For biotech sponsors
Clinical trial management software built for biotech companies
Sponsor oversight for small teams. Protocol AI turns your protocol into a plan you can hold your CRO and sites to, without an enterprise implementation project.
The reality
Clinical trial challenges for growing biotech companies
Most small biotech companies run clinical programs with a handful of operations staff and an outsourced CRO. The sponsor is still accountable for oversight under GCP, even when the work is delegated.
That usually means a sponsor team reconciling CRO reports against spreadsheets, without a system of its own that shows whether the study is on plan.
Protocol AI gives the sponsor that system. The plan comes from the protocol, the CRO and sites work against the same milestones, and the sponsor sees progress and risk directly.
The problem
Manage studies without adding complexity
Every month of delay matters more when the runway is finite.
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)
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)
What you get
How Protocol AI supports biotech teams
Early access capabilities for sponsor teams. Roadmap items are confirmed per customer.
Clinical trial planning and execution
A reviewed plan generated from your protocol, with milestones, owners and dependencies.
CRO and site oversight
One shared set of milestones and tasks, so you see progress without waiting for the next status report.
Budget visibility
A starting budget view tied to the plan, so timeline and cost questions are answered from the same source.
Risk and deviation logs
Risks, issues and deviations recorded against the work they affect, with an audit trail of changes.
Flexible clinical operations support
Need hands-on help as well? Manakiki's clinical operations team can support start-up, project management and inspection readiness.
Investor and board reporting views
RoadmapProgram-level summaries suitable for board updates.
How it works
Clinical trial planning and execution
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
Practical adoption for small teams
Guided onboarding tailored to your team and study.
- Pricing scaled to your study, with no long implementation project.
- Guided onboarding per study, starting from your protocol.
- Works beside your CRO and their systems rather than asking them to switch.
- Software and services from one team when you need extra hands.
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
We outsource to a CRO. Why do we need our own system?
The sponsor keeps responsibility for oversight even when work is delegated. Protocol AI gives you an independent, protocol-based plan to measure CRO and site progress against, without asking the CRO to change its own systems.
How long does it take to get started?
Onboarding is guided per study. The first step is uploading the protocol and reviewing the extracted items with your team, which we walk through together.
Is Protocol AI 21 CFR Part 11 compliant?
Protocol AI is designed to support 21 CFR Part 11 controls, including 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 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.