Clinical research
- Planning of clinical drug development for phases II – IV and post marketing
- Study design and protocol / Case Record Form (CRF) development
- Investigator Recruitment
- Monitoring of clinical studies according to GCP
- Study Report writing
- Quality Assurance audits and
- Monitor Training for GCP
Pharmaceutical project management
- R&D portfolio analysis, scientific evaluation of projects
- Development plans
- Network plans, project information systems, ~ – databases
- Establishing, coaching, monitoring and controlling of project teams
- Training for teamwork
- Re-organising R&D management by introduction of a PjM system
–> what means pharmaceutical project management with P.SS.TÂ ?
