¨ Design integrated, multi-disciplinary adaptive drug development plans

¨ Utilize Clinical Trial Simulation (drug / disease modeling) to compare the robustness of various study designs

¨ Quantitative decision support

· Modeling of pooled proprietary data

à Including Real-time data analysis

· Modeling of competitor data

· Quantitative assessment (including uncertainty) of current product profile with or without comparator data

¨ Program reviews

¨ Independent assessment of key go / no-go decisions

¨ Regulatory strategy for products and Health Authority meetings (e.g. End-of-Phase 2a meetings)

¨ Adaptive Drug Development Implementation and Project Management (project team) with the focus on knowledge and investment inflection points

· Clinical, Non-Clinical, CMC*

¨ Clinical trial management and/or oversight

· Study Management

· Medical Monitoring / Safety

· Vendor selection, budgets and contracts

· Biostatistics / Programming and reporting

· Real-time data acquisition / analysis

· Supply chain management oversight

· Data management*

· Site Monitoring*

· QA*

¨ Clinical, pre-clinical PK-PD and Toxicokinetic analysis and reporting

¨ Manage regulatory communications, meetings and filings