[NMusers] RE: R for regulatory use

From: Penland, Chris <Chris.Penland_at_astrazeneca.com>
Date: Fri, 23 Mar 2018 16:31:06 +0000

Dear Ed

Thank you to Mango for contributing in this way - Can you share which were =
the 5 packages identified and the time from your notification to bug fix, n=
ew release?

Best,
Chris


Chris Penland, PhD
Director, Quantitative Clinical Pharmacology
Early Clinical Development, IMED Biotech Unit
Waltham, MA USA



From: owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com] On=
 Behalf Of Edward Gash
Sent: Friday, March 23, 2018 12:20 PM
To: Faelens, Ruben (Belgium) <Ruben.Faelens_at_sgs.com>; Christina Halliday <c=
halliday_at_mango-solutions.com>; nmusers_at_globomaxnm.com
Subject: [NMusers] RE: R for regulatory use

Hi Rubens,

Thanks for your questions, I'm always happy to have an open discussion abou=
t ValidR.

Yes the R Foundation has released information to support the use of R for r=
egulatory work. But this only covers the Core & Recommended packages that c=
ome with a basic installation. The 12,000+ packages that are available from=
 CRAN, BioConductor, R-Forge, Git or any other sources aren't covered.

Last year Mango carried out some analysis on the percentage of packages on =
CRAN that had a formal test framework. The results showed that less than 22=
% of packages had a formal test framework. As you're probably already aware=
, to register a package on CRAN there are some checks required, but these d=
on't necessarily relate to the functions contained in a particular package.

In terms of the testing that Mango carries out as part of our validation, i=
n the 3.2.5 release of R we validated 400 packages for our customers. Out o=
f those packages we found Critical Bugs in 5 packages which meant they fail=
ed validation and should not be used. Some of these were very well know pac=
kages and bug reports were sent to the package maintainers and fixes have b=
een made to newer versions of these packages.

Mango has consulted the R Foundation and the FDA as part of our product dev=
elopment. In addition to this Mango is also a founding member of the R Cons=
ortium which works with and supports the R Foundation in promoting the grow=
th and development of R as a leading platform for data science and statisti=
cal computing.

I hope this gives you some of the answers or further understanding that you=
 were looking for, but I'll be happy to talk more about the history, proces=
s and examples of customers using ValidR. Alternatively, please join us on =
the webinar on the 19th of April and I'll talk about this a lot more then a=
s well.


Kind regards,

Ed Gash
Mango Solutions

From: owner-nmusers_at_globomaxnm.com<mailto:owner-nmusers_at_globomaxnm.com> [ma=
ilto:owner-nmusers_at_globomaxnm.com] On Behalf Of Faelens, Ruben (Belgium)
Sent: 23 March 2018 15:36
To: Christina Halliday; nmusers_at_globomaxnm.com<mailto:nmusers_at_globomaxnm.co=
m>
Subject: [NMusers] RE: R for regulatory use

Dear Christina,

I would love to learn a bit more about this, and an open discussion on this=
 list is probably the best way.

Could you elaborate how specifically the open source nature of R causes con=
cern?
See the nice documentation from the R project core team at https://www.r-pr=
oject.org/doc/R-FDA.pdf
It seems to me that solid controls are in place, and the self-evaluation of=
 21 CFR part 11 by the R Core team does not result in any cause for concern=
. Perhaps I misinterpret or am too optimistic: Which parts of this self-eva=
luation document would you consider insufficient, or cause for concern?

Also see https://www.r-bloggers.com/r-drug-development-and-the-fda/, https:=
//www.r-bloggers.com/fda-r-ok-for-drug-trials/, and especially presentation=
s/posters from people at FDA: http://user2007.org/program/presentations/sou=
kup.pdf and http://blog.revolutionanalytics.com/downloads/FDA-Janice-Brodsk=
y-UseR-2012.pdf
I am quite allergic to people sowing fear, uncertainty and doubt on open-so=
urce software, especially when commercial off-the-shelf software is held to=
 different standards.

Best regards,
Ruben Faelens

From: owner-nmusers_at_globomaxnm.com<mailto:owner-nmusers_at_globomaxnm.com> [ma=
ilto:owner-nmusers_at_globomaxnm.com] On Behalf Of Christina Halliday
Sent: vrijdag 23 maart 2018 15:32
To: nmusers_at_globomaxnm.com<mailto:nmusers_at_globomaxnm.com>
Subject: [NMusers] R for regulatory use

Hi Everyone
As we know R has become the programming language of choice in many industri=
es due to its cutting edge capabilities.
However, R's open source nature can cause concern for heavily regulated ind=
ustries and companies that have strict policies around open source usage.
To overcome these concerns, Mango developed "ValidR". Mango's dedicated Val=
idation team have been supporting ValidR customers for a number of years.
ValidR delivers a controlled and validated version of open source R in line=
 with regulatory guidelines such as FDA 21 CFR part 11.

To find out more about ValidR, join our 30-minute free public webinar on Th=
ursday 19 April.
Register for your place here:

https://www.mango-solutions.com/validr/

Any questions please feel free to contact us at pharma_at_mango-solutions.com<=
mailto:pharma_at_mango-solutions.com>


Kind regards
Christina


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Received on Fri Mar 23 2018 - 12:31:06 EDT

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