psn provides a professional consulting service by senior executive experts from the pharma and biotech industries. For many years, psn has maintained agreements with a comprehensive panel of well-recognized experts that work cross-functionally on several disciplines and therapeutic areas:
- Drug development programs
- Medical assessments and information
- Evaluation of in-licensing and acquisition opportunities
- Clinical development assessments and plans
- Pre-clinical development assessments and plans
- Regulatory strategies, procedures, assessments and plans
- Pharmaceutical development and quality both small molecules and protein
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psn can offer assistance with medical writing throughout Europe and the US. All reports are prepared in strict accordance with US/EU/ICH guidelines and regulations.
A few examples include:
- Protocol design/review and amendments
- CRF design and preparation
- Clinical study reports
- Statistical reports
- Integrated summaries of safety and efficacy
- Patient informed consent
- Patient diaries
- Key opinion leader reports
- Investigator brochures
- Medical texts for package leaflets
- Scientific articles
Documents may be prepared in multitude of languages.