For clinical trial sponsors
Clinical research software for sponsors to streamline study management
Sponsors stay accountable for a study even when a CRO and sites do the work. Protocol AI gives your team its own protocol-based plan, so you can see progress, owners and risks without waiting for the next status report.
The reality
Clinical trial management challenges for sponsors
A sponsor is responsible for the quality and oversight of a trial, including the parts it delegates. In practice that means checking CRO and site progress against a plan the sponsor often does not control.
Many sponsor teams piece that picture together from CRO reports, emails and their own spreadsheets. When the protocol is amended, every one of those copies has to be updated by hand.
Protocol AI gives the sponsor a single plan built from the approved protocol. Milestones, tasks and risks sit in one place, and every extracted item links back to the protocol section it came from.
The problem
Improve clinical study planning and oversight
Oversight gets harder as studies grow, change and run across more partners.
Oversight stays with the sponsor
ICH E6(R3) keeps the sponsor responsible for quality and oversight of delegated trial activities.
Source: ICH E6(R3) Guideline for Good Clinical Practice (2025)
Protocols keep changing
76% of protocols need at least one amendment, and sites run on mixed protocol versions for an average of 215 days.
Delay is costly
Direct trial costs are estimated at about $40,000 per day for Phase II and III studies.
What you get
How Protocol AI supports clinical trial sponsors
The capabilities below are part of early access. Items marked roadmap are planned and confirmed per customer. General oversight practices still depend on your own procedures.
Clinical trial milestone and timeline tracking
Start-up, site activation, first patient in, interim reviews and close-out, tracked against the approved plan.
Sponsor and CRO collaboration
One shared set of milestones and tasks that your CRO and sites work against, so status questions have one answer.
Clinical trial risk and issue management
Logs for risks, issues and protocol deviations, linked to the tasks and milestones they affect.
Study performance reporting and visibility
Status and risk views built from the live plan, with exports for internal and board updates.
Audit trail
Changes recorded with user and time, so you can show who approved each part of the plan.
Risk-based quality dashboards
RoadmapDashboards that flag studies and sites needing attention.
How it works
From protocol to a plan your partners work against
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
Built for sponsor teams
Useful when the sponsor team is small and most of the work is outsourced.
- Biotech and pharma sponsors that outsource to one or more CROs.
- Clinical operations leads who need an independent view of study progress.
- Teams preparing for audits who want a clear record of decisions and approvals.
- Sponsors who want hands-on support as well as software, from one team.
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
Does our CRO have to switch systems?
No. Protocol AI gives the sponsor its own plan to measure progress against. Your CRO can keep its systems, and integrations are scoped per customer.
Which parts are product features and which are recommendations?
Items on this page without a roadmap label are part of early access. Oversight practices such as review meetings and escalation rules come from your own procedures, and our services team can help set them up.
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.