Additional Medical Writing Services
Beyond core regulatory documentation, we offer a comprehensive range of specialized medical writing services to support your clinical development, scientific communications, and medical affairs needs.
Our Specialized Medical Writing Services
Tailored medical communication solutions for every stage of your product's lifecycle
Publication & Manuscripts
Clear, scientifically accurate, and impactful manuscript preparation that showcases your data effectively while adhering to publication guidelines and ethical practices.
Structured manuscripts detailing methods, results, and conclusions that meet target journal requirements.
Comprehensive literature reviews that synthesize existing knowledge and identify research gaps.
Strategic guidance on target journals, authorship, and publication timelines aligned with your objectives.
Expert response to reviewer comments and revision management to maximize acceptance rates.
Congress & Conference Materials
Compelling, scientifically accurate conference materials that effectively communicate your research findings to diverse scientific audiences.
Expertly crafted abstracts and visually engaging posters that highlight key findings within congress guidelines.
Clear, compelling slide decks and speaker notes that support effective data communication.
Comprehensive materials supporting sponsored scientific meetings and symposia.
Guidance on abstract submission strategy, congress selection, and communication planning.
Training & Educational Materials
Clear, accurate training documents that effectively communicate complex medical information to various stakeholders throughout your clinical program.
Comprehensive materials that ensure protocol understanding and consistent implementation across trial sites.
Clear, accessible materials explaining trial participation and procedures to potential participants.
Scientifically robust content that supports effective KOL engagement and scientific exchange.
Comprehensive briefing documents and presentations to maximize advisory board effectiveness.
Regulatory Correspondence
Strategic and scientifically sound communications with regulatory authorities that build productive relationships and advance your development programs.
Clear, data-driven responses to regulatory questions and information requests.
Comprehensive documentation to support productive regulatory authority meetings.
Strategic documents that frame development questions to optimize regulatory feedback.
Focused documentation that addresses potential regulatory concerns before formal submissions.
Our Medical Writing Approach
A systematic process that ensures quality, consistency, and strategic alignment
Strategic Planning
We begin by understanding your objectives, target audience, and key messages to develop a strategic communication plan.
Content Development
Our medical writers work with your data and key stakeholders to craft scientifically accurate, compelling content.
Review & Refinement
We manage collaborative review processes with subject matter experts, ensuring all stakeholder feedback is incorporated.
Quality Assurance
Our rigorous quality control process ensures accuracy, consistency, and adherence to guidelines before final delivery.
Medical Writing Case Studies
Examples of our specialized medical writing expertise in action
Developed a comprehensive publication plan resulting in 12 peer-reviewed publications over 18 months, effectively communicating the scientific story of a breakthrough immunotherapy.
Created an integrated congress strategy and materials that effectively communicated pivotal trial results across three major medical conferences.
Developed strategic briefing documents for an FDA Advisory Committee meeting that successfully addressed complex safety concerns and supported approval.
Frequently Asked Questions
Common questions about our specialized medical writing services
We adhere strictly to ICMJE, GPP3, and journal-specific guidelines. Our process includes transparent authorship determination, complete disclosure of medical writing support, and comprehensive data presentation to avoid publication bias. We'll work with your publication committee to ensure all ethical requirements are met.
Yes, we regularly develop comprehensive publication plans for complex clinical development programs. Our approach includes identifying key data communication opportunities, strategically selecting target journals and congresses, developing timelines aligned with data availability, and coordinating authorship across multiple publications.
We support a wide range of regulatory communications including responses to complete response letters, information requests, meeting briefing documents, scientific advice briefings, and pre-submission consultations. Our team has experience with FDA, EMA, PMDA, and other global regulatory authorities.
We match each project with writers who have relevant therapeutic area and document type expertise. For highly specialized topics, we collaborate with subject matter experts while applying our medical writing expertise to ensure the content is both scientifically accurate and effectively communicated.
We first identify the target audience's knowledge level and learning needs. Then we structure content with clear learning objectives, present information in a logical sequence using appropriate instructional design principles, and incorporate visual elements to enhance understanding. All materials undergo review for scientific accuracy and educational effectiveness.
Yes, we develop patient-facing materials including informed consent forms, trial participation guides, and educational resources. We apply plain language principles to ensure complex medical concepts are accessible without losing scientific accuracy, and can adapt the content for various health literacy levels as needed.
Ready to enhance your scientific communications?
Contact us today to discuss how our specialized medical writing services can support your clinical development and scientific communication needs.