Navigate the ever-evolving regulatory landscape with a flexible and agile team of trusted experts
Our distinct approach enables us to provide exceptional, tailored support for your medical writing and clinical trial disclosure needs, whether through standalone projects, comprehensive trial assistance, or dedicated FSP resourcing.
Medical Writing and Clinical Trials Disclosure
We are knowledgeable and solutions-oriented subject matter experts with deep domain expertise who focus on every detail to deliver a superior client experience.
Global Medical Writing and Transparency
Medical Writing
ProPharma's medical writers provide strategic, responsive, and flexible medical writing project support. Our team of experts autonomously drive document development, assimilating and summarizing complex scientific data into concise, accurate reports for a wide variety of audiences.
Whether you need project-based support for individual medical writing deliverables or to outsource all medical writing across an entire clinical trial or a complete portfolio of products, our expertise and experience can be leveraged to ensure all your project goals are achieved.
Quality Control Review
Detailed, thorough quality control (QC) reviews are an integral part of the production lifecycle of a document. ProPharma's QC experts review documents across all therapeutic areas to ensure message uniformity, data integrity, and consistency.
Clinical Trials Disclosure Services
ProPharma partners with clients to provide individualized, single-source, scalable solutions within the clinical trials disclosure and transparency landscape.
Thousands of Records Posted, >90% without NIH Comments
Finding experienced resources to register and report your clinical trial, provide document redaction services, or locating the right team for end-to-end management and support of an entire portfolio of studies can be difficult.
Our Clinical Trials Disclosure (CTD) experts are here for you.
Our dedicated team of disclosure experts have successfully registered thousands of studies across multiple registries/therapeutic areas and reviewed thousands of pages for personal and commercially confidential information for redaction.
Let our seasoned project managers and authors navigate you through the ever-evolving clinical trials disclosure landscape.
Medical Writing & Clinical Trials Disclosure Experts
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Pinky Sharma
Director, Medical Writing
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Janice Worley
Global Head, FSP Services
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Meg Weber
Vice President, Medical Writing
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Carrie Yazell
Director, Medical Writing and Quality Control
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Cynthia Fuller
FSP Medical Writing Division Head
Meeting Complex Needs with Strategic Support
ProPharma provides adaptable and targeted assistance designed to align with your specific requirements. Our approach ensures effective outcomes tailored to your scope and scale.
News & Insights
December 15, 2025
Annex 11 2011 Version vs. Annex 11 2025 Draft Version: What are the Differences ...
Discover the key differences and enhancements between Annex 11 2011 and the 2025 draft version for computerised systems in GMP-regulated environments.
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Rescuing a Struggling PV Program: Warning Signs, Root Causes, and What to Do Nex...
Learn how to identify the warning signs of a failing pharmacovigilance vendor and navigate the rescue process to ensure program success.
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Good Machine Learning Practice (GMLP)
Ensuring AI/ML in life sciences meets regulatory standards with ProPharma's GMLP framework, blending innovation with compliance for reliable, safe, and effective digital transformation.
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News & Insights
December 11, 2025
ProPharma Expands Operations with New Office in Hyderabad
ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.
December 4, 2025
ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions
ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
