Meetings, Training, and Seminars
Meeting on Data Issues Related to the Common Technical
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.
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 is available on the following topics:
How to Write a Report
Compliant with ICH E3
How to Write a Statistical Analysis Plan Compliant with
Data Management in Clinical Trials
Auditing of Data
Auditing of Study Reports and other Documents
Consulting Services | Data Management | Medical Writing | Auditing | Programming
Statistics | Due-Diligence | Seminars | Employment | Contact Us | Home | Admin