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medical writing services

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

Medical writing services header
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.

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October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

June 16, 2023

Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC

Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

September 28, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

September 28, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

September 28, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands

June 12, 2023

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Flyers Functional Service Provider (FSP) Value Proposition

June 21, 2023

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Flyers Labeling Development & Intelligence

June 21, 2023

Labeling Development & Intelligence

Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses

June 27, 2023

Enhancing Site Capacity for Clinical Trials with DCT Nurses

Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...

Whitepapers Compliance Auditing: Diving into Common Critical Findings

July 31, 2023

Compliance Auditing: Diving into Common Critical Findings

Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...

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