Computed Tomography (CT) diagnostic scans are performed on thousands of patients daily throughout the world. CT scanning suites are under multiple pressures to optimize their process and improve their financial situations. The diagnostic value of certain scans can be enhanced by the use of intravenous iodinated contrast agents (IVCA) as they allow for increased anatomical visualization. A supplier of IVCAs contacted ParagonRx to map the administration of these agents to help identify ways to help optimize suite operation. (more…)
Archive for the ‘General’ Category
Computed Tomography (CT) Imaging Ethnography
Wednesday, September 29th, 2010Grounding Your REMS in a Science-Based Approach – The ParagonRx RxFMEA® Approach to Assessing Medication-Use Risk
Wednesday, April 7th, 2010In 2001, ParagonRx first employed the science-based risk assessment methodology Failure Mode and Effect Analysis (FMEA) to proactively assess patient safety in the emerging field of Pharmaceutical Risk Management. While a novel approach for assessing drug safety issues, FMEA has a long history in other risk intensive industries used to mitigate process and design failures, including the aerospace, military, nuclear, and even pharmaceutical manufacturing. Research into how FMEA was used to mitigate risks across other industries and references made in FDA Draft RiskMAP Guidance, provided the rational for applying FMEA to pharmaceutical product and patient safety. RxFMEA®, ParagonRx’s proprietary adaption of the FMEA process, applies the principles of process mapping complex systems and systematically evaluating a process for potential failures. RxFMEA® is a proactive, bottom-up assessment that identifies the behavioral causes of medication use failures and prioritizes interventional opportunities to mitigate adverse events. RxFMEA® was specifically designed as a Pharmaceutical Risk Management tool and is now utilized in REMS development for the pharmaceutical and biotech industries. (more…)
Organizing for REMS Effectiveness: A View from the Field
Tuesday, March 30th, 2010- Guest blog by Andrea J. Simon, PhD -
This blog by Andrea Simon, PhD, a corporate anthropologist, is one in a series that ParagonRx has initiated to help our readers better understand some of the trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance. We know you will find them of value and encourage you to comment on them.
In April, ParagonRx is hosting its Wednesday FoREMS webinar on the topic of organizing to effectively manage Risk Evaluation and Mitigation Strategies (REMS). And, in May, the Wednesday FoREMS will host a panel of industry leaders discussing how their organizations are building REMS capabilities and resourcing them in their product development and commercialization functions. In preparation for these upcoming webinars, I thought I would share with you some of my observations from the field and encourage you to share your own company’s perspectives on how you are reorganizing to create and effectively manage REMS. (more…)
inVentiv Advance Insights will be presenting at the AMCP 22nd Annual Meeting and Showcase
Friday, March 26th, 2010Jennifer Restivo, VP and Managing Director, Managed Markets at inVentiv Advance Insights, and Kevin Cast, VP, Pharmaceutical Sales at ESI-Curascript, will discuss Risk Evaluation and Mitigation Strategies (REMS). The podium presentation is scheduled on Friday, April 9, 2:45 PM – 3:45 PM. Please check your program schedule for location.
The session will assess the current and future impact of emerging REMS trends. Jennifer and Kevin will present learnings, based on original research, from manufacturers and payers, as well as provide an overview of key considerations for optimal REMS implementation. (more…)
General Blog Comments
Thursday, January 1st, 2009Please let us know what you think…
