Medical Writing: Clear Communication in Complex Regulations
Scientific Precision in Every Document
The clinical strategy and development team is an international group of experienced professionals trained in clinical medicine and research, (molecular) biology, and pharmaceutical sciences. Their extensive scientific experience in industry and academia will bring your clinical development projects to success.
The team offers hands-on support with in-depth consultancy and medical writing for pharmaceutical products and medical devices:
Pharmaceutical Products
Clinical development
- Clinical development strategy
- Clinical development planning (scientific and economic)
- Clinical study synopsis and protocol
- Investigator´s brochures
- Project feasibility assessment and gap analysis
- Scientific justification for reclassification of products (Rx- and OTC-switch)
- Biowaiver justification
Clinical trial
- Clinical trial planning, management, and oversight
- Clinical trial application
- Compilation, maintenance, and archiving of clinical trial masterfiles
- Legal representative in the EU
- Evaluation and interpretation of clinical trial results
Scientific advice procedures (EMA, national competent authorities)
- Strategy
- Briefing documentation
- Organisation and support of procedures
Marketing authorisation procedures
- Dossier preparation (CTD Ms 2.5, 2.7, 5)
- Product information texts
- Risk management plan (M 1.8.2)
- Handling of assessment reports
Medical & scientific writing
- Systematic literature searches
- Drafting of scientific articles for publication
Paediatric investigational plans (PIP)
Orphan drug designations
- Protocol assistance for orphan drugs
Due diligence for in-licensing candidates
Identification of qualified service partners, key opinion leaders and scientific experts
Medical Devices
Clinical investigation
- Gap analysis of clinical data set
- Clinical investigation synopsis and clinical investigation plan (CIP)
- Investigator’s brochure
- Application / notification
- Communication with ethics committees and authorities
- Clinical investigation oversight, evaluation and reporting
Clinical evaluation (MDR EU 2017/745) / Performance evaluation (IVDR (EU 2017/746)
- Preparation of a clinical / performance evaluation plan (CEP / PEP)
- Clinical / performance evaluation report (CER / PER)
- Summary of safety and clinical performance (SSCP), Summary of safety and clinical performance (SSP)
- Regulatory assessments and gap analysis for project assessments
Post-market surveillance
- Post-market surveillance plan
- Post-market surveillance report / PSUR
- Post-market clinical follow-up (PMCF) plan and report / Post-market performance follow-up (PMPF) plan and report
- Systematic literature search, search in vigilance databases, analysis of data
Trainings / workshops on MDR requirements for:
- Clinical evaluation, post-market surveillance, post-market-clinical follow-up
Due diligence for in-licensing candidates
Have a question concerning Clinical Development? contact Dr. Andrea Niese.
