In the style of Peter King from SI, here are a few things I think I think coming out of DIA:

1. I hadn’t noticed as many device manufacturers in previous years.  ePRO (e-Patient Reported Outcomes) is obvious – and expected – but there were a number of device manufacturers showing their devices for use in clinical trials – especially Phase I trials. 

Of course my attention was drawn to vendors who are using the Windows Embedded operating system (naturally), with companies like Phillips (with their 12 lead ECG) and others on the Spyrometry side. 

Makes sense, and not sure why I was surprised, but I was…

2. And thinking of ePRO, I was pleased to see a number of noted ePRO vendors that have begun to embrace the Windows platform with their devices.  Of note was PHT – check out the picture below of their new device:

They were showing devices on the Windows Mobile platform, along with devices running Windows XP.  Very cool.

Then I went over to the eTrials booth where they were showing the HP iPAQ device (thanks to the eTrials “hand model” for her help!) running the eTrials ePRO software.  The screenshot below is of the “how are you feeling” variety. 

After spending three days on our feet on the show floor, I’m not surprised she was choosing towards the “in pain” side!

3. On the user interface front, the folks over at Lorenz were showing a new CTMS developed using WPF (Windows Presentation Foundation) which gave them a more advanced look and feel, as well as the ability to take advantage of new capabilities in Vista and the forthcoming Windows 7 without a lot of heavy lifting.  Check out their screen shots:

With a “Ribbon” style menu interface (a la Office 2007) and other increasingly common user interface elements, the updated user interface makes the CTMS easier to use, which will lower training costs.

4. A public thank you to Chuck for hosting a group of us for dinner on Wednesday night.   Great company and conversation.  Thank you! 

5. Here is a shot of the San Deigo sunset (when the sun finally did come out!).  Note the kids swimming – the water can’t be more than 55 degrees and the temperature outside was only in the mid-sixties.  Oh to be young!

Next post: Post DIA thoughts on EHR/EMR integration.

In my opinion, the largest hurdle to a comprehensive Clinical Trials system, whether you talk about EDC or about traditional CTMS, is identity management. 

Think about it:

• You set up your EDC system, but how do you get your users enrolled?
• You create a CTMS, but how do you handle turnover at the clinical sites?
• How many user names and passwords does each PI or study coordinator have to remember?
• Is your system really 21 CFR Part 11 compliant if each PI and study coordinator writes their username and password on a sticky note and sticks it to their monitor?

What is the answer to those problems?  Is it SAFE BioPharma?  SAFE Digital Signatures absolutely have their advantages, and undoubtedly have a role for verifiable digital signatures, but even with SAFE users have multiple identities – at a minimum they have their corporate identity and a SAFE identity. 

Let’s pose a couple scenarios:

• What if those users could use that one identity on all systems, across multiple companies – including their SAFE identity?

• What if your principle investigators were to log onto their computer in the morning and NOT have to enter their username and password again to get into your CTMS system or EDC system (outside of a signing password)?

• What if you didn’t have to worry that the study coordinator is no longer with one of your clinical trials sites – because their username access was revoked once their employment status was changed?  What if you didn’t have to lift a finger to do it?

Allow me to introduce you to Microsoft “Geneva”, the “Geneva Framework”, and the Microsoft Identity Federation Gateway.  http://www.microsoft.com/geneva

Geneva is (essentially) the next version of Active Directory Federation Services with a key additional component: a Microsoft provided cloud based service for sharing Active Directory entries  between organizations.

The official line (from the Geneva splash page) is that it is “an open platform that provides simplified user access and single sign-on for on-premises and cloud-based applications in the enterprise, across organizations, and on the Web.” 

From a technical standpoint, the Geneva framework is designed to be interoperable, utilizing WS-* and SAML 2.0.   The key to understanding Geneva is the notion of “claims” and STS (Security token Service).

A claim is simply a way of expressing who you are – an abstraction layer for authenticating, authorizing, and obtaining information about users and services.

For instance, the following are the claims that are provided when I log into my work machine:

• E-Mail: ljordan@microsoft.com
• Employer: Microsoft
• Group: Life Sciences Industry Unit
• Role: Industry Technology Strategist
• Location: Mobile/Home Office

These claims are provided to me by the STS when I authenticate, passed to me in a SAML token, and then provided to the application I want to use. 

