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Kyros Trials: the facts.

Last updated . Also available as llms.txt, llms-full.txt and pricing.json.

What it is

Kyros Trials is all-in-one web software for independent clinical research sites and small site networks. It covers site CTMS, eSource and eCRF, an eRegulatory binder, eConsent, recruiting with AI prescreen, visit scheduling, monitoring and SDV, and sponsor financials.

Who it is for

  • Independent clinical research sites running sponsor-funded studies
  • Small site networks with 2 or more locations
  • Site directors, research coordinators, investigators and site finance teams

Who it is not for

  • Sponsors or CROs looking for a sponsor-side CTMS or EDC
  • Private medical practices looking for patient intake or patient billing
  • Manufacturing or laboratory quality systems

Modules

  • Site CTMS: Studies, participants, visit schedules with windows and a site-wide calendar.
  • eSource and eCRF: Source captured at the visit, edit checks, monitor queries on the field, SDV status and record locking.
  • eRegulatory binder: Versioned essential documents, delegation log, training records and expiry alerts.
  • eConsent: Consent versions, re-consent tracking after amendments and electronic signatures.
  • Recruiting and AI prescreen: Public prescreen per study, an AI chat that asks eligibility questions, and a candidate pipeline.
  • Monitoring: Study-scoped outside-monitor access, monitor visits and remote SDV.
  • Sponsor billing: Per-visit and per-procedure fee schedules, procedures-not-done reasons, earned unbilled items and sponsor invoices with draft, sent, paid and overdue status.
  • Safety: Adverse events with CTCAE grading, deviations with CAPA, and expedited report drafting.
  • Exports: Export to CDISC ODM 1.3.2 and SDTM-aligned CSV, plus CSV and PDF, at any time.
  • Kyros Trials Assistant: An AI assistant that answers questions from the data your role can see and drafts text for your review.

Core module capabilities

Available with Advanced off. Role and study access still apply; optional AI requires the appropriate plan and configured service.

Clinical trial management software for independent research sites.

  • Study records: Keep the study identifier, sponsor and operating context together.
  • Schedule of assessments: Define visits and procedures against the study’s protocol schedule.
  • Day 1 anchors: Record the participant’s anchor date for scheduled visit targets.
  • Early and late windows: Show target dates with the permitted opening and closing dates.
  • Participant schedules: Inspect planned visits within one participant’s study record.
  • Site-wide Schedule: See appointments across the site without a separate calendar ledger.
  • Today worklist: Review due visits, outstanding review and unbilled work together.
  • Out-of-window flags: Preserve the actual visit and follow up on the window issue.
  • Study progress: Separate randomized progress from screen-fail reporting.
  • Tasks and access: Assign follow-up work while keeping study access role-scoped.

eSource and eCRF for independent research sites.

  • Visit-linked forms: Open electronic forms in the study and visit context.
  • Procedure fields: Capture the values required for the configured procedure.
  • Required-field checks: Prompt staff for required information before submission.
  • Edit checks: Review configured range and format issues during capture.
  • Field-level queries: Keep a reviewer’s question tied to the source field.
  • Query responses: Retain staff answers within the review workflow.
  • Verification status: Distinguish entered source from completed review.
  • Investigator signatures: Require the authorized signer to re-authenticate.
  • Reasoned corrections: Retain before/after values and the stated change reason.
  • Data exports: Review CDISC ODM 1.3.2 and SDTM-aligned CSV exports.

eRegulatory binder for independent research sites.

  • Study binders: Organize essential documents against the study they support.
  • Document classification: Classify document types in the study’s essential-record register.
  • Version metadata: Record revision identifiers and document version information.
  • IRB records: File approvals and amendments in study context.
  • Validity dates: Record effective and expiry information for review.
  • Expiry worklist: Bring upcoming regulatory expirations into the site’s work.
  • Delegation log: Record staff responsibilities within the study.
  • Training records: Keep staff training information available for review.
  • Electronic signatures: Use the shared authorized signing workflow.
  • Scoped monitor access: Define the study and period an outside reviewer can access.

eConsent for clinical trials at independent research sites.

