Compliance issues in clinical research

[deleted_user]

Hi,

I work for a small CRO which is trying to get information on what is required to assure compliance with CFR Part 11. In our contact with SAS they tried to sell us their Drug Development tool which was rejected by management as too expensive.

Can anyone shed light as to what other options are available and how the regulations can be translated into real world system requirements? Any help would be appreciated.

Thanks,

Bob

[Doc_Duke]

SAS provides a validation suite of programs to run after installing SAS and that is the first step to compliance.

There are two books that will give you a good start on this process.

"SAS Programming in the Pharmaceutical Industry" by Jack Shostak
and
"Validating Clinical Trial Data Reporting with SAS" by Carol I. Matthews and Brian Shilling

Both are available on the SAS Publications web pages.

Doc