Industry Update Newsletters
Christina Hägglund, Quality Assurance Manager at S-cubed Ltd, issues a monthly summary of key updates and changes in international guidelines and regulations in the clinical research and drug development industry:
Websites and Links
The Association of the British Pharmaceutical Industry (ABPI)
European Medicines Agency (EMA)
Medicines & Healthcare products Regulatory Agency (MHRA)
National Research Ethics Service (NRES)
International Conference of Harmonisation Good Clinical Practice (ICH GCP) E6
Articles
OpenCDISC.org – an open source initiative delivering tools for validation of CDISC data
An article and presentation by Niel Both, Data Standardisation and Implementation Specialist at S-cubed ApS, prepared for the PhUSE 2010 Conference in Berlin, Germany
An article by Niel Both, Data Standardisation and Implementation Specialist at S-cubed ApS, written for the PhUSE 2009 Conference in Basel, Switzerland
Meeting CDISC Standards with SAS
An article by Scott McGregor, Managing Director of S-cubed ApS, in which he discusses the use of SAS software to implement CDISC standards