Applications that I try to use would then evaluate those claims to authenticate and authorize my access.   Here is a slide from a recent presentation that gives a visual overview of the process:

There is a great whitepaper that goes into detail on the process located at: Geneva Claims Based Access Platform

From an administrative standpoint, it provides a number of advantages:

• Software vendors (like EDC vendors) can develop applications that don’t have to maintain their own username and password database, but instead use a FAR MORE SECURE claims infrastructure that gives them the ability to authenticate not just users from one company, but users from multiple companies!
• Companies that utilize Microsoft Office SharePoint Server can set up authentication and access control that consumes Geneva based identities, giving you the ability to have multi-company collaboration without a lot of technical heavy lifting. 
  • This would allow a CRO to host multiple Pharmas on their SharePoint extranet site, giving them their own secure collaboration areas, without having to provision a username and password for each external user.
  • This would allow a CTMS vendor on SharePoint to provide out-of-the-box extranet capabilities, without having to provide administration screens and databases for external usernames and passwords.

Thinking of SharePoint in particular, the following slide gives a brief example of what that would look like:

To wrap up, here is a slide from a presentation I gave recently on what the whole Identity Software + Services stack would look like.

Note: if you aren’t using Active Directory or Identity Lifecycle Manager, the above architecture still is valid as the system is designed for interoperability.  There are whitepapers available at http://www.microsoft.com/forefront/geneva/en/us/WhitePapers.aspx that detail use of Geneva with Novell Access Manager as well as with Sun Open SSO.

A more detailed discussion of the Geneva platform will be provided in a Webcast that I would recommend to anyone in the Life Sciences industry on June 23rd.  TechNet Webcast- Simplified Access and Single Sign-on with Microsoft

Of course, I’m biased in positing that this is a “game changer” for the Life Sciences industry, but I truly believe it is… the issue of Identity Management, Username and Password proliferation, and cross-company collaboration is an issue that has hindered true (and secure) data availability and collaboration in the Life Sciences industry.  Perhaps now we can get the Identity Management issue behind us and move on.

Interesting how weeks become months when you're writing and updating blogs.  This CTMS project certainly hasn't gone away, but it did go on a bit of a hiatus while my "day job" intervened.  Enough excuses.  Mea Culpa.  On to the fun!

As we discussed in the previous post, the key to a clinical trials management system is thinking of it in terms of a project - after all, the people who run the clinical trial think of it in terms of a project, and it is measured in project management terms, so why not treat it that way from an architectural point of view?

A second and equally important "requirement" is one that we are increasingly seeing as an industry trend: having EDC (Electronic Data Capture) functionality and CTMS (Clinical Trials Management System) functionality in the same system, or at the very least having EDC and CTMS closely integrate and interoperate.

The clinical trials world of today is fairly fractured.  Think of all the different systems - often standalone systems - that are used by Life Science organizations:

• EDC - Electronic Data Capture
• CTMS - Clinical Trials Management Systems
• CLIP - Clinical Investigator Portals
• Project - Clinical Trials Project Management
• Analysis - OK, it's SAS, but how do you get the data there?  What about real-time analytics?
• IRB & DSMB - Outside organizations with their own management systems, like a Click Commerce Research Compliance Automation solution?

What if you could have a system that gets close to doing all of that - or at least being able to manage all of it - through one interface?  How much would that save in training costs, integration costs, and implementation costs?

Well - that's the vision.  Here's how we pull it off:

1. Start with Microsoft Office SharePoint Server 2007 and SQL Server 2008 as the foundation to build upon.
2. As discussed in the last post, we'll use Microsoft Office Project Server as a way to organize the information and provide us with a trial specific taxonomy, along with roll-up of reporting metrics.
3. To cover the EDC aspects, we'll utilize Microsoft Office Forms Server 2007 - which is a web facing InfoPath solution - to handle data entry and front-ending the workflow for data checks, etc.

EDC forms in Forms Server can even handle digital signatures (with compliance and security being the subject of a future post) inside the InfoPath forms.  This has implications for those organizations that are involved with SAFE BioPharma (worth checking out).

The beauty of all of this is that it is all Web Service enabled, which means that you have easier integration mechanisms with existing analysis and EDC systems:

• SAS - With integration with .NET, SOAP, and Web Services.
• Medidata - We've demonstrated use of their Web Services API module that utilizes CDISC.
• Perceptive Informatics - At the DIA annual meeting a couple years ago, we did a demonstration using DataLabs (now Perceptive) and InfoPath integration, using Web Services and about 5 lines of code!
• EHR/EMR Integration - While it is still on the horizon, I think it is getting closer.  Check it out.

