Clinical Development
Moving a small or large molecule from bench to bedside is a lengthy and resource intensive process that also comes with great risk. Products would never reach market without the expertise of clinical development professionals to address nonclinical and clinical strategy, medical / regulatory writing, and commercialization.
Clinical Development Consulting Services
- Clinical Development Strategy
- Clinical Development Plans
- Preparing Dossiers & Submissions
- Understanding Current Standards of Care
- Mapping Competitive Landscape Medical
- Support for Agency Interactions
- Developing Protocols
- Developing Target Product Profiles
- Regulatory Support GCP Compliance
- Developing Clinical SOP’s
- Medical Affairs (Pre and Post-Launch)
- Pharmacovigilance Consultancy Medical Monitoring
- Clinical Data Cleaning, Analysis, and Review
- Clinical Development MD ad hoc Consulting
- Clinical Research Scientist ad hoc Consulting