Mr. Thierry Lambert will speak during Session 7 “STDM” (9:00 – 10:30). You can find the abstract of his presentation here : “Can Clinical Data Survive the CDISC Submission Standards?” Also, the conference program is now available for download on the CDISC website.

You can check the program here.

On April 19 2012, Mr. Thierry Lambert, Ph.D., will be speaking at the next CDISC International Interchange Conference in Stockholm.

In his presentation, Mr. Thierry Lambert will discuss some of the issues related to the SDTM/ADaM standards now required by the FDA for clinical data submission.

Here is an abstract of this presentation: we are looking forward to meeting you in Stockholm!

Can Clinical Data Survive the CDISC Submission Standards?

During a long experience of conversion of legacy clinical databases to build global analyzable databases, we have been receiving data in a wide variety of structures. For some years, this data is more and more in said “CDISC format” (SDTM/ADaM). Now this evolution has often lead to clinical databases of lesser quality.

In this presentation, we analyze the reasons for this degradation, and outline the conditions for a correct structuring and documentation of clinical data, in order to protect it from obsolescence, and allow building complete and easily workable data repositories.

We discuss the SDTM and ADaM models versus these requirements, and propose a certain number of trails (at short and longer term) allowing to simultaneously answer the legitimate needs of regulatory authorities, increase the quality of clinical databases, and even increase the productivity of clinical data processing.

AdClin Table Production Framework™

Version 3.2.2

New feature

• FilterGroupVar=NoMain (experimental) in Table2 (removes GroupVar lines that have no MainVar line)

Bug fixes

• Table1 & Table2: multilabel formats are now detected, only the primary label is retained
• Table1 & Table2: incorrect detection of range on numeric formats fixed
• Table1: warning in log when ByInBlocks=No, MainLines=Left, and 1st block has no printed data

AdClin Report Builder™

Version 3.2.10

Enhancements

• support for Office 2010

Bug fixes

• runtime error 4605 ‘The command is not available’ when re-inserting a renumbered table
• incorrect message “MS Word pretends that the highlighted row is too high to fit on a page.”
• Table object deleted during pagination in Word 2007 when footnote has a lot of lines

AdClin Navigator™

Version 2.5.19

Enhancements

• added installer support for Office 2007/2010
• added the possibility to operate Navigator import in batch (internal AdClin use)

Bug fixes

• error message in NavExport when the library contains no format
• formats > 8 chars not recognized in SAS v9

For more information about these two standards, please visit the CDISC® website:

• SDTM: http://www.cdisc.org/sdtm
• ADaM: http://www.cdisc.org/adam

The conference will be held at sanofi-aventis (Chilly-Mazarin, 2:30 PM to 3:30 PM).

We are looking forward to meeting you there!

May this year be your best one yet!

You will be able to directly review your database, instantly create graphs and tables over the data standardized by AdClin to a new corporate format (e.g. CDISC® SDTM/ADaM).

Please follow this link to download the leaflet (French).

So please check our Software Trial page to test our software right now!

During a year and a half, OSEO has been supporting the development of Discover, granting up to 30% of the development costs, including research, programming and marketing activities. With the upcoming release of the first version next fall, the contract established between AdClin and OSEO has come to an end.

This is the third successful collaboration of AdClin and OSEO and the second related to software development. The AdClin Normalizer™, used to quickly and securely transform clinical data to new standards (like CDISC), has also been supported by OSEO.