Preparing an eSubmission based on multiple trials, some of which are ongoing — challenges for statistical programming

Author: Carlsheimer, Åsa

Source: Pharmaceutical Programming, Volume 4, Numbers 1-2, December 2011 , pp. 114-118(5)

Publisher: Maney Publishing

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Abstract:

Preparing for an eSubmission based on multiple trials, some of which are ongoing, is a challenging task for statistical programmers. Having Analysis Data Model (ADaM) standards in place and maintaining a pooled data repository will facilitate the submission work on the data side. However, generating more than 1100 tables and figures for the Integrated Summary of Safety and Efficacy, involving a large team of biostatisticians and statistical programmers (in-house and off-shore), requires careful planning that includes preliminary discussions on consistency across programs. The purpose of this paper is to share experiences and provide some advice for statistical programmers to consider in future submission work.

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Keywords: STANDARD; REPOSITORY; ESUBMISSION; VALIDATION; ISS/ISE

Document Type: Research Article

DOI: http://dx.doi.org/10.1179/175709311X13141790413200

Affiliations: Ferring Pharmaceuticals, Copenhagen, Denmark

Publication date: 2011-12-01

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