Trial Activation Intelligence

The Regulatory Intelligence Layer for Clinical Trial Activation

Before a single patient is enrolled, every trial carries a set of regulatory control obligations. Most sponsors cannot say how many they have, or how many are already covered. Celina determines the obligations, assesses them against risk, and generates the procedures that close the gaps. A named human signs the result.

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See how it works

For Sponsors

A determination on your protocol before you have exposure to what it finds

See sponsor solutions

For CROs

White-label activation intelligence under your brand

See CRO solutions

For Sites and Networks

Co-created evidence, published with attribution

See site solutions

The Activation Bottleneck Costs $37,000 to $55,000 Per Day

120days

Average time to First Patient In, industry-wide

25-30%

First submissions that require rework, industry-wide

$37K to $55K/day

Phase III direct costs

Industry averages. Figures vary by phase, therapeutic area, and region.

The bottleneck is not the science. It is activation. Email threads, manual readiness checks, feasibility that cannot predict, and no way to show a regulator why an output is right. Risk-based quality management asks what is critical to quality, what could go wrong, and what you will do when it does. Most trials cannot answer the third question before First Patient In, so preventable findings surface at submission and become rework cycles instead of contingencies. Celina produces a regulatory determination on your protocol: every control obligation enumerated, each one evidenced or open, and a named contingency for the ones still open. There is no activation infrastructure. We are building it.

How It Works

Protocol In. Determination Out.

Determine

Celina reads the protocol and derives the regulatory control obligations that apply to it, in every jurisdiction you are entering. Each obligation carries a versioned citation to the rule it comes from. The output is a determination on the protocol, with the gaps named at section level.

Assess

Each obligation is assessed against risk. What is critical to quality, which controls already exist, which are missing, and what your quality system has to cover before First Patient In. The output is a coverage map, with the standard operating procedure each open item requires.

Generate

For the open items, Celina generates the procedures and documents the protocol and the jurisdiction call for. Work instructions, execution steps, and the records that show the procedure was followed. Written against your protocol and the rule set of your jurisdiction, not drawn from a template library.

Attest

Nothing leaves without a named human signing it. Every determination carries a reconstructable record: which rule, which version, which evidence, which reviewer.

Learn more about Trial Activation Intelligence

The Deliverable

What You Get

A determination

A position on your protocol, per jurisdiction, with every finding traced to a versioned citation of the rule behind it.

A coverage map

Every control obligation marked evidenced, partial, or open, with the procedure each open item requires and a contingency named against it.

A generated procedure set

The documents and work instructions that close the open items, written against your protocol and your jurisdiction, ready for your quality team to review.

We do not publish activation timing or submission outcomes. The sample does not yet support them. When it does, we will publish the sample size alongside the number.