[R] R validation

[delphine.fontaine at genexion.com]

Dear R-Users,

A message to continue the discussions we had in March and June. I have
read the documents written since then
(http://www.r-project.org/doc/R-FDA.pdf ;
http://user2007.org/program/presentations/harrell.pdf ;
http://user2007.org/program/presentations/rossini.pdf ;
http://user2007.org/program/presentations/soukup.pdf) which are very
interesting and useful.

I work in a CRO and we strongly believe that R could be our standard
statistical tool for all our analyses. I agree that it is more relevant
(and easier) to validate an analysis than the whole software but anyway,
if we want to systematically use R, we must convince our top management
first and then our clients that R is reliable. Most of them do not know
the R environment and it is more that likely that we will be asked for any
validation documentation.

I am sure that the Core team has thoroughly tested “Base R” functions and
the recommended packages. Is it possible to have access to the scripts or
any documents that would attest that R gives reliable/validated results ?
All the discussions, documents mentioned above are a big step for the use
of R in the pharma/biotech environment but I also think that validation
documents or scripts are indispensable to convince our top management, our
clients and regulatory bodies.

If validation documentation or scripts do not exist or are not available,
could anyone tell me in concrete terms which are the minimum requirements
to validate R functions or packages ?

Thanks !

Delphine Fontaine

Delphine Fontaine
Statistician
Data & Statistics Department - Genexion SA
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29, Quai du Mont-Blanc
Geneva, CH-1201
Switzerland
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Office: +41 22 704 32 44
Fax:    +41 22 704 32 42
Email: Delphine.Fontaine at genexion.com