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What if you could select the right dose, population, study and program design – before you invest time and money in the trial?
Our Model-Based Drug Development team helps you minimize risk by showing you how different strategies could play out before you decide which one to implement. It’s a smarter approach to give your molecules, studies and overall portfolio the best chance of success.
Lifecycle Modeling & Simulation: Current Practice and Future Impact on Healthcare Innovation and Delivery
This paper discusses how the increasing availability of health data, improving analytic tools, and regulatory encouragement are facilitating wider use of modeling and simulation to address complex medical questions. The goal is to use models and simulations to test assumptions and make predictions that improve planning and decision-making across the full spectrum of therapeutic innovation.
Lifecycle Modeling & Simulation: Applications in Clinical Development
This paper explores the use of modeling and simulation to quantify problems and test assumptions in the clinical development process. Emerging applications are now being used to predict drug safety and efficacy, to plan individual trials and Phase I-III development programs, and to better manage research portfolios. These applications offer a glimpse of the biopharmaceutical industry’s modeling and simulation-informed future.
The Center for Statistics in Drug Development (CSDD) at Quintiles
The main statistical areas of the CSDD expertise are adaptive designs, model based drug development, missing data methods, data mining, subgroup analysis and biomarker discovery, multiplicity issues, and Bayesian methods and techniques. Read more about our services and hear about our work collaborating with Janssen on training and specialized consulting.
Model-Based Drug Development 101
In this on-demand webinar, Dr Seth Berry and Dr Russell Reeve explain and demonstrate how model-based drug development can help to improve communication across disciplines, to utilize the many data domains to improve drug development, and to make better, quantitative, data-driven decisions.
The Case for Early Cardiac Safety Data & Modeling
This webinar will provide insight into the latest scientific and regulatory thinking around the use of early-phase QT data and concentration QT modeling as a predictor of cardiac risk, ultimately improving decisions about further development and future study design.
Turnkey TQT Solutions
Whether you are planning a TQT study and needing design advice or if your drug has already hit a cardiac safety road bump and needs help dealing with false positive results, Quintiles Concentration-QT (C-QT) modeling services can help predict and provide clarity before making that next go / no-go decision.