  • Study consent documents: Associate informed-consent documents with the study.
  • Version identifiers: Keep the specific consent version identifiable.
  • Approval information: Retain the approval context for staff to review.
  • Participant assignments: Connect required consent work to participant records.
  • Signed-version status: See the version recorded for a participant.
  • Re-consent visibility: Review pending assignments after a version change.
  • Completion records: Record re-consent completion through the staff workflow.
  • Consent history: Review participant assignments and recorded completion history.
  • Staff follow-up: Use participant consent status to plan the next conversation.
  • Re-consent gate: Study-linked source inserts check pending required re-consent assignments.

Clinical trial recruiting with staff-led screening.

  • Candidate records: Keep interested participants in the recruiting workflow.
  • Study context: Associate recruiting activity with the relevant study.
  • Screening criteria: Maintain study criteria for staff-led review.
  • Shareable prescreen: Provide a study prescreen entry point for candidates.
  • Consent before health questions: Request permission before the automated health-question flow.
  • Automated-assistant disclosure: Identify automated interaction when that option is configured.
  • Human contact option: Keep a route to the study team available.
  • Staff review queue: Review responses before deciding the next screening step.
  • Screen-fail reasons: Record why screening did not lead to enrollment.
  • Separate progress reporting: Distinguish candidate activity from randomized progress.

Sponsor invoicing for clinical research sites.

  • Study/site fee schedule: Maintain negotiated per-visit and per-procedure amounts in the study context. Procedure fees apply at every scheduled visit or one selected visit.
  • Procedure completion checklist: Review scheduled procedures at visit entry. Mark procedures not done with a short reason; those procedure fees do not accrue.
  • Entered triggers: Accrue a configured item when source entry meets its trigger.
  • Verified triggers: Use review completion where the negotiated trigger requires it.
  • Unbilled review: Inspect pending earned work before invoicing.
  • Study grouping: Group unbilled items by study for reconciliation.
  • Participant-code context: Follow an item to the participant’s completed work.
  • Linked invoice items: Create an invoice from selected eligible unbilled items.
  • Printable invoice detail: Review sponsor, site, study and item totals before sending, with visit and procedure lines grouped under each visit.
  • Status and reasoned void: Track invoice status and preserve corrections through voiding.

Prices and terms

  • Starter: $299 per location per month ($2,990 per year if paid annually). 1 location, Up to 8 active studies, Core site workflows, Unlimited users.
  • Site: $599 per location per month ($5,990 per year if paid annually). 1 location, Unlimited studies, Core site workflows, plus AI drafting, prescreen and assistant, Unlimited users.
  • Network: $499 per location per month ($4,990 per year if paid annually). 2+ locations, Everything in Site, One company across all locations, Per-location billing, Shared fee schedules.
  • Founding-site offer: Site plan at $399 per month, locked for 12 months. First 10 sites, in exchange for a case study. 10 of 10 spots available.
  • Onboarding fee: $0. Data migration: free.
  • Contract: month-to-month. Cancel any time. Export all your data at any time as CSV or PDF, or export to CDISC ODM 1.3.2 and SDTM-aligned CSV.
  • Prices in US dollars. Full details on the pricing page.

Compliance posture

  • Supports 21 CFR Part 11 controls: a time-stamped audit trail of every change, with user, before/after values and reason; e-signatures with password re-authentication; and role-based access.
  • No software is "Part 11 compliant" on its own. Compliance depends on how each site validates and uses the system. Validation documentation for the system is in progress and available to customers under NDA.
  • Data is encrypted in transit and at rest.
  • AI drafts the routine documents. Your team approves them. AI never decides eligibility, never signs and never sends anything on its own. Every AI request and output is logged with the model version and the approving user.
  • We never sell your data. Your data is never used to train AI models, ours or anyone else's.
  • Kyros Trials will sign a BAA once our HIPAA-eligible hosting and AI infrastructure are fully in place. Contact us for the current status.

Company

  • Product: Kyros Trials
  • Legal entity: Bordano Tissue, LLC, doing business as Kyros Trials
  • Website: https://kyrostrials.com
  • Contact: book a demo or send a question

What we do not claim

  • We do not publish customer counts, ratings or testimonials yet.
  • No software is "Part 11 compliant" on its own. Compliance depends on how each site validates and uses the system.
  • We do not hold FDA clearance or third-party security certifications, and we do not claim them.