Strategic Medical Writing
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Strategic Medical Writing 〰️
Regulatory Writing
Optimized interactions with Health Authorities
Understanding of the operational interplay
Overarching cross-functional perspective
Shepherding teams towards a timely & high-quality submission
Facing adversity with a creative problem-solving
ClinOps perspective to optimize data collection
Oversight of regulatory submission deliverables
Clinical development
Pediatric Plans (EMA, FDA)
Clinical Modules 2.5, 2.7
Briefing Documents (EMA, FDA, CDE, PMDA)
Answers to Objections
FDA Diversity Plan
Protocol & Synopsis + Informed Consents
Study materials: slide decks for SIVs, newsletters to sites, instructions for patients & sites
Investigator’s Brochures
Consistency checks of trial documentation (e.g., CRFs, SAPs) with a ClinOps eye
Study conduct optimization
Safety overviews
Investigator’s Brochure
Benefit-Risk Strategy Documents
Summary of product characteristics
Study outputs
Clinical Study Reports
Patient narratives
Biomarker Reports
Medical Devices
Clinical Evaluation Reports
Clinal Investigational Plans & Reports
Instructions for Use
Technical Dossiers