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.
Elevate transparency with strategic & hands-on services
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.
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
Protocol Registration
Protocol Registration
Authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data, resolving CTgov comments and maintaining registrations
Plain Language Summaries (PLS)
Plain Language Summaries (PLS)
Consulting, development, and launch of PLS program, plus PLS authoring, including QC and graphic design
CTIS/EudraCT-specific tasks
CTIS/EudraCT-specific tasks
Preparation and delivery of Clinical Trial Application (CTA) and Third Country Registration
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
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.
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.
Citeline Regulatory & Compliance solutions
TrialScope Disclose
The most widely trusted solution for clinical trial disclosure management
TrialScope Intelligence
A centralized, interactive repository of the critical regulatory knowledge needed for global clinical trial disclosure compliance
Trial Summaries
This user-friendly portal aggregates clinical trial results summaries across sponsors
Request more information
A specialist is ready to speak to you regarding your interests and find the solutions that are right for you.
