Clinical Leader Newsletter: Risk Assessment In Risk-Based Monitoring

What Pharma Is Learning From Retail: Data, Engagement Go Hand-In-Hand By Anna Rose Welch, Associate Editor, Clinical Leader Just as the retail industry grows increasingly customer-centric, the pharma industry is undergoing its own revolution to become patient-centric. As in the retail space, where customers have become more willing to share personal information with stores to see more benefits and deals, patients, too, are showing their willingness to voice their needs and dedicate their data to studies in order to see greater medical benefit in the long run. Sponsor Featured Articles The Role Of Observational Research And Patient Registries In Evidence Generation By Michael F. Murphy, Lorna M. Graham, and Alexandre Malouvier The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. Neither orderly, nor fully rational, these often conflicting perspectives require access to a portfolio of interventional and observational research designs subserving different objectives and tiered in importance and timing during the drug development cycle. 3 CRO Trust Markers In 2015 By Aaron Mazze, Merge eClinical How will your CRO fare in 2015? It depends on how your sponsor companies manage a bevy of industry challenges. R&D costs, pricing pressures, and regulatory developments are part of the mix. Investigator Payments: Channels, Cycle Time, And Benchmarks By Mathini Ilancheran, Senior Research Analyst- Clinical Research, Beroe Inc. Considering the fair market value for investigator payments per trial costs is crucial in order to avoid higher payment, which may result in financial strain on the sponsor. Seeing Around Corners: Risk Assessment Is The Foundation Of Risk-Based Monitoring By Jeff Fetterman and Michael Macri, inVentiv Health Clinical It stands to reason: You can't properly monitor risk until you've first identified and assessed potential risk. There is consensus among regulators and industry leaders that risk assessment is the foundation of all subsequent planning for risk-based monitoring. The BRCAvantage Test For Breast Cancer Clinical Trial Testing Resources Mystery Meds: Counterfeit Drugs Remain A Supply-Chain Risk In Emerging Markets Global Study Reveals The Future Of Temperature-Control Packaging Applications Of Metabolomics Poster Featured Webinar Webinar: Preventing Drug Shortages In Clinical Trials March 19, 2015, at 11:00 a.m. EDT Have you ever experienced a drug shortage in a clinical trial? The affects can fall anywhere between small and fixable (i.e., a minor delay or a few rescheduled site visits) to big and catastrophic such as when serious supply issues put a study at risk. The good news is that drug shortages are preventable. Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine.