The Medpace medical writing team is involved at project initiation, working closely with Medical Monitors and Statisticians to develop study protocols, clinical/statistical study reports, and integrated, submission-ready documents according to regulatory guidelines. This allows them to develop an accurate description of your data to ensure that every phase of trial is correctly focused for maximum results. The Medpace medical writing team also writes and edits manuscripts in a variety of therapeutic areas, with a proven track record of publication in major peer-reviewed journals.
Medpace Medical Writers
- Collaborate with project teams to produce concise and comprehensive clinical documents.
- Integrate pertinent information from statistical analyses into clinical study reports.
- Deliver all documentation in electronic formats, according to Sponsor standard operating procedures, report templates, and preferred writing style.
- Provide accurate documents through an intensive internal review and quality control process.
- Prepare electronic submission-ready reports and regulatory documents meeting FDA guidelines.
Marketing Approval Applications
Medpace Medical Writers have produced more New Drug Applications (NDAs) submissions resulting in FDA approvals in the past decade than most of our competition. Our medical writing staff has extensive experience in preparing the clinical components of Marketing Approval Applications in Common Technical Document (CTD) format, including:
- Clinical Study Reports (Phase I-IV)
- Integrated Summaries of Efficacy and Safety
- Clinical Summaries
- Biopharmaceutical and Clinical Pharmacology Sections
- Clinical Overviews
Investigational New Drug (IND)
Medpace Medical Writers have deep insight into the specific areas of drug approval and understand the appropriate methodologies for Investigational New Drug (IND) applications. Our experts know what FDA reviewers are looking for and deliver superior medical writing, data analysis, and research skills to your project.
- Pre-IND and Pre-NDA meetings including briefing book preparation, meeting support and attendance, and regulatory strategy guidance
- IND submission and IND maintenance including submission and tracking of IND Safety Reports, Annual Reports, and Amendments
Every document produced by the Medical Writers at Medpace is reviewed by an internal team comprising of a Medical Monitor, Statistician, and other experts to ensure that it is thorough, clinically accurate, and relevant. Each document undergoes a rigorous quality control review process to ensure accurate reporting of data, overall completeness, and correct grammar usage.
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