Addressing Cost Pressures in Late-Phase Research

is being presented by Dr. Max Horneck, Head of eClinical Services, with Wega Informatik AG and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

There is no question that gathering real-life data on approved drug products is of vital importance. Data collected for marketed drugs is needed to generate thorough knowledge of the safety, efficacy and effectiveness. The challenge for clinical operations arises from significant cost pressure in post-authorization studies, while attempting to maintain an adequate level of quality and achieving study targets. Experience has shown that simply mapping procedures from early to late phase does not give the desired results. Budgets tend to be overstressed while targets and quality remain in danger.

In this audio conference, our speaker draws upon almost two decades of clinical experience and provides insight on how to to effectively maintain control of the study conduct and quality of data with reduced efforts by the use of risk mitigation, regional service providers and business intelligence. This presentation enables the attendees to safely plan and conduct late phase studies at significantly reduced costs while maintaining compliance with current regulations at the desired level of quality.

Enhanced Monitoring Tools and Strategies to Optimize Productivity and Compliance

is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Tuesday, January 11th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.

Integrating Data Streams for More Efficient Trials

Are you interested in faster clinical trials and improved data quality? For most sponsors and CROs, the answer would be an emphatic "Yes!". Managing a clinical trial effectively requires collaboration across multiple trial requirements. This presentation illustrates how IVR/IWR and lab data can be integrated and reconciled in real-time, improving the speed and overall quality of trial results. The presentation uses real-life case studies to demonstrate the trial efficiencies and benefits gained when combining labs and IVR/IWR data in real-time. The speaker also discusses technical considerations to enable an integrated data stream.

Integrating Data Streams for More Efficient Trials was presented by Vicky Czarnik, Senior Technical Strategy Manager, with Covance IVRS and aired on 2008-11-06. For more details or to download this event, please visit our site at www.fxconferences.com

Real-Time Adverse Event Analysis Using IVR

This audio conference provides an overview of practical considerations regarding the challenges of obtaining adverse event (AE) data, particularly in real-time. A fundamental challenge in the adverse event reporting arena is a lack of, or incorrect, information on patient exposure data and AE incident reporting.

This presentation suggests a strategy for utilizing your IVRS data stream to enhance understanding of patient exposure and enable real-time, proactive decision-making on the progress of the clinical trial. Data already captured in your IVR can provide significant insight into clinical trial performance and improve your understanding of adverse events in your trial. The strategy presented in this audio conference enables you to immediately improve your understanding of AEs without any additional capital expenditure.

Real-Time Adverse Event Analysis Using IVR was presented by Hal Ward, Executive Director Global Head of Drug Safety, with Covance and aired on 2007-08-15. For more details, or to download this conference, please visit our site at www.fxconferences.com

Conducting Drug Trials in Asia Pacific

With constant pressure to reduce the cost of drug development and to find eligible subjects for clinical trials, developing areas of the world are of increasing interest to trial sponsors. But how does the quality of data compare with traditional sites? And what about the rate of recruitment? Do these alternative sites really offer a substantial benefit in terms of time and cost savings?

This presentation, the second in a series featuring speakers from Covance addressing alternative site selection, focuses on the opportunities and the reality of performing clinical trials in the Asia Pacific market.

Conducting Drug Trials in Asia Pacific was presented by Dr. Helen Ormandy, Director, Centres of Excellence, with Covance Asia Pacific and aired on 2006-05-04. For more details or to download this conference, please visit our site at www.fxconferences.com

To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com

Considering Human Factors in Designing Medical Device Trials

Increasingly, the FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design. Evaluating the human interface in the user environment produces critical data for pre-market applications to the FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

Considering Human Factors in Designing Medical Device Trials is being presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and airs on Thursday, May 7, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

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

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs

Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs is being presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Wednesday, February 25th, 2009. For more details or to register, please visit our site at www.fxconferences.com

European Data Privacy: Are you compliant?

This audio conference will provide an overview of the importance of data privacy in Europe for companies operating internationally and using a global HRIS application. Are you compliant? Do you have the appropriate policies in place to secure personal and sensitive data about your employees, contractors, customers and suppliers? What do you need to pay attention to?

European Data Privacy: Are you compliant? is being presented by Pascale Viret, Director of Human Resources, EMEA, with Haemonetics Corporation and airs on Wednesday, March 4th, 2009. For more details, please visit our site www.fxconferences.com

How to Evaluate Your RiskMAP

A key element of any Risk Minimization Action Plan (RiskMAP) is the description of ways in which the Sponsor will determine if the risk minimization efforts are working.

In this audio conference, Dr. Stemhagen discusses strategies and approaches for evaluating RiskMAPs, in conjunction with the types of risk minimization "tools" that can be implemented. She also describes the range of evaluation methods that can be used to evaluate risk management interventions, such as use of existing databases, market research data, and ad hoc data collection through registries and large simple studies. Dr. Stemhagen provides attendees with examples of metrics developed from ongoing programs, and outline strategies for selecting the most appropriate evaluation tools for the circumstances.

How to Evaluate Your RiskMAP was presented by Dr. Annette Stemhagen, VP Epidemiology & Risk Management, with United BioSource Corporation and aired on 2006-10-12. For more details or to purchase a download of this conference, please visit our site www.fxconferences.com