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

Pinky Sharma Headshot

Pinky Sharma

Director, Medical Writing

Marcy Komocsar headshot

Marcy Komocsar

Global Head, Medical Writing and Medical Services

Janice Worley Headshot

Janice Worley

Vice President, Medical Writing

Mary Culliton Headshot

Mary Culliton

Senior Vice President, Medical Writing

Meg Weber Headshot

Meg Weber

Vice President, Medical Writing

michael-church

Michael Church

Vice President, 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.

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ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

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

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

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

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

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

The Inc. 5000 list recognizes ProPharma as one of the fastest-growing companies in America, achieving the highest ranking in ProPharma's 20+ year history.

Previous Award Arrow Next Award Arrow
How to Decentralize Cell and Gene Therapy Treatments

May 20, 2024

How to Decentralize Cell and Gene Therapy Treatments

Decentralization of cell and gene therapeutics improve patient outcomes by reducing time to treatment, increase viability and reduce overall costs.

Meet the Expert: Kirsty Bryant

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Meet the Expert: Kirsty Bryant

Meet Kirsty Bryant! She is a MI Program Manager at ProPharma within the Medical Information team.

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May 14, 2024

What to Expect During the NDA Review Process

Discover what to expect during the NDA review process, from acceptance for filing to information requests and label negotiation.

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...

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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