Ignite
For small teams launching a first trial who need core governance, evidence, and document controls.
- 1 active trial
- 3 users
- 500,000 monthly AI tokens
- Core study workspace
- Basic governance controls
Trial Design & Study Start-Up
TrialStack helps clinical teams move from protocol design to submission-ready study packages through structured evidence review, document generation, and auditable start-up decisions aligned with ICH M11 and USDM.
Built on trusted standards
Structured around the standards that guide modern clinical development.
TrialStack connects protocol design, evidence synthesis, medical writing, and study intelligence in one governed environment, so teams can reuse decisions, preserve rationale, and keep every document aligned.
Trust
TrialStack is designed for protocol definitions, study configurations, and document outputs, not patient-level data or PHI.
Pricing
Start with one active trial, then scale into multiple studies, larger teams, higher AI usage, stronger governance controls, and priority support as your study-startup work grows.
Ignite
For small teams launching a first trial who need core governance, evidence, and document controls.
Accelerate
For teams managing multiple active studies that need more capacity, stronger governance, and faster support.
Scale
For enterprise teams running larger study portfolios with custom limits, identity controls, and dedicated support.
FAQ
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.
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.
Yes. Most teams should start with one high-value workflow, prove the operating model, then expand. TrialStack is designed so protocol design, evidence synthesis, medical writing, and study intelligence can begin separately while still connecting into the same governed study model.
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.
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.
Get started
Talk through your trial design, evidence review, document generation, and start-up workflows, then choose the Studio, Loop, or Catalyst path that fits your team.