Turn complex protocols into clear execution plans with Protocol AI and experienced clinical operations support, so studies move faster, cost less, and stay inspection-ready.
Turn complex protocols into clear execution plans with Protocol AI and experienced clinical operations support, so studies move faster, cost less, and stay inspection-ready.
Protocol AI helps clinical teams move from protocol to execution in minutes. Upload a protocol, generate an operational plan, and manage study startup, sites, monitoring, TMF activities, adverse events, and reporting with a workflow built for compliant clinical trial execution.
Our mission is to help clinical, regulatory, and medical affairs teams reduce friction, improve study execution, and bring promising therapies to patients faster through practical workflow design and Protocol AI.
We believe trial execution should be faster, clearer, and more accountable. By combining human judgment with explainable AI, we help teams plan better, coordinate faster, and deliver studies with stronger operational control.
Manakiki works alongside sponsors, CROs, and internal teams to solve operational bottlenecks in clinical trials. We support clinical operations, medical affairs, and regulatory work with practical execution support and Protocol AI-driven planning rather than forcing teams to replace the systems they already use.
Our founders focus on complex healthcare execution problems where speed, compliance, and coordination matter. That perspective shaped Protocol AI and our hands-on approach to helping teams manage trial operations with precision and accountability.
A few things teams often ask us. If your question isn't here, reach out anytime at jmodi@manakiki.net and we'll be glad to help.
We help teams run clinical trials more easily. We do this in two ways: software and support. Our software, Protocol AI, manages the whole trial in one place, and our analytics turn your trial data into clear dashboards. On the support side, our team can help with day-to-day clinical operations and medical affairs. You can use just the software, just the support, or both.
Mostly small and mid-size biotechs and research teams who need the kind of control big sponsors have, but without a huge budget or a large operations team. If you are running trials and want to stay organized, compliant, and on schedule, we built this for you.
You drop in your protocol and Protocol AI turns it into a clear, working plan. It maps out visits, tasks, and timelines, flags what needs attention, and keeps your documents and data organized in one place. Across its modules it covers study setup, sites, participants, visits, safety, supplies, and reporting, so your team spends less time on busywork and more time on the trial itself.
We want to change how Clinical Affairs, Medical Affairs, and Regulatory Affairs work day to day. These teams carry a lot of the weight in bringing a drug to patients, yet they often lose time to manual steps, scattered data, and slow handoffs. Our goal is simple: make pharma teams more efficient so good medicines reach the market faster and at a lower cost. When trials run smoothly and decisions are backed by clear data, patients wait less and resources go further.
Yes. Beyond running trials, we help Medical Affairs and Regulatory Affairs teams work faster and with less friction. That means cleaner data for evidence and publications, clear records for submissions, and tools that keep everyone aligned on compliance and governance. The aim is always the same: fewer delays, lower cost, and a quicker path to approval so treatments reach the people who need them.
We will tell you honestly. If we do not know something, we will say so rather than guess. Then we roll up our sleeves and do everything possible to find the answer and a real solution for you, whether that means digging into the data, bringing in the right expert, or building something new. You will always know where things stand, and we will not stop until your problem is sorted out.
No. We are not here to replace the platforms or partners you trust, like Veeva Vault, Medidata, CliniOps, PIhealth.ai, or your CRO. We are the project management team that helps you get the most out of them. Think of us as problem solvers who sit on your side of the table, connecting your tools, your data, and your people so the whole project moves forward. Our only goal is to make your trial successful.
Tell us what study, protocol, or operational challenge you are working on, and we will show you how Protocol AI and targeted clinical operations support can help move it forward. A real person will respond.
Today | Closed |
Copyright © 2026 Manakiki - All Rights Reserved.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.