spacer
home > epc > winter 2009 > meeting standards with sas
PUBLICATIONS
European Pharmaceutical Contractor

Meeting Standards with SAS

 

Today, it is commonplace to see the acronym CDISC projected onto pharmaceutical sector meeting room walls. The Clinical Data Interchange Standards Consortium has developed a set of standards that “support the acquisition, exchange, submission and archive of clinical research data and metadata”. This support was exactly what the industry needed and CDISC standards, with acronyms such as CDASH, SDTM and ADaM, and their implementation is something that most companies have high on their project priority list.

Although the standards themselves come for free, the implementation of them does not. Rather, substantial time and effort need to be invested before the real benefits can be seen. This initial investment can involve reallocation and training of resources, changing of internal standards, reengineering of processes and systems and, in most cases, some outsourcing to companies specialising in these standards. By using SAS software at key points in the data handling and reporting process, you can reduce the initial costs required to implement these standards and achieve their full benefits.

A LITTLE ABOUT CDISC STANDARDS

The most developed and widely implemented of the CDISC standards is the study data tabulation model (SDTM), partly because the FDA in the US recommends SDTM as the model for submission of raw clinical data. The model is not only useful for submission, but also serves as an excellent standard for the interchange of raw clinical data. Due to this, many companies have adopted SDTM as an internal standard for pre-analysis clinical data.

For statistical analysis data, CDISC provides the ADaM model. It supports the clear and unambiguous communication of statistical results, covering both the derived and statistical data as well as result metadata. The FDA does not yet recommend or require the submission of analysis data in CDISC ADaM format, however, due to the strong links between ADaM and SDTM, using them together for a submission increases transparency, which may make this the logical next step. Several companies have already started submitting analysis data in the ADaM format.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Scott McGregor is co-owner and SAS Solution Specialist at S-cubed. He began his career in the pharmaceutical industry as a SAS programmer in 1990 and worked with SAS in various sectors before founding Scubed in 2007. Through his work in the pharmaceutical industry, Scott is regularly involved in data onversion, reporting and submission projects and works closely with the implementation and use of CDISC standards.

spacer
Scott McGregor
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PPMA Group Industry Awards 2019

PPMA Group is today issuing a ‘Final Call for Entries’ to the 2019 PPMA Group Industry Awards. All companies within the packaging and processing sector are invited to submit their FREE submission by the deadline of 17 July 2019.
More info >>

White Papers

e-tools enhance clinical trial performance

e-novex

In today’s ever-evolving medical business, technological changes require innovation to meet growing market demands and to bring about advances in the industry. One such development currently taking place in the field of clinical research is how e-tools are initiating a boost in the productivity of clinical trials.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement