Clinical operations consulting
Clinical operations consulting services for efficient clinical trials
An honest look at your studies, processes and readiness, with practical next steps instead of a generic report. For biotech sponsors, CROs and research teams.
Definition
What is clinical operations consulting?
Clinical operations consulting helps a team run trials more reliably. It looks at how studies are planned, started, tracked and documented, and fixes the steps that cause delay or findings.
Manakiki starts with your problem, not a fixed product. We review how the work happens today, agree a written scope, and stay involved until the change is in place.
Protocol AI is optional. Some clients use it to put the improved process into practice; others keep their current tools.
The problem
Common challenges in clinical research operations
Most problems are process problems that show up as delays or audit findings.
Deviations draw findings
Failure to follow the investigational plan, including protocol deviations, remains one of the most common FDA clinical investigator observations.
Source: U.S. FDA, Bioresearch Monitoring (BIMO) Fiscal Year 2024 Metrics
Quality must be built in
ICH E6(R3) asks teams to design quality and risk checks into trials from the start.
Source: ICH E6(R3) Guideline for Good Clinical Practice (2025)
Start-up is slow
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)
What you get
How Manakiki supports clinical operations teams
Each engagement is scoped to your study and quoted in writing before work starts.
Clinical trial workflow assessment
We map how a study or program runs today and show where time and quality are lost.
Clinical operations process improvement
Practical changes to plans, trackers and SOPs, agreed with your team and put into use.
Clinical study planning and coordination
Study start-up support for site documents, approvals, budgets and first-participant readiness.
Inspection readiness
A review of trial records, logs and SOPs, with a clear list of what to fix before an audit or inspection.
Study performance and operational oversight
Clear reporting on progress, risks and issues so leaders can act early.
Vetted clinical talent
Clinical, medical and regulatory professionals matched on experience and working style, for one role or a full team.
How it works
Where Protocol AI fits, if you choose it
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 we work with
Sponsors, CROs and research teams that want practical help from people who have run studies.
- Biotech sponsors building their first clinical operations processes.
- CROs improving consistency across studies.
- Research teams preparing for an audit or inspection.
- Teams that need extra experienced people for a defined period.
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
What does a typical engagement look like?
A short call to understand the problem, a written scope with people, timeline and price, then senior people do the work and report progress until it is done.
Do I need Protocol AI?
No. Our consulting works on its 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.
Tell us what is slowing your study down
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.