Is TrialStack only for large organizations?

No. Smaller clinical teams can start with one active trial and a focused workflow, such as protocol design, evidence review, or document generation. Larger teams can expand into multi-study governance, stronger controls, and broader operational oversight.

Can we start with one workflow and expand later?

Yes. Most teams should start with one high-value workflow, prove the operating model, then expand. TrialStack is designed so protocol design, evidence synthesis, document authoring, and study intelligence can begin separately while still connecting into the same governed study model.

Do we need to migrate our existing systems?

No full migration is required to start. TrialStack can sit alongside existing documents, source files, trackers, and clinical systems while giving teams a structured workspace for the work that needs governance, traceability, and AI-assisted execution.

How do teams review AI-generated work?

Generated outputs remain reviewable before they are applied. Teams can inspect source context, rationale, comments, changes, and approvals, so AI-assisted work does not bypass human oversight or clinical judgment.

ProductsCatalyst

Connect governed trial workflows to frontier models

Catalyst is the MCP layer between TrialStack and frontier models such as Claude, letting governed workflows request, review, and apply model output without moving context, decisions, or source material outside Studio.

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USE AI WITH CONTROL

Everything teams need to connect governed trial work to frontier models

Catalyst is the MCP layer between TrialStack and frontier models such as Claude, so teams can route governed context to model workflows without creating disconnected prompts, hidden context, or uncontrolled outputs.

Route through MCP

Connect governed trial context, templates, and rules to frontier models such as Claude through a controlled MCP layer.

Keep oversight explicit

Make human review visible before generated work becomes part of the study record.

Work inside Studio

Request, review, and apply model output where clinical teams already manage decisions, evidence, and documents.

Scale adoption consistently

Give teams repeatable AI workflows instead of isolated prompt experiments.

ProductsStudio

One governed workspace for protocol decisions and document authoring

Studio helps clinical teams coordinate protocol design, rationale, review, document authoring, and start-up planning from shared trial records, instead of stitching the same work together across documents, trackers, and disconnected systems.

Model the trial. Shape protocols, evidence, documents, and start-up plans as structured records teams can review, reuse, and govern.

Govern every review. Move drafts, updates, comments, approvals, and changes through traceable decision paths.

Preserve the context. Keep rationale, source evidence, outputs, and audit history connected to the work they support.

ProductsLoop

Request supported trial work without losing customer control

Loop is TrialStack’s service-enabled software workflow. Your team requests supported work, TrialStack performs configured drafting, structuring, and package preparation in Studio, and your organization remains accountable for medical, clinical, regulatory, statistical, and final expert review.

Request the outcome. Send the synopsis, source files, and target deliverables. Loop turns the request into a structured work plan inside Studio.

Track the work. Follow evidence review, drafting, document generation, review, and revisions through one governed workflow

Keep feedback connected. Link comments, changes, approvals, and final artifacts back to the study record that produced them.

Clinical trial package generation workflow

FAQ

Questions clinical teams ask before they trust AI with study work

AI supports drafting, summarization, evidence synthesis, transformation, and review. TrialStack keeps those outputs connected to source context, study records, and human decisions, so generated work stays reviewable before it becomes part of the governed record.

Catalyst

Connect Studio workflows to frontier models with control.

Use Catalyst to route governed TrialStack context through MCP to models such as Claude, then review and apply structured outputs inside the operational record.

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