Clinical research management
Clinical research management software for modern research teams
Bring study plans, tasks, site coordination and documentation into one workspace. Protocol AI gives research teams the visibility of a CTMS without forcing them through a large enterprise implementation.
In one place
Manage clinical research operations in one place
Clinical research management is broader than running a single trial. Research teams juggle several studies, investigators, coordinators, sponsors and review boards, often with shared staff and tight budgets.
A CTMS focuses on the execution of a specific trial. Clinical research management software adds the coordination layer around it: who is working on what, which studies are at risk, and which documents are current.
Protocol AI covers both. Each study is built from its protocol, and the team view shows tasks, owners and milestones across every study you run.
The problem
Challenges in clinical research management
Research teams rarely fail for lack of expertise. They lose time to coordination.
Information lives everywhere
Plans in spreadsheets, decisions in email, and protocol versions in shared drives make it hard to know what is current.
Amendments ripple slowly
An amendment takes an average of 260 days from identifying the need to the last oversight approval.
Oversight expectations are rising
Updated good clinical practice guidance (ICH E6(R3)) asks teams to build quality and risk checks in from the start.
Source: ICH E6(R3) Guideline for Good Clinical Practice (2025)
What you get
Clinical research management features
Each feature below is part of early access unless marked roadmap.
Study planning and tracking
Plans generated from each protocol, with milestones and a timeline your team approves before it goes live.
Team and task management
Every task has an owner, a due date and a status. Workload is visible across studies, not just inside one.
Site coordination
Site activation milestones and visit schedules shared between sponsors, CROs and site staff from one source.
Documentation and reporting
An audit trail of changes, protocol section references for extracted items, and exports for status reports.
Clinical forms library
More than 150 clinical operations forms are being turned into editable, versioned templates.
Cross-study dashboards
RoadmapOne view of risk across all your studies.
How it works
How Protocol AI supports clinical research
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
Benefits for clinical research teams
Less time rebuilding plans, more time on the science and the participants.
- One current version of each study plan, linked to the protocol.
- Clear ownership, so nothing waits on a person who did not know it was theirs.
- Faster response to amendments, because changes start from the source document.
- Records that are easier to explain to sponsors, auditors and review boards.
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
How is clinical research management software different from a CTMS?
A CTMS focuses on executing an individual trial. Clinical research management software also covers coordination across studies and teams. Protocol AI does both by building each study from its protocol and showing work across studies in one place.
Can academic or investigator-initiated studies use Protocol AI?
Yes. Teams running investigator-initiated or academic studies often benefit most, because they usually manage trials in spreadsheets. Early access studies should use de-identified data.
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.