Begin with the End in Mind - Meeting an Unmet Medical Need
Evidence is used to support one or more needs within the market.
Therapeutic Need
- Breakthrough vs Incremental value
- Early vs late stage disease
- 1st vs last to market
Ease of Use Need
- Therapy delivery
- Product acquisition
- Patient compliance
Access
- Cost
- Reimbursement
- Alternative options
Where We Excel
Clinical Research
Medical/Scientific Affairs
Medical/Scientific Affairs
- Clinical research strategy, portfolio development and management
- Designing-executing phase I-IV clinical research and real-world evidence studies
- Developed and lead investigator-initiated research programs
- Analyzing complex medical/scientific data interpreting clinical and market impact
- Evidence gaps analysis, post market clinical strategy.
- Extensive medical expertise in cardiovascular, neuroscience, medication safety and interventional oncology
- GCP, IRB, and SOP experience
Medical/Scientific Affairs
Medical/Scientific Affairs
Medical/Scientific Affairs
- Creating medical strategy and evidence generation/dissemination plans
- Medical affairs operations and MSL field leadership creating & leading teams
- Designing and executing field medical communications
- Creating best in class medical information service
- Launching new therapies creating education programs,
- Creating innovative education and training programs for physicians, scientists and students
- Creating-executing scientific exchange campaigns educating healthcare providers, systems and payers on the safe and effective use of therapies
- Cost effectiveness and health outcomes evidence planning, execution, communication and educational campaigns
Post Market Regulatory
Medical/Scientific Affairs
Post Market Regulatory
- Creating quality management system for software as a medical device; FDA part 820 and ISO 13485 experience
- Promotional review, medical safety, CAPA, Quality and FDA compliance
- FDA 483 and consent decree experience
- Regulatory strategy, planning and execution for software as a medical device