Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials

is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Thursday, October 14th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.

However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.

Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.

Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials

is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Tuesday, September 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.

However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.

Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.

Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development, the question arises as how to interpret the data.
The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range), and from this range, defining the probability of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approach embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation was presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, with Covance Central Laboratory Services and aired on 2009-01-28. For more details or to download this event, please visit our site at www.fxconferences.com

Contracts: Aligning Sponsor & CRO Interests

A primary objective for the outsourcing and procurement divisions of pharmaceutical and biotech companies is to select the best CRO to undertake their project and deliver it to success. A primary objective for the CRO is to deliver the project to success and earn repeat business with the Sponsor. Both parties' core objective is the same: to deliver the study to success. However, for both organizations it is essential that the business objectives are aligned and therefore, when entering into a Sponsor-CRO contractual arrangement, there are various elements of risk to be considered by both parties.

This presentation, the last in a three-part series on best practices for outsourcing, focuses on the components of managing both legal and financial risk through effective contracting.

Contracts: Aligning Sponsor & CRO Interests was presented by Lynn Polgar, Associate Director, US Contract Management Group, with Covance and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

Conducting Drug Trials in Central & Eastern Europe

Over the next several months, ForeignExchange will present a series of audio conferences featuring expert speakers from Covance discussing the key benefits and drawbacks of using non-traditional sites for conducting clinical research.

In this first first presentation, we focus on the opportunities present in Central and Eastern Europe. This presentation will highlight the current status of the health care system in this region, and how it creates a propitious environment for clinical research business development, boasting rapid recruitment and high quality data.

Conducting Drug Trials in Central & Eastern Europe was presented by Dr. Malgorzata Szerszeniewska, Director of Strategic Development, Central & Eastern Europe, with Covance and is previously recorded. To download this event, or for more details please visit our site at www.fxconferences.com

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit

Successfully implementing EDC depends on having processes in place that take advantage of the technology. Although it is generally possible to use EDC with processes that were designed for paper case report forms, there are many ways EDC can be integrated into the clinical trial process to make it more efficient, and depending on the goals for EDC, there are many metrics that can be captured to help establish benefits. Among these are cycle time for resolving queries, use of standards, quality of data, cost per form or datapoint, time between last patient visit and database lock.

This conference explores how processes related to EDC can be integrated into clinical trial processes for creating and deploying case report forms, as well as monitoring and managing trials. Our speaker shares insights on how to use lean concepts to look at the processes you have, identify opportunities for improvement and show measurable progress.

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Tuesday, November 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Outsourced Data Management: How to Align Performance Expectations

When it comes to clinical development outsourcing, it is not uncommon to see that data management has not been included in the process until it is well underway or nearly complete. Unfortunately, this tactical approach to data management outsourcing opens the door for performance expectations to diverge once the trial is underway, as initial expectations were never made transparent and fully aligned.

This session explores the challenges and strategies involved in successful data management outsourcing between sponsor companies and CROs. The speaker shares his insights and offers actionable, pragmatic approaches to consider, and reviews case studies which measure the impact of these approaches on a sponsor’s business success.

Outsourced Data Management: How to Align Performance Expectations is being presented by Mark Anderson, Senior Director, Clinical Data Management, with Covance and airs on Wednesday, October 28, 2009. For more details or to register, please visit our site at www.fxconferences.com

Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change

Effective management of project financials is absolutely integral to successful project management. It is essential to to establish a baseline budget, construct billing guides and calculate the Earned Value Analysis (EVA) with detailed projections of spend rates. In this session, the speaker discusses the change order process, including how to identify an out-of-scope item and/or scope creep, plus proactive approaches to manage your project financials.

This conference explores best practices on how to build a budget, analyze spend, proactively identify change orders and identify strategies to work within the budget. The speaker also reviews options for effectively controlling the budget.

Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change is being presented by Dr. Ann Flandermeyer, Senior Director, Project Management & Clinical Operations, with Covance and airs on Wednesday, October 14, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Effective Risk Management: The Cost of Prevention?

Managing the risk in clinical trials is a hot topic today, but how should it be done, how effective is it, and how do we demonstrate value for our investment?

This presentation outlines the current or transitional approach to risk management and where this could mislead. It moves on to consider the variability inherent within clinical trials and the importance of understanding this in risk management. The final section covers risk mitigation and some of the benefits which can accrue from employing an effective risk management strategy in clinical study delivery.

