Basic Info

Clinials is a Protocol Intelligence Platform that generates the complete clinical trial startup document suite from a single protocol upload. Built for sponsors, CROs, site networks, central labs, and logistics suppliers, Clinials compresses weeks of manual document preparation into minutes.

From one protocol upload, Clinials generates: Schedule of Activities, Informed Consent Forms, Source case report forms, plain language summaries, patient recruitment materials, operational protocol synopsis, investigator summaries, lab listings, CIR's and Protocol to Marketing reports.

Clinials operates on AWS infrastructure with SOC 2, ISO 27001, and AES-256 encryption. Outputs are aligned with EU CTR 536, ICH E6(R3), ICH E17, and FDA 2025 plain language guidance.

Clinials serves sponsors, CROs, site networks, SMOs, IROs, central labs, and clinical trial logistics suppliers across North America, Europe, Asia Pacific, and the United Kingdom. No integration with existing eClinical systems is required.

Why work with us

Clinials compresses weeks of manual clinical trial document preparation into minutes, generating the complete startup document suite from a single protocol upload across every version, draft, amended, and final, with no integration required.

For sponsors, CROs, sites, central labs, and logistics providers, that means faster activation, fewer version reconciliation delays, and measurable time and cost savings from the first session.

Brochure

Video

Company focus

Services

Focus
Services
Innovation Specialisation

Industries

Biotechnology
Computer Software
Pharmaceuticals
Research

Projects or Case studies (3)

PDFSponsor Information Kit - Case Study

Sponsor Information Kit - Case Study

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Document delays in clinical trials happen at four distinct phases: feasibility, specification, startup, and amendment. Your teams are managing all four manually, on every study, across the full programme lifecycle. Clinials removes all four from a single protocol upload. This kit provides your clinical operations leadership, medical writers, regulatory affairs, financial decision makers, and project management teams with a clear understanding of how Clinials works across all four phases of protocol document generation, what it delivers across your study portfolio, and why leading sponsors are integrating it into their clinical development operations.

PDFCase Study Labs, save 2.5 hours per protocol extraction

Case Study Labs, save 2.5 hours per protocol extraction

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If the central lab is processing 20 or more protocols per week, a significant portion of your proposals and operations team's time is being spent on manual protocol extraction before any commercial or clinical value is added. Based on a 3 hour manual baseline per protocol, which reflects the feasibility and proposal work most lab teams tell us they are carrying, a lab at 30 protocols per week is absorbing approximately 75 hours of specialist staff time every week on extraction and document production alone.

PDFCase Study Oncology Phase III trial

Case Study Oncology Phase III trial

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The cost of manual document generation is not a one-time startup event. It recurs at every protocol amendment: and oncology Phase III trials average 3.5 amendments each. This model quantifies that compounding cost and the value Clinials returns across the full programme lifecycle.

Contacts

Maree Beare Avatar

Maree Beare

Australian Clinical Trial California Roadshow Directory