Webcast:

Register Now!

The FDA is highly encouraging that all pharmaceutical/biotech sponsors adhere to the CDISC SDTM dataset standards for all new NDA Submissions to the agency. For most firms, this means that sponsors will need to convert all legacy studies to the CDISC SDTM standards for datasets to be submitted as part of their New Drug application to the agency, and to ensure that all future studies address this requirement from a proactive perspective.

So what does this mean to sponsors?
What aspects of these requirements should sponsors consider performing in-house (internally)?
What aspects of these requirements should sponsors consider outsourcing?
Are there specific components that lend themselves more readily to performing these conversions internally and/or externally?
What is the amount of effort and time required for each strategy?
What about ADaM?

TAKE Solutions invites you to attend a seminar on the different aspects of addressing this issue One aspect is from a prospective approach to CDISC SDTM standards (data collection – what to in-source and what to outsource). The other aspect is from a legacy studies perspective for future submissions or data warehousing purposes. TAKE brings to you three experienced speakers for this event who will provide a 360 degree perspective (vendors & sponsors) on these new recommendations from the FDA.

AGENDA
2:00 - 3:00pm     Seminar on prospective approach to CDISC standards from data collection. What to in-source and what to outsource?
3:00 - 3:30pm     Q & A – Discussion Panel
3:30 - 4:30pm     Seminar on legacy studies and data warehousing purposes. What to in-source and what to outsource?
4:30 - 5:00pm     Q & A – Discussion Panel
5:00 – 6:00pm    Networking/Cocktail Hour

Register now to know more about the efforts required to perform the conversion activities and e-submission activities including Define.xml.

CDISC SDTM dataset conversions for NDA submissions to the FDA - In-house or Outsource?

Seminar Location:
Speaker:
Preferred Appointment Date:
Work Email Address:
First Name:
Last Name:
Company Name:
Phone Number:
Country:
Lead Source:

Please select the city in which you would prefer to attend the seminar.

Please select a speaker and date if you would like to set up a session post seminar.

The key take away for the attendees:

Various approaches to prospective standardization and metrics around the activities involved
Decision making on when to start the CDISC compliant submission data preparation including SDTM & ADaM - based on TAKE’s past experiences.
Adoption of data standards moving forward when the CDISC implementation guide is still evolving
Investment required to perform the ongoing and legacy studies

Seminar Details

Date & Time:
June 15, 2011 - San Francisco
2:00 p.m. - 6:00 p.m.

DoubleTree by Hilton
San Francisco Airport
835 Airport Blvd., Burlingame,
CA 94010-9949

June 16, 2011 - San Diego
2:00 p.m. - 6:00 p.m.

Hyatt Regency La Jolla
3777 La Jolla Village Drive
San Diego, CA 92122

Presenters:
Ilango Ramanujam
Practice Head- Clinical, Regulatory & Safety Services
TAKE Solutions Inc.

Dr. Samuel Givens
(PhD Biostatistics)
Statistical Consultant

Mark Williams
Vice President / CIO
Applied Clinical Intelligence

<!--[if gte mso 10]>

Anthony Aming
Supplier e-Procurement Manager, Enterprise Applications
Baker Hughes