Clinical trial project management services
Clinical trial project management services for efficient study execution
A project manager who builds the plan, runs the timeline and keeps sponsors, CROs and sites on the same page. Work with our team on its own or alongside Protocol AI.
Definition
What is clinical trial project management?
Clinical trial project management turns a protocol into scheduled, owned work, then steers that work through start-up, enrollment, conduct and close-out.
It covers the timeline, the milestones that decide when the first participant is enrolled, the budget, the risks and issues that threaten delivery, and the reporting sponsors expect.
Manakiki provides project managers who do this work with your team. If you use Protocol AI, the plan they manage comes straight from your protocol.
The problem
Why clinical trial projects slip
Most delays are set up before the first participant is enrolled.
Start-up takes months
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)
Amendments ripple
An amendment takes an average of 260 days from identifying the need to the last oversight approval.
Each day of delay costs money
Direct trial costs are estimated at about $40,000 per day for Phase II and III studies.
What you get
How Manakiki supports clinical trial project management
Scoped to your study and quoted in writing before work starts.
Clinical trial planning and study coordination
A written study plan with owners and dates, agreed with your team, CRO and sites.
Timeline and milestone management
We track start-up, site activation, first participant in and close-out, and flag slippage early.
Task and resource management
Clear ownership for every task, so work does not wait on someone who did not know it was theirs.
Risk and issue management
A maintained risk and issue log with actions, owners and follow-up.
Study monitoring and reporting
Regular status reports for sponsors and leadership, built from the live plan.
Study start-up support
Help with site documents, approvals, budgets and the checklist that gets the first participant enrolled.
How it works
How Protocol AI can complement our project managers
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 project management services
Teams that need experienced hands for a study or a busy period.
- Small biotech sponsors without a full clinical operations team.
- CROs that need extra project managers for a new study.
- Research teams moving a study from spreadsheets to a structured plan.
- Sponsors who want software and services 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
Do I need Protocol AI to use your project management services?
No. Our services work on their own or alongside Protocol AI and the systems you already use.
How are services priced?
Services are scoped to your study and quoted in writing before work starts.
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.
Talk to a clinical project manager
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.