Clinical trial data analytics
Clinical trial data analytics for smarter research decisions
Clear reporting that brings study, site and operations data together so your team can see what is on track and act on what is not. Delivered by our team, with Protocol AI as the plan data source if you use it.
Definition
What is clinical trial data analytics?
Clinical trial data analytics, in an operations sense, means using study data to understand progress: which milestones are on time, which sites are behind, which risks are open and where cost is moving.
It is different from statistical analysis of trial results. The goal here is operational decisions, made earlier and with better information.
Manakiki builds these reports and dashboards for your studies. If you use Protocol AI, the live plan provides the milestones, tasks, risks and deviations the reports are based on.
The problem
Why data-driven clinical trial management matters
Late information is expensive information.
Delay is costly
Direct trial costs are estimated at about $40,000 per day for Phase II and III studies.
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)
Risk-based oversight is expected
ICH E6(R3) asks sponsors to focus oversight on the risks that matter most to participants and data.
Source: ICH E6(R3) Guideline for Good Clinical Practice (2025)
What you get
How Manakiki supports clinical trial analytics
Analytics services are scoped per study. Protocol AI features are early access unless marked roadmap.
Clinical trial performance monitoring
Reports that show progress against the approved plan, by study and by site.
Study milestone and progress reporting
Regular milestone reports for sponsors and leadership, with slippage called out early.
Clinical operations metrics and KPIs
A short set of measures agreed with your team, such as start-up time, open risks and deviation counts.
Data visualization and dashboards
Clear dashboards built by our team from your study, site and operations data.
Protocol AI status views and exports
Status and risk views from the live plan, with structured exports for reporting.
Built-in cross-study dashboards in Protocol AI
RoadmapOne in-product view of risk across all your studies.
How it works
Where the data comes from in Protocol AI
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 uses our analytics services
Teams that have the data but not the time to turn it into clear decisions.
- Sponsors who want an independent view of CRO and site performance.
- CROs that need consistent reporting across studies.
- Leadership teams preparing board or investor updates.
- Research teams moving from spreadsheet reports to dashboards.
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
Is this statistical analysis of trial results?
No. This service covers operational analytics: progress, timelines, risks, deviations and cost. Statistical analysis of efficacy and safety data is a separate discipline.
Do we need Protocol AI for analytics?
No. We can work from your existing trackers and systems. Protocol AI makes the plan data more structured when you use it.
How are services priced?
Services are scoped to your study and quoted in writing before work starts.
See your study data more clearly
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.