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Elevate transparency with strategic & hands-on services

Leverage a team of regulatory writing and clinical trial transparency experts, with a minimum of seven years' experience. Our medical writing and disclosure services include regulatory writing, protocol registration, results disclosure, plain language summaries and redaction. If your team is stretched too thin or you want to improve policies and processes, our team is ready to assist you in maximizing your regulatory and disclosure compliance and minimizing your risk.

How it helps

As a sponsor, you will know how difficult it is to manage your clinical trial submissions and disclosure requirements. There are so many moving parts before, during, and after each study, including tracking: multiple trials, ever-changing regulations, submission deadlines, and much more.

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

Streamline high-quality submissions

Ensure regulatory compliance

Be inspection-ready

Increase patient engagement

Defend brand reputation

How it works

You don't have to do it alone. Reduce cycle times and increase process efficiency by outsourcing your disclosure tasks and planning.

Select just the services you need and scale them accordingly, so you can adjust to accommodate your changing organizational priorities and regulatory needs.

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Regulatory Writing

Regulatory Writing

Our expert Medical Writers ensure high levels of quality, consistency, and strategic guidance, while integrating seamlessly into your in-house team when authoring documents for regulatory submissions

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Protocol Registration

Protocol Registration

Authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data, resolving CTgov comments and maintaining registrations

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Plain Language Summaries (PLS)

Plain Language Summaries (PLS)

Consulting, development, and launch of PLS program, plus PLS authoring, including QC and graphic design

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CTIS/EudraCT-specific tasks

CTIS/EudraCT-specific tasks

Preparation and delivery of Clinical Trial Application (CTA) and Third Country Registration

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Results Disclosure

Results Disclosure

Preparing documents including final study protocol, final statistical analysis plan (SAP) and amendments, disclosing on CTgov and preparing XML upload for EU trials

We are ready to assist in maximizing compliance and minimizing risk

Related resources

Infographic preview of The 9 Hidden Costs of Clinical Trial Disclosure.
OCT 06, 2023
Infographic
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9 Hidden Costs of Trial Disclosure

From system implementation to protocol registration and process assessment, hidden costs lurk at every step of the clinical trial disclosure process.

Trial Diversity from a Disclosure Perspective
JUN 03, 2024
Article
Regulatory & Compliance

Trial Diversity from a Disclosure Perspective

At Citeline’s TrialScope EXTRA event, this session focused on clinical trial diversity from FDA action plans and the perspective of disclosure compliance.

Trial Summaries-Improving Patient-Centric Communications resource-card-thumbnail
JUL 01, 2023
White paper
Regulatory & Compliance

Trial Summaries Improving Patient-Centric Communications

The Pharma R&D Annual Review 2023 Supplement looks at new active substances (NASs), drugs launched onto the market for the first time, during 2022

A person wearing glasses and a white shirt.
A person standing in front of a glass wall with sticky notes. A person shaking hands with another.
Our experts
The clinical trial disclosure team at Citeline’s TrialScope Disclosure Services helps organizations from large pharmaceutical corporations to specialty biotechs maintain regulatory compliance.

Our industry experts have been involved in Disclosure since 2005, actively involved in industry groups and conferences.

We have experience in the market leading TrialScope Disclose software as well as working directly in registries.
Request more information
A specialist is ready to speak to you regarding your interests and find the solutions that are right for you.
Request a demo with a Citeline expert to see how our services make the clinical trial disclosure process easier.
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