global medical writing & transparency

Your strategic partner for the preparation of regulatory documents.

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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.

 

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.

Explore Medical Writing Services

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.

Explore QC Review/Editing

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. 

Explore Clinical Trial Disclosure Services


Medical Writing & Clinical Trials Disclosure Experts

Mary Culliton Headshot

Mary Culliton

Senior Vice President, Medical Writing

Janice Worley Headshot

Janice Worley

Vice President, Medical Writing

Meg Weber Headshot

Meg Weber

Vice President, Medical Writing

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Michael Church

Vice President, Medical Writing

Pinky Sharma Headshot

Pinky Sharma

Director, Medical Writing

Carrie Yazell Headshot

Carrie Yazell

Director, Medical Writing and Quality Control

Cynthia Fuller Headshot and bio photo

Cynthia Fuller

Senior Director, Medical Writing

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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

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Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

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Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...

Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

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Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

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News & Insights

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Press Releases ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry

January 4, 2024

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Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

Previous Award Arrow Next Award Arrow
Quality & Compliance GxP Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

February 29, 2024

Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...

General Regulatory FDA Meetings Regulatory Sciences Formal FDA Meetings for Sponsors or Applications of PDUFA Products

February 26, 2024

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

FDA Regulatory Sciences The Impact of a US Government Shutdown on the Food and Drug Administration

February 26, 2024

The Impact of a US Government Shutdown on the Food and Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow