Clinical development of drugs & vaccines

Supporting the delivery of qualified biomarkers

• Identify suitable biomarker candidates based on science
• Evaluate their regulatory and technical utility for clinical studies
• Provide project-specific biomarker/serology strategy for drugs and vaccines
• Set-up GCP-compliant project management and outcontracting of laboratory work
• Suggest validation strategy for biomarker assays based on regulations (FDA, EMA)
• Evaluation and publication of clinical (digital) biomarker data

Supporting the Clinical Development Process and Medical Affairs

• Implement biomarkers in clinical study protocols and medical plan
• Foster personalized medicine and companion diagnostics approach
• Support investigator-initiated trials –manage relationship with KOL
• Support planning and execution of epidemiology studies
• R&D strategy for life cycle management of drugs

Supporting pharma, diagnostics and biotech business

• Support analysis of the project portfolio of a company
• Evaluate feasibility, medical and commercial value of projects
• Support licensing of external development opportunities
• Coaching of startups: business plan, R&D strategy
• Liaise with investment experts to capitalize great ideas