Resources to get you started:

• Configuring SharePoint for 21 CFR Part 11 Compliance
• Project Server and Office SharePoint Server 2007 Integration
• Project Server Architecture and Programmability
• InfoPath Forms Server Form Template Authoring
• Microsoft Clinical Trial Initiation solution

Finally - there are other organizations and software vendors that are thinking along these lines.  Check out the following solutions:

• A solution in place in the US Department of Veteran Affairs
• TENALEA - Trans European Network for Clinical Trials Services
• Transenda - An Office & Project based CTMS system
• StreamLogic - A Project Based CTMS system

Next up in this series:

• Using MOSS templates for maintaining Part 11 compliance
• Extranets & Identity Management
• Architecture Diagrams & Screen shots
• Validation and compliance

I have been asked - numerous times - "is it possible to do 'x' with out of the box Microsoft tools?"

The list of things people ask about are numerous, but one of the most frequent requests of late is around building a clinical trials management portal.  Interestingly enough, for DIA this year (as discussed in a previous blog post), I built a CTMS demonstration using basic Microsoft tools (and very little coding).  My goal here is to share that knowledge.  And so, over the next few weeks I'm going to detail how we built a CTMS using as much out of the box as possible (and I'll give the code where it wasn't possible).

To start any discussion about application design and development (or configuration) requires a detailed list of requirements, but I want to start with a high level requirements premise: it's about the project! 

Think about it.  What do clinical trials managers do?  They manage projects!  A pretty fundamental thought, but boiling it down to that basic a premise allows us to make a basic architectural decision:

• If it's about the project, then let's design the architecture around project management. 
• Which means that we'll be using Microsoft Office Project Server as the basis for our system.

Microsoft Office Project Server, which is part of the Office SharePoint system, provides us with all the project management capabilities, plus because it is based on SharePoint it gives us all the document management capabilities that we'll need as well.

What then are the requirements for a Clinical Trials Management system?  Well, your mileage may vary, but in my estimation they are:

• 21 CFR Part 11 Compliance - Audit trails, version histories, and electronic or digital signatures are all required.
• Enterprise Document Management Capabilities - Version control, version histories, check-in/check-out, workflow, capture the metadata during document authoring, centrally manage the metadata taxonomy.  There are more, of course, but we'll start here.
• Clinical Site Management - Some people will call this functionality a clinical investigators portal
• Study based document management
• Site specific document management
• Task management - both for internal and external users (i.e. sites)
• Issue management - largely for internal users
• Task monitoring and completion reporting
• Key Performance Indicators - both on the project level, on the site level, and roll-ups for executive dashboards

Of course, there are many more - and more detailed required for them - but this is a blog after all, so enjoy the ride as we walk through this system together!

It's amazing how many times we get asked that question!  "Is SharePoint validated?"

Despite the number of validated applications written by ISV's that are running on SharePoint,

...despite the overwhelming adoption by life science companies who are using SharePoint for everything from team collaboration (the obvious) to dashboards in their manufacturing environment to managing their clinical trials to managing their compound and project portfolios,

...and despite the publication over a year ago of our whitepaper with Guidance on Configuring SharePoint for Part 11 Compliance,

despite all that, we still get asked that question.

Well, the answer is an overwhelming "yes, SharePoint is validated"! 

And while the case studies themselves are just now coming out (Clinical Trials Support, Manufacturing Support), there are even more customers who have been through a validation effort with SharePoint and are willing to talk about it.

So, the next time you wonder if SharePoint is validated, or someone asks the question, the answer is a resounding "yes!"

I recently started using the GPS functionality in my AT&T Tilt (HTC 8925).  About the same time, I downloaded a new version of the Microsoft Windows Live Search Mobile (or http://m.live.com from your mobile phone).

Very easy to set up:

1. Download Live Search Mobile on your phone from http://wls.live.com
2. Allow the .CAB file to install
3. Launch Live Search from your Smartphone's Start menu
4. Click on "Menu" and "Settings"
5. You'll want to "Enable speech recognition" and for the ATT Tilt select "GPS COM4"
6. Click on "Done"

That's it!  Now you're ready to GPS navigate on your Tilt (or almost any GPS enabled smartphone as I understand it!):

1. Click on Directions, and choose your "New starting location" from your "Current GPS position" entry
2. Name your location (the default GPS Location will do, but it will ask you to overwrite it the next time) and click Done
3. Then choose your "New ending location".  Because you selected "Enable speech recognition" you can click "Speak" and speak the location, or you can type it in, or choose from your Outlook or SIM contacts.
4. Click "Route" and the route will generate.
5. Once the Route is selected, click "Map"
6. Once the Route Map is displayed, click Menu>Center on GPS

It'll give you turn by turn directions, notifying you with a beep when you get close to your next turn, when you're at your next turn, and when you are on the next direction.

