Trial Design & Study Start-Up

The governed workflow layer for clinical trial teams that need speed, structure, and traceability

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.

Trial design summary preview

Built on trusted standards

Structured around the standards that guide modern clinical development.

Trust

Built for clinical teams that need security answers before they deploy

TrialStack is designed for protocol definitions, study configurations, and document outputs, not patient-level data or PHI.

SOC 2 Type II
SOC 2 Type I
HIPAA
GDPR
ISO 27001

Pricing

Choose the plan that matches your clinical workload

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.

Explore Tiers

Ignite

For small teams launching a first trial who need core governance, evidence, and document controls.

€1,500 / month / Billed annually
  • 1 active trial
  • 3 users
  • 500,000 monthly AI tokens
  • Core study workspace
  • Basic governance controls

Accelerate

For teams managing multiple active studies that need more capacity, stronger governance, and faster support.

€4,500 / month / Billed annually
  • 3 active trials
  • 8 users
  • 2,000,000 monthly tokens
  • 15 active rules
  • Persona engagement feedback included
  • Trial feasibility review included

Scale

For enterprise teams running larger study portfolios with custom limits, identity controls, and dedicated support.

€15,000 / month / Billed annually
  • Unlimited active trials
  • Unlimited users
  • 8,000,000 included monthly AI tokens
  • Identity and access controls
  • Dedicated onboarding and support

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.

Get started

See how governed study work fits into your operating model.

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.