application that pharma companies deal with - FDA 21 CFR Part 11-
regulated and non-. Non-regulated apps would include the websites
described below, and in fact, outsourcing them is a good way to make
sure they don't become regulated.
Regulated apps are anything that even vaguely brushes up against
patient data. The FDA rule, at it's core, basically says that you as
a pharma have to be able to prove that any digital records pertaining
to patient or pharmaceutical trial data have to be as secure and
guaranteed as writing them down on paper and locking them up.
In practice, this means you need a ton of controls and predictability
around everything, all things cloud computing is not always built to
provide. For example, let's say I wanted to store a file with trial
parameters on a cloud storage platform. I'd need to have some way to
checksum that file to insure no modifications, and I need some way to
externally store that checksum for years, and that's just one tech
piece. It's not enough to just look at the file size, say.
So, pharma can use the cloud, but for their core business functions,
they are unlikely to use anything other than a dedicated pharma cloud,
if at all.
Matt
On Dec 22, 2008, at 10:20 PM, "Sankar Nagarajan" <nagarajansankar@gmail.com
> wrote:
>
> I was involved with a project for a fairly large Pharma company which
> had about 233 websites that it maintained for its numerous consumer
> product lines.
>
> It acquired another consumer Pharma company that brought in another
> 100+ product websites in.... There were then a dozen variants to these
> websites to cater to internationalisation - customers /partners across
> the world
>
> The websites were hosted with a dozen vendors and its management was
> outsourced . It was so unorganised and the company was burning a lot
> of money in maintaining them. Then there was an integration and
> consolidation effort looking for an integrated scalable Content
> management and web solution at a lower TCO.
> Then they started looking for Global delivery/offshore vendors like us
> to help reduce the TCO............
>
> Business Applications such as this for large Pharma firms are better
> amenable to be moved to CC and Cloud based Content Management (CMS)
> solutions that can dynamically scale and serve content globally may
> find new opportunities..Increased usage of CC at a lower cost /TCO
> perhaps means less Global IT outsourcing from the US ! -;) (which is
> good)
>
> -Sankar
>
> On Dec 23, 2:57 am, "John Brothers" <joh...@gmail.com> wrote:
>> Yeah, I've done a fair amount of software dev for both the clinical
>> trial
>> management side of Pharma as well as Sales and Marketing. I don't
>> see any
>> obvious wins for CC in the Sales and Marketing, but then if they were
>> obvious, people would be doing them already :)
>>
>> On the Trial Management side... it seems like there's more
>> potential for CC
>> in trial management, but I struggle with what that might look
>> like. They
>> generally are never CPU-bound. In other words, there's still a
>> lot of
>> potential for plain old regular software development improvements
>> to their
>> processes and systems, before we even consider CC.
>>
>> As web applications for CTM proliferate, I could see the use of
>> clouds to
>> manage demand and ease deployment, but that's hardly a killer app.
>>
>> john
>>
>> On Mon, Dec 22, 2008 at 3:16 PM, Jan Klincewicz
>> <jan.klincew...@gmail.com>wrote:
>>
>>
>>
>>
>>
>>> It actually gets a little more complicated than that. Pharma
>>> typically
>>> consists of Drug Discovery (the Science part) as well as typical
>>> Front
>>> Office (Corporate, Regulatory, Marketing/Sales etc.) They have
>>> totally
>>> different needs and agendas. I have found the Science side to
>>> usually be
>>> somewhat autonomous and cutting edge, adopting supercomputers,
>>> grids, etc...
>>> much more open to Linux, Open Source etc. The Corporate side is
>>> more
>>> conservative, more MSFT / Solaris-oriented but they equally share
>>> regulatory
>>> compliance painpoints.
>>
>>> Healthcare likewise, comprises clinical operations as well as
>>> Insurance
>>> Processing. On the hospital floors, and in the clinics, you are
>>> likely to
>>> see most apps delivered by Citrix Presentation Server (XenApp) which
>>> actually does a pretty good job of enforcing security. I can see
>>> why it is
>>> so popular where "locked-down" thin clients have no way to capture
>>> patient
>>> data.
