In response to the high demand for key information and best practices for working with clinical oversight groups, ExL proudly presents the Clinical Oversight Groups conference to take place on October 14-15, 2009 in Loews, Philadelphia, Pennsylvania. Sponsors now have the opportunity to learn from industry professionals on how to improve trial managements and decision making through successful interactions with oversight groups.

This groundbreaking event provides clinical trial sponsors with practical information about the purpose, role and responsibilities of each of these types of oversight groups. The overall objectives of the conference are to: Establish parameters for the use of oversight groups, so that sponsors have a clear understanding of when each type of oversight group is needed for a clinical study.

Provide practical guidance on how to develop appropriate guidelines for oversight group implementation, so that sponsors are familiar with best practice for oversight group compilation, workflow, dataflow, data capture and data analysis.

Present effective models for use of multiple oversight groups on a single trial, so that sponsors gain insight into the relationships between their CECs, DMCs and Steering Committees. This aspect of the conference will address the areas in which oversight group communications and data exchanges most often intersect. It will also cover the areas in which appropriate boundaries and firewalls must be established between oversight groups.

Address best practices to support effective interactions between sponsors and their oversight groups, so that appropriate communications and data exchanges transpire, yet the independent nature of the oversight groups is preserved. Background:

Clinical oversight groups are an important part of a sponsor's management strategy for multiple aspects of a wide number of clinical studies. Implementation of expert oversight groups, whose members are independent of the trial sponsor, ensures an objective review of trial data for a number of purposes. Clinical Endpoint Committees (CECs) review and adjudicate study endpoints and provide standardized results which are utilized for statistical analyses of efficacy and safety outcomes. Data Monitoring Committees (DMCs) conduct periodic review of accumulating trial data to monitor patient safety and continually evaluate the emerging Benefit-Risk balance data that is produced as a result of protocol implementation. Steering Committees collaborate with the sponsor across the continuum of trial management, from protocol development to oversight of trial conduct to interpretation of study results. Clinical oversight groups bring value by helping sponsors design and conduct trials that are ethical and that produce valid and credible results.

Having full knowledge and understanding of CEC, DMC and Steering Committee processes enables sponsors to successfully implement oversight groups in appropriate settings, resulting in sound and effective decision making for on-going clinical projects.

Conference Sponsors:

The event is sponsored by Axio and Quintiles, and supported by the Society for Clinical Data Management (SCDM) and the Association of Clinical Research Professionals (ACRP).

Additional Information:

The Clinical Oversight Groups' complete program is available for review here.

For registration information, visit the conference website or email: registerexlpharma. Please reference priority code P434PR when registering or inquiring about the event.

Take advantage of the special group discounts. Register three people and receive 15% off of each registration. Register four people and receive 25% off of each registration. Please note that all three must register at the same time.

About ExL Pharma:

ExL Pharma is a leader in developing innovative, educational events that serve the healthcare community and allied professionals. Behind a diverse conference portfolio, an experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality conference events designed to exceed the dynamic informational needs of the healthcare community.

Source:
Jasmaine John
Marketing Director 
ExL Pharma 

555 8th Avenue, Suite.310

New York, NY 10018