Life Sciences

• Article CDISC Enables Efficient Streamlining of Clinical Trial Safety EvaluationIn this paper we discuss clinical trial summary information and follow the flow of FDA New Drug Application (NDA) submissions, Clinical Reviews (CR) and Biosimilar Multi-disciplinary Evaluation and Review (BMER) to reveal how the various domains of SDTM and ADaM are used to assess drug safety.
• Technically Speaking Modernization Updates in JMP ClinicalChris Kirchberg demonstrates how you can use the new reports for safety signal identification, reporting to regulatory agencies, and/or sharing with colleagues, quickly, easily, and without programming.
• Customer Story F-star TherapeuticsStatistical approaches to experimentation open the door to the exploration of novel biology.
• e-Book Cautionary Tales in Designed ExperimentsThe beauty of DOE is about learning—from mistakes, from trying new things, and from working with others.. In this free e-book legendary author Dr. David Salsburg looks at the history of DOE and shares what to do (and what not to do) to successfully execute designed experiments.
• Book Chapter Dark DataIn Dark Data, Dr. Hand explores the many ways we can be blind to missing or unseen data and how, in our rush to be a data-driven society, we might be missing things that matter, leading to dangerous decisions that can sometimes have disastrous consequences.
• Book Chapter Art of StatisticsIn this introduction from his book, Art of Statistics, Sir David Spiegelhalter outlines why it's critically important to use statistical science to answer the kind of questions that arise when we want to better understand the world.
• White Paper Optimizing Pharmaceutical Production Processes Using Quality by Design MethodsGood news! Did you know that your quality by design goals can be derived in a straightforward way, the results can be easy to verify and that this method allows for further improvement of the processes without the need for re-registration? Find out more with this case study from pharma.
• Article Guaranteeing the Quality, Efficacy and Safety of PharmaceuticalsLearn best practices for ensuring quality, efficacy and safety across all levels of drug development and manufacturing.
• Technically Speaking QbD: Using DOE to Increase Knowledge of the Process and Design SpaceDiscover when to apply design of experiments and how to identify different strategies to suit a variety of experimental needs.
• Technically Speaking Analytical Method DevelopmentDiscover a new approach that will enable to you to expend as few resources as possible while maximizing the information you get from an assay.
• Technically Speaking Pharmaceutical Method TransferConduct a successful analytical method transfer with time-saving statistical methods. In this webinar, you’ll learn new best practices to help streamline testing protocols.
• Technically Speaking Visualization and Analysis in Oncology Trials Using RECISTLearn how specialized interactive visualization reports can help you more effectively evaluate early efficacy signals in oncology therapeutic studies.
• Book Chapter Pharmaceutical Quality by Design Using JMPLearn how QbD and good data visualization is used in early stage product development to help pharma organizations create more effective quality controls.
• White Paper Big Data, Pharma 4.0 and Process ModelingHow can you prepare for Industry 4.0? This paper outlines how to improve process knowledge, close the gaps for legacy products and set the foundation for big data use.
• Analytically Speaking Operational Excellence in Pharmaceutical ManufacturingPer Vase of pharmaceutical engineering company NNE provides a scientific approach to process optimization.
• Technically Speaking Pharmaceutical Product StabilityLearn how to navigate pharmaceutical regulatory requirements with robust analytics.
• Explorers Improving Product Reliability With Quality By DesignLearn leading-edge new strategies to improve product reliability in the pharmaceutical industry.
• Explorers Reproducible Experimentation for Diagnostically Driven Drug ResearchMatt Wongchenko and Russ Wolfinger discuss strategies for leveraging data and statistical tools to achieve better, reproducible science.
• Explorers Modern Clinical Monitoring And Quality By DesignLearn the Impact of regulatory guidance on Analytics, the Modern Techniques in Clinical Trial Monitoring and how to use QbD to increase clinical understanding.
• Technically Speaking Clinical Trial Safety Analysis With JMP ClinicalConsolidate your clinical trial workflows by providing interactive reviews for medical monitors, reviewers and writers. This randomized controlled trial case study shows you how!
• Life Sciences State of the Art Strategies for Clinical Trial MonitoringIdentify the source of data quality issues and reduce trial costs (while improving your process)!
• Book Chapter Detecting Fraud at the Clinical SiteOrganizations find a better way to protect participants in clinical trials. Learn the graphical and statistical approaches being used to identify site- and patient-perpetrated fraud.
• Life Sciences Quality by Design and the Life SciencesJoin Principal Consultant Heath Rushing as he examines Installation Qualification (IQ), Operation Qualification (OP), Performance Qualification (PQ) and Quality by Design (QbD) within the development of medical devices.
• Life Sciences Multiple Testing Correction: Why, When and HowCalling all JMP Clinical and Genomics Users: Learn how to administer correction of significance results to avoid false claims.
• Life Sciences Adverse Event Signal Detection Using Bayesian Hierarchical ModelingA tutorial on how to use JMP is used to streamline the review of MCMC diagnostics and the analysis of posterior probabilities.
• Life Sciences Gene Expression Analysis for Absolute BeginnersDon't have a statistical background but want to understand analysis of gene expression data? No problem! This intro will walk you through the basic steps.
• Life Sciences Predictive Modeling in the Life SciencesThis webinar reviews tools for comparing a large pool of potential models and ways to identify the usefulness of a particular model.
• Life Sciences Identifying Drug-Induced Liver InjuryDid you know that Drug-induced liver injury (DILI) is the most common cause of safety-related drug marketing withdrawals? See how JMP Clinical can uncover cases of DILI using Hy’s Law.
• Life Sciences Fraud Detection in Clinical TrialsAvoid putting your clinical development program at risk. See the features in JMP Clinical that help identify unusual and potentially fraudulent data.
• Life Sciences Meta-Analysis of Genomics DataLearn how to combine research results from multiple studies in JMP Genomics, both for gene expression data and genetic association studies (GWAS).
• White Paper Generating Adverse Event Narratives Using JMP ClinicalNew analytical process available to streamline the time-consuming task of creating patient narratives. Learn more about this function in JMP Clinical.