>>
>>> Though I work strictly on the XenServer side of Citrix, I am
>>> becoming
>>> increasingly impressed by how their 18-year-old technology is
>>> relevant today
>>> (even more) in CC environments. They answered a lot of the
>>> concerns being
>>> discussed here over a decade ago ...
>>
>>> I dont see a lot of dBase III apps anymore (which is shame... I
>>> was once an
>>> ace Clipper jockey back in the day ...)
>>
>>> On Mon, Dec 22, 2008 at 10:21 AM, Sal Magnone
>>> <salmagn...@gmail.com>wrote:
>>
>>>>>> I don't think it's as easy with SoX as saying 'as long as
>>>>>> somebody
>>>>>> takes care of compliance issues'...
>>
>>>> Yes, but it's common with HIPAA. The easiest way to unload your
>>>> privacy
>>>> concerns is to actually unload them. Now that doesn't really remove
>>>> liability but it does show a reasonable attempt and spreads the
>>>> liability
>>>> around. From the perspective of many in healthcare at the top,
>>>> anybody
>>>> handles IT better than they do.
>>
>>>> One thing in this thread that I noted (and this applies to my last
>>>> statement) - we seem to be lumping PHARMA in with Healthcare
>>>> (actual care
>>>> and care facilities) and healthcare related services (like
>>>> utilization
>>>> management and TPA activity). These are three different worlds
>>>> from a
>>>> requirements and corporate IT sophistication standpoint. These
>>>> three is
>>>> clearly in three different evolutionary places with the odd
>>>> exception.
>>>> They
>>>> are also in three different mindsets.
>>
>>>> For the most part this is the way I see it-
>>>> PHARMA is about science as well as money and they know how to use
>>>> technology
>>>> and embrace it.
>>>> CARE is about the same but with much greater aversion to cost and
>>>> complexity. Lot's of COBOL in hospitals. Everything costs too
>>>> much but
>>>> they'll use if they have to.
>>>> SERVICES is the place where desk fans are cooling i486 boxes with
>>>> 100meg
>>>> HDs
>>>> running DBASE III+ apps that are backed up to local tape (maybe).
>>
>>>> /Sal
>>
>>>> -----Original Message-----
>>>> From: cloud-computing@googlegroups.com
>>>> [mailto:cloud-computing@googlegroups.com] On Behalf Of Daniel
>>>> Drozdzewski
>>>> Sent: Monday, December 22, 2008 9:43 AM
>>>> To: cloud-computing@googlegroups.com
>>>> Subject: [ Cloud Computing ] Re: State of affairs : Moving
>>>> Healthcare
>>>> Appli
>>>> cations to the Cloud..
>>
>>>> On Sat, Dec 20, 2008 at 8:23 PM, Jan Klincewicz
>>>> <jan.klincew...@gmail.com> wrote:
>>>>> I have sold into many Pharma / Health Care customers, and they
>>>>> do have
>>>>> serious compliance issues. That being said, they were often
>>>>> more than
>>>>> willing to outsource their operations to HP / IBM / EDS etc. As
>>>>> long as
>>>>> SOMEBODY takes care of the compliance issues, I think they will be
>>>>> satisfied. There is no real magic to it, other than reams of
>>>> documentation,
>>>>> paperwork, change controls, lock-downs etc.
>>
>>>> Hey guys,
>>
>>>> I don't think it's as easy with SoX as saying 'as long as somebody
>>>> takes care of compliance issues'...
>>
>>>> Isn't the point of SoX to impose as many in-house safety measures
>>>> and
>>>> double checks within the company as possible together with
>>>> reporting
>>>> to regulators?
>>>> (In)famous section 404 talks solely on internal controls and risk
>>>> assessment.
>>
>>>> This makes me think, that for the cloud to be picked up by big
>>>> companies (that have great deal of SoX compliance need), cloud
>>>> vendors
>>>> must provide service that is open to attestation by the customers
>>>> and
>>>> can provide strong assurance (by the application of crypto,
>>>> protocols,
>>>> certificates, etc) so that not just a contract with the vendor, but
>>>> used technologies and protocols impose properties needed by the big
>>>> business.
>>
>>>> I also agree that 24/7 availability is another issue that needs
>>>> addressing for mission critical apps to me moved up to the clouds.
>>>> Tandem(HP-Non Stop) and few others provide the hardware platform,
>>>> but
>>>> there is also need for replicating protocols, assurance of data
>>>> integrity across duplicated nodes etc. It is considerably easier to
>>>> run one specialized application on a resilient hardware (stock
>>>> exchange, ATMs, etc) than to provide flexible hosting service that
>>>> remains resilient.
>>
>>>> Do you guys know about any such software solutions? Any pointers
>>>> appreciated!
>>
>>>> Regards,
>>
>>>> Daniel
>>
>>>>> Granted, they are harder customers than most, but there is no
>>>>> compelling
>>>>> reason for them to need to do everything in-house as long as
>>>>> regulations
>>>> are
>>>>> met.
>>
>>>>> On Sat, Dec 20, 2008 at 3:05 PM, Johan Louwers <sun...@dds.nl>
>>>>> wrote:
>>
>>>>>> I think that specific clouds will come for for example banking,
>>>>>> medical
>>>>>> companies and such. The clouds will have been developed with
>>>> consideration
>>>>>> for sox and such requirements.
>>
>>>>>> those markets will be small, however the company who will start
>>>>>> it will
>>>> be
>>>>>> able to make a fair deal of money from it.
>>
>>>>>> regards,
>>>>>> johan louwers.
>>
>>>>>> -- origineel bericht --
>>>>>> Onderwerp: [ Cloud Computing ] State of affairs : Moving
>>>> Healthcare
>>>>>> Applications to the Cloud..
>>>>>> Van: Sankar Nagarajan <nagarajansan...@gmail.com>
>>>>>> Datum: 20-12-2008 19:28
>>
>>>>>> Today,Many IT departments are evaluating the privacy, security,
>>>>>> and
>>>>>> governance issues of public compute clouds, and some may decide
>>>>>> it's a
>>>>>> route they're not willing to take. (See Bob Evans' related post
>>>>>> on
>>>>>> InformationWeek's Global CIO blog :http://tinyurl.com/cloud1)
>>
>>>>>> On the other side ,There is much debate going on in terms of
>>>>>> deploying
>>>>>> certain consumer and medical/healthcare applications with
>>>>>> sensitive
>>>>>> or personal consumer data on the cloud (http://preview.tinyurl.com/
>>>>>> cloud2) as being 'Un-ethical,Illegal and Untrustworthy"
>>
>>>>>> Another point to consider is , Pharma /Life Sciences companies
>>>>>> have
>>>>>> strict FDA and Sarbanes-Oxley related policies and compliance
>>>>>> tightly
>>>>>> tied to their IT Systems and operations
>>
>>>>>> Given the above, What is your viewpoint on How the trend will
>>>>>> evolve
>>>>>> for this industry?
>>
>>>>>> Do you think this would be one of the Industry verticals that
>>>>>> would
>>>>>> see a *Lower Adoption* of cloud computing?
>>
>>>>>> Do you think Technology and solutions are fast evolving that
>>>>>> its a
>>>>>> matter of time before Healthcare or Pharma firms will find
>>>>>> answers to
>>>>>> the challenges faced by them today? or Would the Cloud Vendors
>>>>>> evolve
>>>>>> specific solutions to cater to this industry alone?
>>
>>>>>> Please share your views....
>>
>>>>>> - SANKAR NAGARAJAN
>>>>>> http://www.linkedin.com/in/nsk007
>>
>>>> --
>>>> Daniel Drozdzewski
>>
>>> --
>>> Cheers,
>>> Jan
>>
>> --
>> 678 467 3504
>> Agile Development Blog: IndefiniteArticles.com
>> Stone Magic: Stonemagic.Picobusiness.com- Hide quoted text -
>>
>> - Show quoted text -
>
> >
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