product development support for life science companies

 

 

 

clinical development

  • clinical program: scientific rationale, medical need, clinical development plan, centre selection, post-marketing programs
  • interpretation & benchmarking of findings and results
  • health economics (HE): data collection, interpretation of results and HE impact

medical affairs

  • expert engagement: expert programs, in-depth interviews, workshops & panels
  • clinical/medical communication: promotional materials, congresses & symposia
  • in-company support: medical/scientific training, SOP development, pharmacovigilance activities

business strategy

  • indication selection: scientific, medical & commercial rationale, strategic advice
  • competitive environment: competitive landscape, clinical pathways & standard practice, product positioning
  • market potential: realistic market potential, sensitivity analysis
  • business case development in support of partnering activities, value dossier

market access

  • support local reimbursement, clinical/HE package, market access plan

project management

  • initiation: aim, strategic requirements, positioning, scope, project team, charter
  • planning: objectives & project plan, interdepencies, resources, timelines
  • execution: coordination &  monitoring, team motivation, risk management, updating project plan
  • closing: project outcomes & impact, lessons learned, reporting