
SERVICES

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
