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

Data Management for Medical Device Trials: Best Practices

There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation covers the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.

There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.

Data Management for Medical Device Trials: Best Practices was presented by Helen Colquhoun, MD, CEO, of Pleiad Devices and aired on 2007-11-01. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.

In this audio conference we will discuss the key items of an evidence-based approach to feasibility and ultimately, site and country selection.

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines is being presented by Kent Thoelke, Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs, with PRA International and airs on Wednesday, March 25, 2009. For more details or to register, please visit our site www.fxconferences.com

Protecting Data Under Current EU Pharma Legslation

European pharma legislation has seen several major changes come into effect over the past several years. Amongst others, the data protection rules have changed substantially. The data protection period for new approvals is now 8+2+1 years. The orphan protection, a full market exclusivity period, is 10+2 years. And the very recently introduced legislation on paediatric drugs (PUMA and PIP) plays an important role as well. The concept of the "Global Marketing Authorisation" needs consideration for the planning of the effective data protection period.

This presentation helps attendees understand current EU data protection rules and how best to operate within the regulatory framework.

This event is presented by Ulrich Granzer, owner of Granzer Regulatory Consulting & Services. To learn more, please visit www.fxconferences.com.

Data Management for Medical Device Trials: Best Practices

There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation will cover the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.

There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.

This audio conference is presented Helen Colquhoun, MD, CEO of Pleiad Devices. For more information of Data Management for Medical Device Trials: Best Practices, please visit our site www.fxconferences.com