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Meeting on Data Issues Related to the Common Technical Document

This 2-day meeting will address data management and statistical issues related to filing an NDA in Common Technical Document (CTD) format.  Data management issues will be discussed related to preparing study data bases and data sets needed to support the integrated analysis of efficacy (IAE) and the integrated analysis of safety (IAS).  Statistical issues will be discussed related to preparing the analysis plans for the IAE and IAS and reporting the results of these integrated analyses.

CALL FOR PAPERS:  If you are interested in presenting at this meeting, send an e-mail with your name, your title, your organization, and your topic.  Respond by 15 July 2003.

This meeting will be held in Orlando Florida in November.  Details will be forthcoming.

TRAINING:  In-house training is available on the following topics:
How to Write a Report Compliant with ICH E3
How to Write a Statistical Analysis Plan Compliant with ICH E9
Data Management in Clinical Trials
Auditing of Data Bases
Auditing of Study Reports and other Documents

 

 

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