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.

Improving Patient Recruitment Through Better CRA Training

The clinical trial industry's single greatest challenge continues to be timely patient recruitment and retention. One major obstacle is trial drift -- the gradual reduction in study knowledge as a clinical trial ages, resulting largely from inadequate staff training about the protocol and good clinical practices (GCP). The problem is further compounded by high turnover among site staff, with industry data suggesting an average CRA tenure of only 18 months to 2 years -- shorter than many studies.

At the same time, regulatory agencies are increasingly demanding proof that global clinical study staff are appropriately trained and assessed in a standardized manner and, depending on the therapeutic area, that ongoing "recalibrations" in staff education and training are performed during the term of a study in order to minimize trial drift. What's more, there is a growing movement in the industry to require site managers and CRAs to earn GCP certification, further underscoring why effective training is a business imperative.

This presentation focuses on how a well-planned, consistent training program can help sponsors and CROs meet or even exceed enrollment deadlines, and thereby speed drug development.

Improving Patient Recruitment Through Better CRA Training was presented by Linda Wolf, with BBK Worldwide Alliance and aired on 2008-05-22. For more details, or to download this conference please visit our site at 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