Drug Development Stewardship and Strategic Planning

Drug Development Gap Analysis

Setting the Right Strategy As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Certara’s solution evaluates the 40 different questions […]

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Drug Development and Clinical Pharmacology Strategy

Changing the Game in Drug Development through a Strategic and Programmatic Approach Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. But, this approach risks missing opportunities to develop medicines faster and better. And lacking a holistic and strategic roadmap to achieve milestones […]

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Clinical Outcomes Databases for Specific Therapeutic Areas

About our Clinical Trial Outcomes Databases Our Clinical Trial Outcomes Databases form a quantitative framework to leverage valuable external data, providing key development insights to maximize the probability of success for a new drug. Comparative effectiveness Endpoint and subpopulation relationships Biomarker efficacy and safety outcome Trial design optimization Competitive analysis and commercial viability Gathering, formatting, […]

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Clinical Trial Outcomes Databases

Clinical Trial Outcomes Databases Quantify Your Competitive Edge Along the development path of a compound, sponsors make critical decisions to ensure drug approval and market success. Success depends not only on the drug’s performance, but also on the competitive landscape, requiring reliable assessments—now and for the future—of your competition. Gain Faster Time to Insight What […]

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Orphan Drug Development

Orphan Drugs: Unique Challenges Require Unique Development Approaches Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patient populations are difficult to identify and recruit for clinical trials. Many orphan diseases are genetic. Often these patients have complex phenotypes that react very differently to proposed treatment […]

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Model-based Meta-analysis

An Innovative Strategy to Make Better Use of Available Data The difference between getting a new medication to patients, and it ending up in the scrap heap of failed programs lies in making the right choices. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How […]

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Simcyp PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) Modeling: Getting Real Answers from Virtual Populations A recent FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners: “Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, […]

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