a structured draft instead of last year's template.
The reality
Clinical operations challenges for CROs
CRO teams run many studies at once for sponsors who each expect clear reporting and fast answers. Project managers move between protocols, therapeutic areas and sponsor preferences every day.
Much of the start-up effort is the same translation work repeated for every new protocol: reading the schedule of activities, building the timeline, assigning owners and setting up trackers.
Protocol AI makes that first draft faster and more consistent, and keeps a record of how each part of the plan ties back to the protocol.
The problem
Where CRO delivery gets squeezed
Sponsors want speed and transparency, and protocols keep changing mid-study.
Amendments are frequent
Protocols average 3.3 amendments, and sites run on mixed versions for an average of 215 days.
Start-up is long
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)
Deviations draw findings
Failure to follow 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
Manage multiple studies and project workflows
Early access capabilities for CRO teams. Roadmap items are confirmed per customer.
Study milestone and task management
Milestones, owners and dependencies for every study, generated from the protocol and approved by your PM.
Sponsor and site coordination
Shared milestones and task status that sponsors and sites can review, reducing reconciliation calls.
Reporting and oversight
Status and risk views built from the live plan, with exports for sponsor reports.
Consistent study structure
Every study starts from the same structured approach, which makes handovers between PMs easier.
Audit trail
Changes recorded with user and time, and extracted items linked to protocol sections.
Sponsor portals and multi-tenant reporting
RoadmapDedicated sponsor-facing views across a CRO portfolio.
How it works
How Protocol AI supports CRO teams
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
A partner, not a replacement
Protocol AI is designed to work with the systems and processes a CRO already has.
- Use it for planning and tracking while your EDC and eTMF stay in place.
- Pilot on one study before rolling out further.
- Integrations with existing CTMS, EDC and eTMF platforms are scoped per customer.
- Manakiki can also provide clinical operations support when your team is stretched.
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
Can we run Protocol AI for several sponsors?
Yes. Pricing is per study, so each sponsor study is set up and billed separately. Access is limited by role so each sponsor sees only its own study.
Will we have to move off our current CTMS?
No. Protocol AI can support planning alongside an existing CTMS. Integration is scoped per customer, and exports cover the gap until then.
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.
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.