Effective Risk Management: The Cost of Prevention? was previously presented by Rob Davie, PhD, Vice President, Clinical Service Delivery & Clinical Development Services, Europe, with Covance. For more details or to download this conference, please visit our site at www.fxconferences.com

Site Activation: How to Get Beyond the Classic Pitfalls

Efficient site activation is critical to set the tone for a successful clinical trial. Given the number of activities that are involved during site activation, there are several challenges that are faced -- many of which are encountered time and time again. Therefore, knowing what these challenges are, being able to work through them and even being able to prevent them when possible, is imperative to timely site activation.

This session reviews the processes and reports currently utilized to manage site activation issues, as well as practical tools and lessons learned. The speaker shares firsthand experiences and explains how to implement best practices that address the classic challenges of this dynamic process, while avoiding the pitfalls.

Site Activation: How to Get Beyond the Classic Pitfalls is being presented by Heather Almonte, Senior Manager, Site Activation Services, with Covance and airs on Wednesday, September 23, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

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

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 RFPs: Simple Steps to Better Responses

Is your organization in the process of putting together an RFP? Have the responses to your past RFPs fallen short of expectations? CRO teams respond to hundreds of RFPs each year. It is clear which sponsors have invested time to build internal consensus and to develop a document that clearly articulates their needs and project goals. The result is a guide that assists the CRO in assembling a higher quality response that directly addresses the needs of the sponsor.

This audio conference is the first in a three-part series designed to share best practices for optimal outsourcing.

Optimizing RFPs: Simple Steps to Better Responses was presented by Beth Mandel, Director of Strategic Solutions, with Covance, and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

How to Select a CRO: Best Practices

The outsourcing and procurement divisions of pharmaceutical and biotech companies are charged with identifying and selecting external vendors most suited to assist them with delivering success for their organizations. Today, with the broad selection of companies available, offering a variety of services, a streamlined, straightforward selection process presents a challenge.

As a whole, the selection process represents a significant time investment from Sponsor organizations. One method for streamlining the selection process is to develop a set of standard criteria to evaluate and judge the respondents. However, the underlying complexity of the multiple variables involved raises questions as to the effectiveness of a standardized approach.

This audio conference is the second in a three-part series designed to share observations on best practices. This presentation discusses the components of CRO selection and will focus on comparing and contrasting a standardized approach versus customized approach.

How to Select a CRO: Best Practices was presented by Teresa Ptaszynska, BSc., PhD, Director, Proposal Development, with Covance and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Ensuring Compliance in Global Clinical Trials

An increasingly intense competitive environment and the shrinking pools of treatment populations in traditional markets has forced drug companies to ‘go global’ and approach emerging markets to place research and secure enrollment. But how do you ‘go global’ without sacrificing consistency and quality in clinical trials?

This audio conference discusses the unique challenges posed by international clinical trials, and provide a regulatory expert view of how to overcome these challenges and ensure compliance across various countries and geographic regions.

Ensuring Compliance in Global Clinical Trials was presented by Bruce Wagman, Vice President Regulatory & QA Services, with Covance, Inc. and aired on 2008-04-24. For more details or to download this conference, 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

Predicting and Preventing Protocol Violations

Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.

This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.

Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com

Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World

One of the provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is that the FDA requires manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug or biologic first comes on the market, or later if they become aware of new safety data about the drug. What risk signals should be looked for early in the development process?

In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated actvities that begin with early clinical testing are key, and must continue throughout the product lifecycle.

Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World is being presented by Dr. Edgar Adams & Robin Carter, Executive Director, Epidemiology & Senior Director, Risk Management Operations, with Covance, and airs on Tuesday, May 5, 2009. For more details or to register for 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

Risk Mitigation and Prevention in Real-Life Trials

Managing and preventing risk is an integral part of managing any clinical trial. This presentation showcases a series of real-life examples, and explore ways to leverage sophisticated tools and proactive approaches to managing project-related risk. Naturally, a flexible approach customized to each individual case is required, and this presentation shows how to go about it.

Acknowledging the need for continuous mitigation of project related risks, the speaker also explains and demonstrates methods for overcoming challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.

Risk Mitigation and Prevention in Real-Life Trials was presented by Jill Johnston, Senior Director, Project Management & Clinical Ops, with Covance and aired on 2007-04-05. For more details, or to purchase a recording, please visit our site www.fxconferences.com