medical writing services

An industry leader in providing global, strategic, responsive, and flexible medical writing project support.

Woman writing in notebook

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.

Medical Writing Services

 

ProPharma provides comprehensive medical writing and document management services for all clinical and safety documentation required throughout the drug development lifecycle as well as other scientific communications.

Core strengths include the experience of our team and the ability of our talented medical writers to distill and assimilate scientific data to produce clear, concise, credible, and complete deliverables.

Hands typing on keyboard

ProPharma medical writers:

  • Autonomously drive the document development process
  • Make early contact with the team, identify key stakeholders, and establish clear expectations
  • Work with the team to develop timelines, determine project drivers, and assess all potential risks early in the process
  • Lead document development, develop and refine key messages, and coordinate and manage input from cross-functional stakeholders
  • Manage client review cycles, comment adjudication, and quality review
  • Facilitate signoff, publishing, and distribution of final, approved documents

Benefits of Working with Our Medical Writing & Editing Team

global-submissions

GLOBAL AND EXPERIENCED

Our medical writers are located across North America, UK, EU, Australia, China, Japan, and India. Our writers have an average of 8 years of writing experience, many have advanced degrees, and the depth of experience encompasses multiple therapy areas.

regulatory-sciences

SCALABLE

With access to a large pool of experienced medical writing resources, we can scale up as needed to accommodate any demand.

Submissions

QUALITY FOCUSED

We believe quality is intentional. Using a documented and systematic approach, we build quality into each document as it evolves through its lifecycle.

full-service-clinical-trials

ADEPT PROJECT AND STAKEHOLDER MANAGEMENT

With experience managing deliverables from start to finish, we autonomously coordinate all aspects of input, production, and review of every document while skillfully collaborating with global, cross-functional teams.

Our Medical Writing Portfolio

Our medical writing portfolio encompasses execution of hundreds of deliverables spanning all types of clinical, safety, and other scientific communication documents, including but not limited to:

Clinical

  • Clinical Study Reports (CSRs)
  • Protocols and Protocol Amendments
  • Investigator’s Brochures (IBs) and IB Updates
  • Regulatory Submission Summary Documents (IND/NDA/MAA/CTA)
  • Responses to Questions (RTQs)/Regulatory Responses (across multiple health authorities)
  • Pre-Meeting Packages/Briefing Packages
  • Orphan Drug Applications
  • Pediatric Investigation Plans
  • Pediatric Study Plans (including waivers)
  • Health Outcomes Economics/Real World Evidence Documents
  • Fast Track Designation
  • Orphan Drug Designation (ODD) Application/Annual Reports
  • Immunogenicity Reports
  • Ethnic Sensitivity Reports
  • Conditional Marketing Authorization (CMA)
Healthcare workers sitting at table working on tablet devices
Group of professionals collaborating at board

Safety

  • Development Safety Update Reports (DSURs)
  • Periodic Benefit Risk and Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Risk Management Plans
  • Assessment of Benefit Risk (ABR)
  • Annual Reports
  • Patient Safety Narratives

Nonclinical

  • Pharmacology, Pharmacokinetic, and Toxicology Reports (in vivo/in vitro)
  • Bioanalytical Reports

Diagnostics

  • Protocol Proposals
  • Clinical Validation Plan/Clinical Performance Plan
  • Clinical Validation Report/Clinical Performance Report
  • Clinical Study Protocols (CSPs)
  • Clinical Study Reports (CSRs)
  • Intended Use Statements
  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • State-of-the-Art Determination (SOTA)
  • Scientific Validity Report (SVR)
  • Medical Assessment
  • Medical Opinion Documents
Team of writers collaborating at desk
Professional woman holding stack of folders and small cup

Devices

  • Clinical Evaluation Plans (CEPs)
  • Clinical Evaluation Reports (CERs)
  • Investigational Device Exemption (IDE)

Publications

  • Scientific Manuscripts/Abstracts
  • Posters
  • Literature Reviews/Summaries
  • Oral Presentations

Other Scientific Documents

  • Plain Language Documents (protocol synopses, results summaries)
  • Informed Consent Forms (ICFs)
  • Regulatory White Papers
  • Consumer Health Product Documents

Medical Writing Services  Frequently Asked Questions

Click on frequently asked questions about ProPharma's medical writing services and experience.

We provide medical writing services to pharmaceutical/biotech companies of all sizes (including small, mid-size, and big pharma).

The ProPharma medical writing process is an "author-driven" process that can be modified and customized to meet specific client needs. Our overall goals for each deliverable are to meet timelines, manage challenges, produce a high-quality document, and minimize cost.

At kickoff, the medical writer helps to develop the document timelines, establish team expectations and document strategy, identify potential risks, and establish a risk management plan if needed. During document development, the medical writer collects study documents, collaborates with the authoring team on document content and quality, and follows the communication plan.

The medical writer manages the document review cycles, including comment incorporation and adjudication in collaboration with the authoring team, ensures timeline integrity, and facilitates quality control (QC) reviews, final document approval, and electronic publishing, as necessary.

Yes, ProPharma medical writers collaborate closely with global cross-functional teams during all stages of document development, engaging at a level that meets each individual client’s needs.

In addition to content development, ProPharma writers are also trained to support publications strategy and project management. Our writers will drive timelines, manage meetings, and coordinate with both internal sponsor partners and external KOLs. They can assist your team with everything from researching target journals to creating graphics. They will proactively review Rules for Authors to ensure adherence to the guidelines and can also manage the journal submission. Our team is flexible in providing whatever services you need to support your publications.

ProPharma recruits and retains experienced medical writers, with routine training on our internal policies, SOPs, and work practice documents. Training on client-specific processes is provided as needed. Medical writing leadership mentors the medical writing staff to ensure consistency in performance, communication, and project/time management. Senior/peer reviews of documents provide continuous learning opportunities for writers to ensure quality and internal consistency of our work product. We designate document-specific SMEs who are available to answer questions about process, timelines, documentation, and best practices. We work together to answer questions internally to provide learning opportunities and minimize any interruption or burden on our clients.

ProPharma has also developed an extensive early talent and training program that provides hands-on, mentor-driven medical writing training and support for those interested in becoming medical writers. The foundational training program provides core knowledge and soft skills training (e.g., stakeholder management, communication, teamwork/collaboration, time/project management) through document-specific curriculum, hands-on exercises, shadowing, and direct mentoring designed to accelerate the learning curve and train the next generation of medical writers.

Have additional medical writing questions?

We'd be happy to talk with you
about your unique needs and goals.

News & Insights

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...

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

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

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

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...

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...

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

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

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 –...

Previous Post Arrow Next Post Arrow
%}
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