Strategic Consulting Services —
Our Approach
SCS is the market leader in the strategic application of quantitative models to improve drug development strategy and decision-making. The model-based methodology advanced by Pharsight® continues to gain momentum and relevance in today’s industry climate of declining approvals, notable product failures and increased public and regulatory scrutiny.
SCS Methodology:
In its May 2004 report, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, the Food and Drug Administration (FDA) recognized systematic application of model-based drug development as an important approach to improving drug development knowledge management and development decision-making.
From its inception, our strategic, decision-focused approach has allowed Pharsight to:
- Integrate complementary drug development disciplines, novel approaches and advanced software technology
- Maximize the value of available information to help quantify knowledge and uncertainty
- Include your proprietary data as well as public-source data (e.g., from the literature, previous trials, related compounds/analogues, competitors)
- Establish decision strategies that explicitly consider tradeoffs among multiple measures of risk, cost and benefit (clinical efficacy, safety, commercial benefit, societal impact)
- Enhance communication of development strategies, recommendations, and decisions
- Enhance the value derived from modeling and simulation through mentoring and training