Navigate regulatory complexity with confidence.

Stay ahead of evolving global regulations, fulfill disclosure obligations across jurisdictions, and reduce the risks associated with noncompliance throughout the clinical development lifecycle.

End-to-End Regulatory & Disclosure Solutions

Connect intelligence, technology, and expertise.

Monitor changes, understand obligations, and manage disclosure activities through a comprehensive portfolio designed to support the entire disclosure lifecycle.
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Stay ahead of regulatory change

Access trusted intelligence to identify, interpret, and monitor evolving global requirements.

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Manage disclosure with confidence

Centralize registrations, results disclosures, and related obligations.

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Extend your team with experts

Add flexible disclosure, regulatory, and medical writing support.

Why it matters

Disclosure requirements are increasingly complex

Missing a disclosure requirement can bring penalties and reputational harm, and the rules keep changing globally
~30%
of US trials required to report results have none posted
$15K+
in FDA penalties per day for uncorrected disclosure violations
<50%
of EU trial results reported on time
130+
new disclosure documents published each year, across 195+ countries
Sources: FDA (2026), 45 CFR 102.3, medRxiv EU CTIS analysis (2026), Citeline TrialScope Intelligence.
Regulatory & Disclosure in Practice

What you can do with Citeline

Monitor and interpret global requirements

Stay informed as regulations and disclosure obligations evolve across countries and registries.

  • Access continuously maintained global disclosure requirements
  • Quickly identify and interpret relevant obligations
  • Support informed compliance planning and decision-making
A woman reviews text on two large monitors and a laptop in a bright office, focused on a multi-screen digital document workflow.

Manage disclosure activities end to end

Bring trial registration, results disclosure, and registry activities into a more consistent and controlled process.

  • Streamline trial registration and results disclosure
  • Manage obligations across multiple registries
  • Support efficient, accurate, and audit-ready compliance processes
A hand selects a checked digital form on a glowing laptop, amid floating checklist icons—suggesting online review, task completion, and efficient technology.

Increase transparency and stakeholder access

Make clinical trial results easier for patients, participants, and other stakeholders to understand and access.

  • Publish and share plain language summaries
  • Support transparency across studies and sponsors
  • Improve participant and stakeholder engagement
A businessperson in a dark suit presses a glowing “TRANSPARENCY” button amid blue data and analytics icons, creating a sleek, professional tone.

Scale with specialist support

Extend internal teams with experienced disclosure specialists and medical writers.

  • Support trial registration, results disclosure, and registry submissions
  • Develop plain language summaries and regulatory documentation
  • Add flexible expertise for ongoing compliance and submission activities
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Products & Data

Explore the products behind the workflow

Explore Citeline’s regulatory & disclosure intelligence in one connected workflow.
How it compares

From fragmented activity to connected regulatory and disclosure support

Connect the information, workflows and expertise to manage disclosure with confidence
A Fragmented Approach The Citeline Approach
Regulatory changes monitored across separate sources Trusted regulatory intelligence supports a more centralized view of evolving requirements
Disclosure obligations managed across disconnected processes Technology supports registration, results disclosure, and multi-registry obligations
Transparency activities handled as isolated deliverables Plain language summaries and result sharing support wider stakeholder access
Internal teams absorb fluctuating specialist workload Flexible disclosure and writing services extend internal resources
Compliance information and execution remain separated Intelligence, technology, and expert services work together across the lifecycle
Related Regulatory Intelligence

Go deeper on regulatory policy and industry change

Article

FDA Issues a Transparency Roadmap: What Changes for Clinical Trial Disclosure, and What Does Not

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Webinar

Global Clinical Trial Disclosure: Are You Casting a Line or a Net?

Futuristic digital human anatomy model surrounded by glowing data streams, binary code, and blue-pink holographic graphics.
Report

The Trials of Trial Discovery: How Physicians Find, Evaluate, and Share Clinical Trial Information

FAQ

Frequently Asked Questions

They are designed for sponsors that need to monitor regulatory change, understand global disclosure requirements, manage trial registration and results disclosure, publish plain language summaries, or extend internal resources with specialist support.
The portfolio includes regulatory and disclosure intelligence, clinical trial disclosure management technology, plain language summary publishing, disclosure services, and regulatory and medical writing services.
Citeline combines continuously maintained requirements, technology for managing registration and results disclosure activities, and expert support to help teams make informed decisions and execute compliance activities more consistently.
Yes. TrialScope Disclosure Services provides flexible support for registration, results disclosure, registry submissions, plain language summaries, and ongoing compliance activities. Regulatory & Medical Writing Services provides additional writing and submission support.
Citeline supports transparency through disclosure management, access to global requirements, and tools for publishing and sharing plain language summaries with patients, participants, and stakeholders.
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Tell us your compliance priorities and we’ll show you how Citeline helps you stay ahead of changing disclosure requirements

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