Outsourcing Strategy for Biostatistics and Data Management -- MBC Biostatistics and Data Management Committee Meeting

Outsourcing Strategy for Biostatistics and Data Management

You are invited to join the MBC Biostatistics and Data Management Committee for a presentation on
"Outsourcing Strategy for Biostatistics and Data Management"

When : Thursday, March 29, 2007

From : 12:00-2:00 PM

Where : MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA

Overview :
In an effort to contribute to the high quality education of the MBC membership, this session will help biotechnology companies understand how to develop an outsourcing strategy for selecting the most qualified and effective vendors for Biostatistics and Data Management projects.

Especially in the Boston area, there is no shortage of vendors who claim to have Biostatistics and/or Data Management expertise. This includes everything from huge CROs with thousands of scientific staff, to one- or two-person operations. Just like shopping for a new car, educated customers who've done their homework ahead of time are much more likely to select the vendor who will provide a successful outsourcing experience, thereby avoiding the missed endpoints, cost and time overruns of a "lemon" project.

This session will help users to understand the type of information they should provide and request from a vendor during the Request for Proposal process, as well as the kind of qualifications they should be looking for. The session will also discuss the types of projects that often benefit from outsourcing, and may provide new ideas for supporting your products using external Biostatistics and Data Management capabilities.

The program will include:

• How to write a Request for Proposal (RFP) that will get you what you need from your Data Management and Biostatistics vendor
• The TOP 10 questions you should ask your vendor
• What should you be looking for when you choose a vendor for your Biostatistics and Data Management work?
• What is the impact of using different vendors for conducting a clinical trial and doing the data management and statistical analysis?
• Should we be using Electronic Data Capture or paper CRFs?
• What is MedDRA and why do I need a license?
• What is WHO Drug and why do I need a license?

Speakers :
Kay Larholt Sc.D. Vice President and Executive Director, Biometrics and Clinical Operations, Abt Associates.

David Savukinas, Sr. Director Clinical Data Management, Biomedical Operations, Genzyme Corporation

Lunch will be served.
RSVP to register@massbio.org and please put BDM-3/29 in the subject line.