Clinical Development System
TrialStack is the clinical development system for teams and agents. Its USDM-based canonical model and DDF-aligned study definition repository keep protocol review, document authoring and data acquisition configuration aligned around one governed trial definition.
Built on established clinical standards
TrialStack's canonical model gives teams and agents one governed trial definition that supports structured exports to downstream systems.
TrialStack turns protocol intent into one governed trial definition for teams, systems and agents. Its USDM-based model keeps document authoring and data acquisition configuration aligned through every handoff.
Trust
Review TrialStack's security posture across SOC 2, ISO 27001, ISO 9001, GDPR and HIPAA. Use the Trust Center to inspect controls, policies, subprocessors, FAQs and security documents before vendor approval.
Pricing
Every plan includes TrialStack Studio for governed trial design, evidence and document authoring. Plans differ by active trials, seats, AI usage and concurrent runs.
Ignite
For biotechnology teams and research sites preparing their first active trial. Replace disconnected documents and handoffs with one governed workflow.
Accelerate
For CRO and pharmaceutical teams coordinating up to three active trials. Keep design, evidence and review aligned across parallel work.
Scale
For sponsors, trial units and academic medical centers managing portfolios. Standardize governed trial workflows across departments and up to 20 active trials.
FAQ
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.
Get started
Keep protocol decisions, document authoring and data acquisition aligned around one trial definition. Try TrialStack Studio free for 3 days.
