Clinical trial project management
Clinical trial project management software for better study execution
Milestones, dependencies, owners and risk logs, generated from the protocol and kept current as the study moves. Built for the project managers who hold a trial together.
1 · Extracted
Visit 3, Day 28 ± 3 days
§6.2, p. 42Approved12-lead ECG at Visits 1, 3, 6
§6.4, p. 45ApprovedPK sample, 2 h post-dose
§7.1, p. 51Needs review
2 · Study plan
Wk 0 to 80Site activation, 3 sites
CPM
First patient in
Sites
Visit 3 window tracking
CRA
PK sample logistics
Lab
Interim data review
DM
Definition
What is clinical trial project management?
Clinical trial project management is the discipline of turning a protocol into scheduled, owned work, then steering that work through start-up, enrollment, conduct and close-out.
It covers the timeline, the steps that decide when the first patient is enrolled, the budget, the risks and issues that threaten delivery, and the reporting sponsors expect.
General project tools can hold tasks, but they do not understand visits, windows or protocol amendments. Protocol AI is built around those study concepts.
The problem
Why clinical trial projects become difficult to manage
Every delay day is expensive, and most of the delay is set up before the first patient.
Each day of delay costs money
Direct trial costs are estimated at about $40,000 per day for Phase II and III studies.
Amendments are costly
A substantial amendment has a median direct cost of about $141,000 in Phase II and $535,000 in Phase III.
Plans drift from the protocol
When the plan is retyped by hand, every amendment creates another chance for the schedule and the protocol to disagree.
What you get
Plan your study from protocol to execution
Early access features for study project management. Roadmap items are confirmed per customer.
Study milestones
Start-up, site activation, first patient in, interim analyses and close-out, tracked against the approved plan.
Task ownership
Owners, due dates and status for every task, with a history of who changed what and when.
Dependencies and timeline
A timeline that shows task dependencies, so a late contract or ethics approval shows its knock-on effect right away.
Risk and issue tracking
Logs for risks, issues, decisions and protocol deviations, linked to the tasks they affect.
Clinical operations reporting
Status views and exports for sponsor updates and internal reviews, built from the same plan the team works in.
Resource forecasting
RoadmapForward views of staff workload across studies to support capacity planning.
How it works
See Protocol AI in action
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 sponsors and CROs
A shared plan replaces status meetings spent reconciling spreadsheets.
- Sponsors see progress and risk without waiting for a weekly report.
- CRO project managers start each study from the protocol instead of a copied template.
- Your team can update the approved plan after an amendment, with the history preserved.
- Leaders can trace any date in the plan back to the protocol requirement behind it.
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 use Protocol AI alongside Microsoft Project or Smartsheet?
Yes. Many teams start by running Protocol AI next to their existing tools. Plans and task lists can be exported while you decide how far to move.
Does Protocol AI show what drives our key dates?
The timeline shows dependencies between tasks and milestones so you can see what drives your key dates. Your project manager decides what goes into the approved plan.
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.