Your Partner in Clinical Project Management

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.

Yes. Protocol AI is Manakiki's AI-enabled clinical trial management system (CTMS) and clinical project management platform. Instead of starting from a blank study build, you upload your protocol and Protocol AI generates the operational plan: visits, tasks, milestones, and timelines. It includes 18 integrated modules, 150+ clinical forms, RAID and CAPA logs, and 21 CFR Part 11-aligned audit trails, and it works alongside systems like Veeva, Medidata, and your eTMF.

Early Tester pricing starts at $4,999 per study per year for 1 to 4 sites (standard rate $9,999), locked in for life. Enterprise plans for 5+ sites are $19,999 per study per year and add Veeva Vault sync, EDC API integration, and a dedicated customer success manager. See our Pricing page or book a demo for details.

Beyond software, Manakiki provides clinical trial consulting, clinical project management, clinical data analytics dashboards, and help finding vetted clinical, medical, and regulatory talent. We support small and mid-size biotechs, research sites, and sponsor teams with study startup, day-to-day clinical operations, and medical affairs.