SLSC can support you with developing the following documents:
- Clinical study protocols:
- First in Human Studies
- Clinical Pharmacology Studies (hepatic impairment, renal impairment, pediatric, elderly, food interaction, gender, TQT, etc.)
- Clinical Pharmacokinetic Studies (absolute bioavailability, relative bioavailability, bioequivalence, DDIs, etc.)
- Biomarker- / Proof of Mechanism Studies
- Proof of Concept Studies
- Parallel Indication Expansion Studies
- Multi-Indication Umbrella Studies
- Informed consent forms
- Clinical study reports
- FDA/EMA briefing documents
- Investigator’s brochures
- Scientific Abstracts, Posters and Peer-reviewed Journal Articles
- Executive summaries for efficacy or safety
- Patient narratives