Clinical Trial Units

Coordinate investigator-led trials around one definition

Clinical scientists, medical writers, data managers and project managers can review the same current trial definition. Investigator intent remains visible through document authoring and start-up.

Clinical Scientists

Shape scientific objectives, endpoints, eligibility and operationally feasible design parameters.

Medical Writers

Build review-ready protocol content from approved design elements and evidence.

Clinical Data Managers

Review the SoA, data collection requirements and the handoff into acquisition systems.

Clinical Project Managers

Coordinate readiness, responsibilities and downstream follow-up across the unit.

Use casesScientific design

Turn scientific intent into a governed trial definition

Clinical scientists and trial designers structure objectives, endpoints, eligibility, interventions and the SoA in one current definition. Reviewers can trace rationale and changes before downstream work begins.

Structure the design. Capture objectives, endpoints, eligibility, interventions and activities as connected trial elements.

Reuse prior decisions. Bring forward approved patterns without losing the evidence and rationale behind them.

Review before handoff. Resolve ambiguity while the scientific and operational owners can still change the design.

                    flowchart TD
  A["Scientific intent"] --> B["Structured trial design"]
  B --> C["Cross-functional review"]
  C --> D["Approved 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 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.

Contract Research Organizations

Give sponsor-facing delivery teams one governed trial definition for protocol authoring, data acquisition preparation and start-up.

Biotechnology Companies

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

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