Contract Research Organizations

Keep sponsor intent intact across delivery teams

Use one governed trial definition to carry sponsor-approved decisions into protocol authoring, data acquisition preparation and start-up. Version history and review context stay attached through each handoff.

Clinical Project Managers

Coordinate sponsor requirements, cross-functional delivery and start-up decisions across the trial lifecycle.

Medical Writers

Draft and revise protocol content while keeping approved trial decisions and source evidence visible.

Clinical Data Managers

Review the SoA, data requirements, eCRF design and downstream acquisition handoff.

IT Software Architects

Evaluate APIs, mappings, access controls and the systems that consume the trial definition.

Use casesProtocol authoring

Draft protocol content from approved trial decisions

Medical writers generate prose from governed design elements and linked evidence. Drafts, comments and amendments remain connected to the trial definition behind them.

Generate from the definition. Use current trial elements and evidence instead of reconstructing intent from disconnected files.

Control the review. Keep comments, decisions and approvals tied to the content under review.

Manage amendments. Compare approved versions and carry changes into the affected protocol content.

                    flowchart TD
  A["Approved design elements"] --> B["Protocol draft"]
  B --> C["Structured review"]
  C --> D["Controlled revision"]

Use casesData acquisition

Prepare data acquisition from the digital protocol

Clinical data managers review the SoA, biomedical concepts and data requirements before eCRF and EDC configuration. Target-specific automation still depends on mappings, integration, validation and human approval.

Review data requirements early. Connect activities, assessments and data elements before the build is locked.

Prepare the handoff. Package governed inputs, mappings and target findings for downstream configuration.

Keep approval explicit. Retain UAT, validation and data-management accountability at the receiving boundary.

                    flowchart TD
  A["Digital protocol and SoA"] --> B["Data requirements"]
  B --> C["Acquisition package"]
  C --> D["EDC or eCRF build review"]

Use casesTrial start-up

Carry approved design into trial start-up

Clinical operations teams use the current trial definition to prepare sites, vendors, contracts and operational systems. Changes remain visible to the owners responsible for execution.

Prepare downstream teams. Give sites and vendors a consistent view of the approved design and its operational implications.

Keep requirements connected. Link start-up documents, responsibilities and clarifications to the trial decisions they implement.

Surface change impact. Show affected work when an approved definition changes before execution.

                    flowchart TD
  A["Approved trial definition"] --> B["Start-up requirements"]
  B --> C["Site and vendor review"]
  C --> D["Execution readiness"]

Built on established clinical standards

TrialStack's canonical model gives teams and agents one governed trial definition that supports structured exports to downstream systems.

Customers

Compare clinical operating models

See how sponsors, CROs, trial units and research sites use the same governed trial definition for different workflows.

Biotechnology Companies

Give a lean development team one governed trial definition for scientific design, protocol authoring and data acquisition preparation.

Clinical Trial Units

Connect investigator intent, protocol authoring and operational preparation across scientific and delivery teams.

Pharmaceutical Companies

Govern one reusable trial definition across clinical development, data management, operations and R&D IT.

Academic Medical Centers

Connect investigator-led design, protocol authoring and trial start-up across academic departments.

Research Sites

Carry sponsor intent into site start-up, data acquisition and amendment review without losing context.

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.

Ignite

For biotechnology teams and research sites preparing their first active trial. Replace disconnected documents and handoffs with one governed workflow.

$750/ month

Free Trial

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

Free Trial

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

Free Trial

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.

Free Trial Explore Studio