Navigate the ever-evolving regulatory landscape with a flexible and agile team of trusted experts
Our unique Research Consulting Organization (RCO) model allows us to deliver unparalleled, customized service focused on meeting your specific medical writing and clinical trials disclosure needs, whether through standalone project work, full-service trial support, 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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Marcy Komocsar
Senior Vice President, Clinicial Research Solutions
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Janice Worley
Vice President, Medical Writing
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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
Senior Director, Medical Writing
Complex Needs Require Custom Solutions
ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.
News & Insights
October 7, 2024
PMA Post-Approval Study Considerations
Learn the essential considerations for conducting Post-Approval Studies (PAS) for medical devices, including protocols, timelines, and reporting requirements to ensure compliance with FDA regulations.
September 30, 2024
What is a Clinical Evaluation Report (CER)?
Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.
September 26, 2024
Navigating Uncertainty with the FDA LDT Rule
Explore the FDA's 2024 Final Rule on Laboratory Developed Tests (LDTs), outlining a four-year phaseout of enforcement discretion, its impact on labs, and compliance strategies.
News & Insights
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
June 13, 2024
ProPharma Receives 2024 CRO Leadership Award
ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.
