Strategy  ♦  Clinical  ♦  Regulatory  ♦  Reimbursement

   Planning     →      R&D      →       Approval      →     Commercialization

 

Strategy

• Management consulting for life sciences and health care companies
• Strategic planning, priority setting, due-diligence
• Evaluation of pre- and post-market strategies
• Companion diagnostic development (strategic partnering, project planning, and oversight)
• Product development and positioning support, identification of market access opportunities

 

Clinical

• Design and planning for clinical trials, including alignment with diagnostic partner
• Creation of trial protocols, IRB submissions, and other clinical documents
• Patient-facing documents, including surveys, patient-reported outcomes forms
• Trial site identification, setup and management, patient identification and recruitment strategies
• Clinical reports and regulatory documentation

 

Regulatory

• Regulatory strategy and competitive intelligence
• Planning of interactions with regulatory authorities
• Identification of regulatory pathways for drugs and (companion) diagnostics
• Preparation, writing and/or review of regulatory documentation and submissions
Regulatory representation

 

Reimbrusement

• Creating value proposition relevant for payers
• Design of health economics and outcomes-based research projects
• Identification of real-world, payer-focused research sites and opportunities
• Evaluation of reimbursement environment
• Market access strategies