I'm at the point now where I never leave home without it!!!

While at DIA I was asked an interesting question by Mark Uehling for his Clinpage blog, "what do you think is the future of EDC"?  Kind of an interesting question, and my answer (which I'll let you read in his newsletter blog) was informed by how connected the industry has become in terms of interoperability.

It became obvious at DIA that there are a number of vendors who "get it": it isn't just about their own functionality, rather it is about the functionality that can be gained when linked with the functionality of other companies.  Out of the box. 

Yep: I'm talking about interoperability.  Web Services.  Architecture.  The foundations of which Microsoft has built their current offerings of products on.  It's all about "playing nice in the sandbox" and working with other companies technologies, regardless of the stack that those technologies are utilizing.

Let me give you an example: at a large pharmaceutical company, I've seen a system that takes information from Medidata (via webservices and CDISC), feeds it into their backend SQL Server system (via webservices), allow access to that data for reporting and submission generation purposes (via webservices), and provide dashboarding capabilities from Microsoft Office SharePoint Server 2007 (via webservices) to their executives so they know what trials are behind schedule and can find out why and intervene.

Another example came from DIA a couple years ago. We did a demonstration with DataLabs (now Clinphone), where we:

1. Entered data into a "Patient Enrollment" CRF and saved the information. 
2. Opened up Microsoft Office InfoPath (yes, a forms application from Microsoft!)
3. Utilized InfoPath to query the WSDL (Web Services Description Language) server and found the Clinphone web service for Patient Enrollment that output information in CDISC format.
4. Opened up that web service in InfoPath, and populated that form with the data we just entered.

The amazing part was that only three lines of code were required to do that (to query the WSDL server as I recall).

Yep: the now happening wave of interoperability is only happening because vendors "get it", understand that interoperability can only happen when you use Web Services and a data model that people understand.

One of the cool parts of working for a large software platform vendor like Microsoft is working with the larger ecosystem of partners that are developing applications on the Microsoft platform.

In particular, as we approach DIA each year, I am faced with a conundrum of "who to invite" to present with us in the Microsoft booth.  The fun part, of course, is evaluating all the new technologies that will be announced at DIA.  The not so fun part is having to help choose which ones to share booth space!

So over the last couple months, we've spent a fair amount of time looking at new technologies, some of which are in our DIA booth, most of which are not (simply due to lack of space!)

I've gotten demos from some excellent technologies:

• NextDocs - which provides document, quality and compliance management software for Life Science companies
• FirstPoint from FCG, who are taking many of the features from their popular FirstDoc application and moving them to SharePoint.
• Transenda - which has some VERY intriguing technologies for clinical trials based on Office 2007 and SharePoint
• Intrasphere - with it's PharmaCM product that provides Submissions Management and Authoring on the Office 2007 and SharePoint platforms.
• In.Vision Research - releasing XPressAuthor for Office 2007, which takes their popular XPressAuthor application and moves it to Office 2007 and SharePoint.

Just a smattering of the applications I've seen of late, and some of the ones you'll see in the Microsoft booth at DIA.

See you in Boston!

Over the next couple weeks, I'll be blogging frequently about Microsoft will be demonstrating and showing at the 2008 DIA Annual Meeting in Boston.  We'll be covering everything from Part 11 compliance, collaboration, validation, electronic data capture, clinical trials management, and a new paradigms around data visualization.

One of the themes of our booth this year is around "Compliant Collaboration".  Now, I know what you're thinking: "those two terms - compliance and collaboration - are not often used together".  And yet, why not? 

Typically they aren't thought of together because some of the legacy systems that Life Sciences companies use for regulated document management aren't thought of as particularly user friendly, or thought of as particularly integrated with the usual authoring environments, or thought of as particularly easy to find the information that is stored in them.

And yet, that appears to be changing.  The first driver behind this is the incredible uptake on Microsoft Office SharePoint Server 2007.  The number of organizations deploying SharePoint is vast - and not just Life Sciences companies themselves, but other organizations too.  For instance, CDISC is now using SharePoint for collaborating on developing the CDISC standards. 

