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.
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 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.
With access to a large pool of experienced medical writing resources, we can scale up as needed to accommodate any demand.
We believe quality is intentional. Using a documented and systematic approach, we build quality into each document as it evolves through its lifecycle.
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 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)
- 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
- Pharmacology, Pharmacokinetic, and Toxicology Reports (in vivo/in vitro)
- Bioanalytical Reports
- 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
- Clinical Evaluation Plans (CEPs)
- Clinical Evaluation Reports (CERs)
- Investigational Device Exemption (IDE)
- Scientific Manuscripts/Abstracts
- 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.
Have additional medical writing questions?
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about your unique needs and goals.
News & Insights
News & Insights
September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...