Optimizing CRA Deployment in Global Clinical Trials

This audio conference will provide insight into how to drive ROI by optimizing CRA deployment and data management staff planning. Specifically, the presentation will detail the critical patient data that should be captured in your IVR system in order to maximize the efficiency and organization of CRA site visits. This data can then be linked with your clinical trial management system to project the data workload accumulated at investigator sites.

The speaker will provide practical examples of how this information has been used to optimize deployment of CRAs to investigator sites and to drive efficiencies in those site visits. Furthermore, the presentation will examine how the IVRS data stream can also be used to determine the amount of data management staff that will be required in the trial. More effective utilization of an IVRS data stream can enhance visibility into trial performance and drive cost-saving efficiencies.

Optimizing CRA Deployment in Global Clinical Trials was presented on 2007-11-15 by Marie Snell, with Covance and is available for download at www.fxconferences.com

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices

The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference examines how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices was presented on 2007-02-15 and is available for download at www.fxconferences.com

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.

In this audio conference we will discuss the key items of an evidence-based approach to feasibility and ultimately, site and country selection.

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines is being presented by Kent Thoelke, Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs, with PRA International and airs on Wednesday, March 25, 2009. For more details or to register, please visit our site www.fxconferences.com

Hazard Analysis for Medical Devices Under IEC60601 and ISO14971

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1)credit toward a participant's RAC recertification upon completion.

21 Steps to Easier Globalization through Better Writing

Going global? Many of the problems encountered during the globalization process can be traced back to the earliest stages of developing product documentation. The good news is most of these problems can be avoided by following a few basic rules.

John Smart has spent over two decades helping companies market to 218 countries. In this presentation, he will describe the 21 most common problems encountered in writing for a global audience, identifying each type of error, describing the problem and showing how to make corrections. The presentation will use real-life examples to highlight potential cultural problems, including inappropriate number and color references, and the confusing use of dates and numbers. Attendees will be able to put the conference material to immediate use in improving their technical literature.

21 Steps to Easier Globalization through Better Writing is previously recorded, and available for download at www.fxconferences.com