The second driver is the number of software vendors that are themselves adopting SharePoint, and utilizing it as a front end for their own software: Documentum, FCG (now CSC) FirstPoint, and NextDocs as examples in the regulated document management space.

But the question of compliance still comes up.  In response to that, last year we wrote a white paper on configuring SharePoint for Part 11 compliance, a white paper that has had a HUGE number of downloads over the last 12 months.  (see http://msdn.microsoft.com/e-n-us/architectur/bb286569.aspx)

This year we are going a step further by taking that white paper and implementing it in a demonstration of "Compliant Collaboration" using SharePoint in a clinical trials environment.  And then, post DIA, we'll be using this space to talk about how the demonstration was configured, and how a Life Sciences company can take that learning and apply it to their own situation.

You'll want to pay attention to this space over the next couple months, as we dive into how the demonstration was built, and how SharePoint can be used to share documents in a compliant, clinical trials environment.

So - do take a moment to drop by our booth at DIA and see what Microsoft is up to in the Life Sciences!

Microsoft is hosting the second annual Health and Life Sciences Developers Conference to be held April 22 through 24 at the Sheraton Hotel in Atlantic City, NJ.

This free - yes free - event is going to be even bigger and better than last year, with some guest speakers that you do not want to miss, including Peter Neupert, Corporate Vice President of the Health Solutions Group, the same people that brought you HealthVault (http://www.healthvault.com) and Amalga (http://www.microsoft.com/amalga).

We will also have a Microsoft Surface computer in demonstration (yep - you'll actually be able to use it!) along with discussions on a variety of industry topics.

To see the complete agenda and for registration information:

https://msevents.microsoft.com/CUI/EventDetail.aspx?EventID=1032360756&Culture=en-US

One of the questions I'm frequently asked by people unfamiliar with Microsoft's efforts in Life Sciences is: "What type of solutions does Microsoft have to offer to Life Sciences companies?"

The answer to that question is usually: "Name the part of the value chain you're interested in, and we can talk about the particular solutions".  Yes - it is that wide of an offering.  If you look at our Life Sciences page (http://www.microsoft.com/lifesciences) you get an idea.

But today I thought I'd touch on a couple focus areas for Microsoft.  While we have solutions outside of these areas, the following are solutions that are getting particular focus and traction in the marketplace:

* Compliant Collaboration - This is a combination of regulated document management and collaboration.  Traditionally these have been thought of as separate processes, if only because of the limits of the tools people used to either collaborate or manage regulated documents.  With Office 2007, SharePoint, Web Services and OpenXML as the underlying platform - including the ability to leverage open standards such as OpenXML and CDISC and industry standards such as SAFE - you have the ability to have a completely compliant environment, while still having an end-user friendly authoring and collaboration environment.  A couple examples of this initiative come from the whitepaper we published on Configuring SharePoint for Part 11 compliance, the announcement of FirstPoint by FCG (First Consulting Group), and the NextDocs suite of products.  Watch this space for more configuration information (for those who want to implement it themselves) and information on 3rd party products that enable Compliant Collaboration.

* Scientist Workbench - One of the least integrated areas of the Life Sciences value chain is Drug Discovery.  It is also an area where there is lots of ad hoc collaboration, mountains of prior art and information to be searched, and more systems to learn than a single person can get their head around.  In answer to this, Microsoft has been working with a few pharmaceutical companies and partners in development of something called the Scientist Workbench.  I'll go into more detail in a future blog (expect a whitepaper on the subject in the next few weeks), but the Scientist Workbench is focused on five areas:

1) Finding Information - call it search if you will, but this is about finding information - both public info and corporate info - in the context of how you are working.  Imagine typing a document in Microsoft Word: you type in a compound name, a SmartTag recognizes the term and underlines it, giving you the ability to do a contextual search for that compound across public and internal sources - or even do a look up of that compound in your compound database!

2) Equipment and Data Integration - The vision is to integrate all the information from all the laboratory equipment and provide the data in one place.  See the recent recent Thermo Fisher announcement for an example of this type of integration.

3) Data Visualization and Analysis - utilizing the Windows Presentation Foundation, tools such as SilverLight, and products such as PerformancePoint, to be able to easily visualize the results of experiments, to do meta-analysis, or even to look into a compound, molecule, gene, etc.

4) Compliant Collaboration - as described above, but focused on collaboration around scientific projects, and including external researchers - be they from a university or from a licensing partner (who happens to compete in other areas, so security is essential!)

