Overview
Research and Development and Regulatory Operations professionals both face substantial challenges in managing large amounts of information through complex processes. For example, the process of conducting clinical trials involves coordinating a large number of participants – including vendors, investigators, site monitors and regulatory staff — in a sophisticated, highly regulated set of processes. And Regulatory professionals face a similar challenge in assembling and organizing all the documentation associated with regulatory submissions.
In both cases, the traditional approach to automation in these areas has been to incorporate disparate tools into the process, an approach which actually increases complexity and cost. Users have to be trained in each system, and documents have to be moved between non-integrated systems.
The NextDocs Regulatory and Clinical Document Management Solutions, built on SharePoint, take a different approach. Leveraging SharePoint’s comfortable user interface and seamless integration with Microsoft Office, the NextDocs solution provides a familiar environment for all users, whether they are at remote study sites or at corporate headquarters. The solution connects the clinical and regulatory processes, and allows for easy integration with leading eCTD publishing solutions from companies like ISI, Liquent, Extedo and others.
During this session we will look at how the use of NextDocs and SharePoint can deliver compliance and collaboration without complexity and high cost. You’ll hear from Microsoft, NextDocs and professional services companies about their experiences implementing regulatory and clinical solutions, and you will leave with an appreciation for how the SharePoint-based NextDocs solution delivers improvements in both the regulatory and clinical domains.
Agenda
8:30-9:00 Registration and Breakfast
9:00 – 9:15 Microsoft in Life Sciences
9:15 – 9:45 Compliance without Complexity:
The NextDocs Approach to Regulatory and Clinical Automation
9:45 – 10:00 Break
10:00 – 11:15 Demonstration of the NextDocs Regulatory and Clinical Solutions
11:15 – 12:00 Implementing Regulatory and Clinical Solutions: Best Practices
12:00-1:00 Complimentary Lunch
Registration Information
January 13, 2009 – Islin, NJ
January 15, 2009 – Malvern, PA
January 29, 2009 – Mountain View, CA
January 30, 2009 – San Diego, CA
