Structure protocol decisions
Define endpoints, eligibility and objectives as connected trial decisions alongside the SoA and operational controls.
ProductsStudio
Carry protocol decisions into review-ready documents
Studio gives clinical teams one governed workspace for trial design, evidence and document authoring. Plans start at $750 per month and include a 3-day free trial.
STRUCTURE TRIAL WORK
Carry approved trial decisions from design through start-up
Model protocol decisions, evidence and document authoring in one governed workspace. Approved changes stay connected to the trial definition that downstream work uses.
Keep rationale visible
Attach the evidence, assumptions, trade-offs, and clinical reasoning behind each design choice.
Align teams earlier
Give clinical, regulatory, statistical and writing teams the same current view of what is being designed and why.
Carry decisions forward
Reuse approved design decisions across Evidence Packs, protocol sections and downstream trial start-up work.
FAQ
How TrialStack puts digital protocol standards to work
Digital Data Flow replaces repeated document interpretation and manual re-entry with a machine-readable trial definition. TrialStack uses that definition to keep protocol review, document authoring and data acquisition configuration aligned.
TrialStack uses USDM as the standards-based structure for the governed trial definition, including design, objectives, endpoints, eligibility, interventions and the schedule of activities. The model remains versioned, reviewable and available for structured exchange instead of being trapped in protocol prose.
TrialStack includes a DDF-aligned Study Definition Repository around its canonical model. It retains versioned trial definitions with their decisions, lineage, review and export evidence so teams, systems and agents work from the same governed source.
TrialStack sits upstream of execution systems and does not require replacing them. Teams can create governed USDM, ODM, Viedoc, REDCap, SDTM Trial Design and ICH M11 outputs while retaining findings wherever a target cannot preserve the full trial definition.
TrialStack versions the trial definition and keeps amendments, decisions, source evidence and downstream artifacts linked to the source state that produced them. Teams can review the impact and create a new governed export without rewriting the historical record.
Pricing
Choose capacity for the trials you run
Every plan includes TrialStack Studio for governed trial design, evidence and document authoring. Plans differ by active trials, seats, AI usage and concurrent runs.
Monthly prices shown
Ignite
For biotechnology teams and research sites preparing their first active trial. Replace disconnected documents and handoffs with one governed workflow.
$750/ month
- 1 active trial
- 3 seats included; add more at $100 / month
- 500,000 monthly AI tokens
- 2 concurrent AI workflows
Accelerate
For CRO and pharmaceutical teams coordinating up to three active trials. Keep design, evidence and review aligned across parallel work.
$3,000/ month
- 3 active trials
- 8 seats included; add more at $100 / month
- 2,000,000 monthly AI tokens
- 5 concurrent AI workflows
Scale
For sponsors, trial units and academic medical centers managing portfolios. Standardize governed trial workflows across departments and up to 20 active trials.
$3,750/ month
- 20 active trials
- 15 seats included; add more at $100 / month
- 8,000,000 monthly AI tokens
- 10 concurrent AI workflows
Get started
Give your next clinical trial a governed foundation
Keep protocol decisions, document authoring and data acquisition aligned around one trial definition. Try TrialStack Studio free for 3 days.