Clinical Research

Clinical Research Archived Events

Deploying Microsoft SharePoint-based Clinical Portals for Investigator Site Management: Technical Deep Dive

Speaker: Daniel O’Connor, co-founder, Innovocommerce LLC
Date: Jan. 20, 2010

Description: This presentation by Daniel O’Connor, co-Founder of InnovoCommerce LLC will introduce innovative, in depth technical approaches to using Microsoft SharePoint to launch, organize and manage clinical trial investigator sites in compliance with FDA rules and regulations.

• Learn how you can deploy a SharePoint-based clinical portal solution to manage investigator sites document exchange
• Understand how SharePoint capabilities, features and enhancements can enable advanced management of clinical trial investigator site management
• Better understand some potential pitfalls and issues when considering the deployment of a SharePoint-based clinical portal
• Learn how to start thinking about validating SharePoint clinical portal

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Do’s and Don’ts of Clinical Trials in Africa — The Regulatory, Ethical, and Operational Challenges

Speaker: Francis P. Crawley, Good Clinical Practice Alliance – Europe
Date: March 31, 2009

Description: This teleconference by Francis P. Crawley, Good Clinical Practice Alliance – Europe (GCPA), Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), examines the current environment for carrying out clinical trials in Africa. While Africa has long suffered from political and economic instabilities and weaknesses, the continent is increasingly becoming involved in clinical trials, both with regard to data for use in global product development and marketing authorization, but also in terms of meeting specific African and developing countries’ health needs. In recent years there has been a development of the pharmaceutical industry in Africa primarily through the growth of the CRO industry as well as through cooperation between industry and international and national health research funding organizations.

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The Revised Declaration of Helsinki: A Critical Appreciation

Speaker: Francis P. Crawley, Good Clinical Practice Alliance – Europe
Date: Jan. 8. 2009

Description: Following on the presentation of the background and key changes to the 2008 revision of the Declaration of Helsinki, this briefing examines questions that arise in putting Helsinki into practice within the framework of the current international discussion on research ethics in clinical trials.

It examines the debates arising out of Helsinki on the use of control arms (including the use of placebo), post-study obligations on the part of researchers and sponsors, obligations to individuals and communities/populations, clinical trial registration and reporting results, vulnerable populations, and the role of IRBs/ethics committees.

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What You Must Know About the Expanded Clinical Trial Registry and the New Clinical Trial Results Database

Speaker: Sheldon Bradshaw, Partner and Co-Chair, FDA Practice Group, Hunton & Williams, LLP, Formerly Chief Counsel, FDA
Date: Nov. 12, 2008

Description: eturning for his third Expertbriefing, former FDA Chief Counsel Sheldon Bradshaw will discuss everything you need to know about the Expanded Clinical Trial Registry and the New Clinical Trial Results Database to continue to operate your trials in a cost-effective manner. The registry and database were established last year as part of Title VIII of the Food and Drug Administration Amendments Act (FDAAA), which expanded the existing NIH clinical trial registry and created a clinical trial results databank.

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