Managing clinical trial submissions and disclosure requirements is challenging with conflicting application needs and document burden. With many moving parts, including tracking multiple trials, changing regulations, and submission deadlines, our services can help you:

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Streamline high-quality submissions

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Ensure regulatory compliance

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Be inspection-ready

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Increase patient engagement

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Safeguard your brand reputation

From protocol registration, results disclosure, and redactions we offer a range of hands-on services to help companies small and large manage their clinical trial transparency and disclosure processes in line with local and global requirements and regulations.

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How it helps

If your team is stretched thin or you want to simply improve policies and processes, we can act as an extension of your team to provide the expertise and help you to maximize compliance and minimize risks.

Leverage our qualified team of regulatory and disclosure experts, each with over seven years of experience, to support your specific disclosure challenges and needs, helping you to reduce risks of noncompliance, avoid sanctions and fines, and any reputational damage to your business.

Our services include:

Whether you're a large, mid-size or small pharmaceutical company, your organization can benefit from outsourcing regulatory and disclosure-related tasks to:

Protocol Registration

Results Disclosure

Plain Language Summaries

Redaction

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How it works

You don't have to manage disclosure compliance alone. Outsource your disclosure tasks to reduce submission cycle times and increase efficiency. Select the services you need and scale them to fit your organization priorities, and changing regulatory needs:

  • Protocol Registration
  • Plain Language Summaries (Results and Protocol)
  • CTIS/EudraCT-specific tasks
  • Results Disclosure
  • Redaction
  • Advisory Services / Workshops
Disclosure expert consulting with a client.
Disclosure expert working at her desk reviewing documents. Disclosure expert working at his desk.
Our experts
Discover how our services can help you gain a competitive edge. Citeline’s regulatory intelligence, solutions, and services ensure your organization improve and maintain disclosure compliance, guided by the industry’s leading experts on clinical trial disclosure and transparency.
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Contact us today to learn how we can support your clinical trial disclosure needs.
Request a demo with a Citeline expert to see how our services make the clinical trial disclosure process easier.
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