TrialStack is a protocol authoring and study start-up system for clinical trial teams. We help biotechs, clinical trial units and specialized CROs turn trial concepts, evidence and regulatory requirements into structured, reviewable, submission-ready study packages.

The protocol should not be a document. It should be a governed model of decisions, evidence, risks and artefacts. Today, trial decisions get trapped in Word, PDF and email. Teams lose weeks reconciling files instead of reviewing decisions. Rationale, evidence and downstream artefacts drift apart. TrialStack changes the unit of work from document to decision.

We build for teams that need high-quality protocol and start-up artefacts but do not have the internal infrastructure of a large sponsor. Today they rely on consultants, CRO hours, medical writing, regulatory review and manual reconciliation. TrialStack gives them a structured way to do the work they are already doing, with full traceability across the package.
The platform generates evidence packs, protocol sections, rationale, quality checks and the full set of study start-up documents, including ICF, SAP, monitoring plans and country variants. Every output is connected to the underlying decisions and evidence that produced it. Aligned to ICH M11, CDISC USDM and TransCelerate DDF. Built for the governance and traceability bar set by ICH E6(R3).

This is not autonomous AI. It is structured authoring, evidence-backed generation, human review and full auditability.

TrialStack

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TrialStack

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