Leveraging Vendor Relationships to Achieve EDC Objectives

With all the choices and differences between electronic data capture (EDC) vendors and the claims that they make, it can be a daunting task to find one that meets your organization’s objectives. Many companies are using EDC as a replacement for paper, but they may not have a strategy or measurable objectives to ensure that organizational goals are benefiting from the introduction of this technology. By clarifying organizational goals and objectives, organizations can both target the best vendors and service providers, as well as tailor their request for information and pricing to simplify the selection process and quantify the decision.

In this conference, the speaker shares important strategies to help reduce cycle time, lower the cost of operations and improve data collection quality. Attendees discover techniques to effectively communicate their decisions and make the most of their vendor relationships.

Leveraging Vendor Relationships to Achieve EDC Objectives is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Wednesday, September 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

The $9 billion U.S. in vitro diagnostics (IVD) industry is ill prepared to meet the strict new regulations contained in the European Union's new IVD Directive. With only four business quarters left before the December 2003 deadline, IVD companies are realizing that translation is critical to earning the CE mark.

Manufacturers that lack effective plans for complying with the language requirements of the directive risk losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews present new challenges for the majority of diagnostics manufacturers who are dealing with non-English texts for the first time.

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements was presented by Andres Heuberger, President, with ForeignExchange Translations, Inc. and was previously recorded. For more details, or to download this conference please visit our site at www.fxconferences.com

Alternative Site Selection: China

This is one of two Covance audio conferences dealing with alternative site selection (the other event covers Latin America), and focuses on opportunities for the conduct of clinical research in China. This presentation provides an overview of the current clinical research environment in China and explores reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and is previously recorded. For more details or to download this conference, please visit our site at www.fxconferences.com

Optimizing Site Performance: Risk Planning vs. Remediation

A large percentage of clinical trial budgets is allocated to fix problems after they occur instead of proactive activities to predict and prevent errors. There are several factors causing the widespread variance in site performance in clinical trials, declining data quality and missed timelines. What can drug development service providers and sponsors do to proactively optimize site performance?

Protocol violations are a consequence of stressed environmental conditions at investigative sites and are extremely pervasive. Conventional measures won’t adequately detect or address them. This audio conference discusses and details how protocol violations are preventable within a risk management paradigm and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).

Optimizing Site Performance: Risk Planning vs. Remediation was presented by Pam Atwell, Director, Operational Strategies and Planning, with Covance Clinical Development Services and aired on 2008-12-04. For more details, or to download this audio conference, please visit our site at www.fxconferences.com

The New Rules for CME Sponsors and Providers

There are new rules governing commercial support of Continuing Medical Education (CME) programs which affect both CME providers and industry supporters, such as pharmaceutical, biotech and medical device companies. With Congress scrutinizing industry support of CME, the ACCME has issued new guidance, as well as a “Call for Comment” on the issue of industry funding. The new PhRMA Code (effective January 2009), along with independent state laws, has been adjusted to govern relationships between industry and physicians. Life sciences organizations, as well as CME providers, must keep abreast of these changes to maintain their accreditation status and ensure their internal policies are consistent with the latest laws and guidance.

This audio conference addresses how the new rules affect sponsors and providers and the best practices needed to comply.

The New Rules for CME Sponsors and Providers was presented by Maria D. Buckley, Nutter McClennen & Fish LLP and aired on 2009-01-08. For more details or to download this audio conference, please visit our site at www.fxconferences.com