similar to: 21 CFR Part 11 Compliance and R

I hope that Marc doesn't mind, but I felt that part of his recent post was important enough to deserve it's own subject line rather then being lost in a 60-msg-long thread... On Sun, Jan 11, 2009 at 10:08 AM, Marc Schwartz <marc_schwartz at comcast.net> wrote: ... I strongly believe that the comments regarding R and the FDA are overly negative and pessimistic. The hurdles to

Dear All, discussing with a statistician of a pharmaceutical company I received this answer about the statistical package that I have planned to use: As R is not a validated software package, we would like to ask if it would rather be possible for you to use SAS, SPSS or another approved statistical software system. Could someone suggest me a 'polite' answer? TIA Giovanni -- dr.

Does anybody know if R is FDA or ICH (or EMEA...) compliant? AFAIK S-Plus is but that means nothing... -- Trebate bolji pristup internetu? Nazovite IskonInternet na 0800 1000 ili pogledajte http://www.iskon.biz/individualni/usluge/dialup/

I would like to use R for submissions to FDA/CDRH (the medical device company I work for currently uses only SAS). Previous postings to the list regarding R and 21 CFR 11 compliance have been very helpful. However, reluctance to using open source software for statistical analyses and reporting remains high here at my company. Has anyone used R for an official submission to FDA/CDRH? It would

As I work as a biostatistician in the medical devices industry, I have been very happy to take part in several conversations on this list regarding the use of R in a regulated environment. It was with great interest, therefore, that I read the new guidance document for the use of R in regulated clinical trial environments now available on the R website. The purpose of the document is

Hi All I am really very interested in starting to use R within our company. I particularly like the open source nature of the product. My company is a medical research company which is part of the University of London. We conduct contract virology research for large pharma companies. My question is how do we validate this software? I wonder if anyone else has had the problem and might be able to

Dear all, There have been a variety of discussions on the R list regarding the use of R in clinical trials. The following post from the STATA list provides an interesting opinion regarding why SAS remains so popular in this arena: http://www.stata.com/statalist/archive/2008-01/msg00098.html Regards, -Cody Hamilton

Hi all there Can some one clarify me on this issue, features wise which is better R or SAS, leaving the commerical aspect associated with it. I suppose there are few people who have worked on both R and SAS and wish they would be able to help me in deciding on this. THank you for the help --------------------------------- [[alternative HTML version deleted]]

Hello Everyone,   I’m a SAS user who has recently become interested in sequential clinical trials designs. I’ve discovered that the SAS based approaches for these designs are either too costly or are “experimental.” So now I’m looking for alternative software. Two programs that seem promising are SPLUS Seqtrial and R.   I recently obtained a 30 day trial for the SPLUS Seqtrial add-on and have

I like R more than SAS. My job is doing research on clinical trial. But I was told that FDA only accepts the result from SAS. Is that true? TOO BAD. [[alternate HTML version deleted]]

Hello! I'm working on a new back-end and have hit a bit of a snag. I'm working on getting selectcc working and have followed the MSP430 model of emitting a custom CMP and SELECT_CC node and matching that with a pseudo-instruction that has useCustomEmitter=1. However, my output ends up very wrong, despite the Machine code being initially correct: # Machine code for function func: Function

But in the first version it's used on the next row: %reg16388<def> = CMPrr %reg16384, %reg16385, %CFR<imp-def,dead>; IntRegs:%reg16388,16384,16385 SKIPCOND 1, *%CFR<imp-use>* Or doesn't that count? Following are patters for cmp and skipcond: def cmpcc : SDNode<"CSISD::CMP", SDTIntBinOp, [SDNPOutFlag]>; let Defs = [CFR] in { def CMPrr :

Hello Per, > The CMPrr instruction is moved down to after the PHI node. My guess is that > the 'dead' in CFR<imp-def,dead> is to blame, but I can't see what I'm doing > differently from MSP430/sparc that makes this not work. Any help GREATLY > appreciated! It seems like no use of CFR after CMP, indeed. How condbranches on your platform look like (patterns, etc.)

I did a make update. I thought I was running the newest version of compiler-rt. But now I can't even get the project to build. I get the following error: i386-redhat-linux-gnu-clang++: clang/llvm/include/llvm/ADT/SmallVector.h:544: typename llvm::SmallVectorTemplateBase<T, llvm::isPodLike::value>::iterator llvm::SmallVectorImpl<T>::insert(typename

+kcc, llvmdev I think your compiler-rt checkout is out of date, because r188635 is supposed to fix that exact issue. On Mon, Aug 19, 2013 at 9:16 PM, Sharma, Yogesh < Yogesh.Sharma at saabsensis.com> wrote: > Sorry about that. I forgot a d:**** > > ** ** > > ldd (GNU libc) 2.12**** > > Copyright (C) 2010 Free Software Foundation, Inc.**** > > This is free

GNU ld version 2.20.51.0.2-5.36.el6 20100205 Copyright 2009 Free Software Foundation, Inc. This program is free software; you may redistribute it under the terms of the GNU General Public License version 3 or (at your option) a later version. This program has absolutely no warranty. From: Kostya Serebryany [mailto:kcc at google.com] Sent: Monday, August 19, 2013 5:36 AM To: Sergey Matveev Cc:

Yesterday I just noticed the new document on R and regulatory aspects for biomedical research posted at http://www.r-project.org/doc/R-FDA.pdf Coming from an institution that performs a large number of clinical trials for FDA and being an advocate of R myself, I have found that the following issues usually come up when discussing the use of R for FDA trials: 1. Most FDA submissions come down to

It just occured to me that perhaps what happens is that since the cmp-instruction is initially followed by the pseudo-instruction - which doesn't have Uses = [CFR] - that it's marked dead initially, and never changed back when the SKIPCOND is inserted by the custom emitter? But I feel that this would happen in e.g. MSP430 too then... On Wed, Dec 15, 2010 at 10:14 AM, Anton Korobeynikov

Sorry if this is spam, but I couldn't see it having popped up on the list yet. http://www.nytimes.com/2009/01/07/technology/business-computing/07program.html?emc=eta1 Anand [[alternative HTML version deleted]]

+llvmdev (llvm-dev does not exist) On Mon, Aug 19, 2013 at 12:58 PM, Sergey Matveev <earthdok at google.com>wrote: > > First, could you please run the test with env.var. > ASAN_OPTIONS=verbosity=1 > > No need for that, actually, since this is a familiar issue. Sharma, could > you please paste the output of "ldd --version" here? > > Sergey > > >