5) Reporting and Portfolio Management - this deserves it's own blog topic, but this is focused on taking the results from all the experiments, integrating information on resource allocation from your HR system, and the result is a Decision Science support system that allows Decision Science managers to visualize which compounds have the greatest chance of survival to production.  Integrate the results of clinical trials, FDA submissions, and pilot production, and you have a comprehensive dashboard for executives to see the status of their drug pipeline. 

There are more, many more - including solutions in Pharmaceutical Sales & Marketing, Supply Chain, and Manufacturing, Physician Portals and Patient Portals for Medical Device Manufacturers, and - of course - basic infrastructure tools for managing your environment in a compliant way (yes, using SMS and MOM for compliance audit reports) - but I'll deal with those in a future blog. 

If you are interested in the architectures behind these, then please do send me an e-mail (ljordan@microsoft.com).  If you are interested in seeing these applications in action, then let me know that too!

Next article: An in-depth discussion on our solutions in Pharmaceutical Sales & Marketing along with solutions in Supply Chain, and Manufacturing.

Well, we've finally been able to get it posted!  The SAFE Signing Interface for Office 2007 has been posted to Codeplex, with the source code for the interface being posted shortly.

The installation executable, along with installation instructions, is now available at http://www.codeplex.com/safe.

We are also releasing the source code into open source - available on the same site - and to be available as soon as we can get it uploaded. 

Look for another posting here to that end!

While this is a reference implementation (and thus, unsupported), we are hoping that the broader community will take up the support for this important capability, extending it as the SAFE standard is extended.  If you are interested in participating as a developer on this project, please send me an e-mail at ljordan@microsoft.com

Some of you may be aware that this week is a global sales briefing within Microsoft.  A great time for the field sales force to find out about new products, get demos, get trained, etc.

One of the best presentations I saw was done by Bill Gates around the Surface Computer.  If you haven't see it yet, check out the videos on it at http://www.microsoft.com/surface.

In talking earlier this week with a VP from a large biotech, he said something that gave me some pause: "Imagine the surface computer in the research laboratory.  I can scan documents, draw compound diagrams and have them captured electronically, manipulate 3-D visualization of molecules (large or small) with my hands - without having special 3D manipulation tools.  And that's just the beginning!"

Take a look at the videos - if you get beyond the obvious consumer applicability (photos, music, etc), and think about the device recognition, think about the image manipulation, and then think about some of the data visualization and the 3D manipulation of that data as is now available from PerformancePoint (http://www.microsoft.com/performancepoint) - when you think about the surface computer in those terms, you start to get some notion of the places this could go within biopharma research and discovery.

Of course, this is a multi-day event, so I'll have more updates on new products and thoughts on their impact for Life Sciences companies over the next few days.

As part of our work with Medical Device companies (as well as with pharma and biotech companies) we've been looking at the issue of validation and how it impacts Microsoft products.  This is not a new topic: we've been working on validation and regulatory issues for awhile:

• Sharepoint configuration guidance for Part 11 which was released earlier this year.
• The Update Impact Analyzer (part of the Application Compatibility Toolkit) and how it can be used to reduce the amount of patch validation that an organization has to do (and the subject of a forthcoming MSDN article).  This tool was developed with the (significant) input of a major pharmaceutical company.
• Validated products, such as our ERP product for the Life Sciences industry (Microsoft Dynamics AX for Life Sciences)

Of course, those are just three brief examples - there are many more. 

But, here's the thing: I need your help.

I'm in the internal review stages of a document that details Microsoft's development methodology and maps that methodology into the industry "v-model", and would like the input of knowledgeable people from the life sciences industry who understand the v-model and validation.

The questions I am trying to answer:

• How will the white paper be useful to your company?
• Does it describe the v-model appropriately?

Of course, other comments are appreciated. 

If you are interested in reviewing the document, please comment to this post and I will contact you directly.

There were a couple of news worthy events that were announced today.  The first is that First Consulting Group has purchased Zorch, Inc.  Why is this exciting?

Zorch has developed a Metadata driven submission management system built entirely on SharePoint. 

FCG is now in the business of providing Microsoft based regulated document management systems, based on Sharepoint and Office.  The resulting product is called FirstPoint, and I believe will revolutionize the way that companies handle regulated documents and electronic submissions to FDA and European agencies.

From an architectural point of view, what makes this product different?  It is based on open standards and open architectures.  It makes heavy use of Web Services, Service Oriented Architecture (SOA) and OpenXML, with the resulting output being an eCTD (which is an XML file, after all).

How does this impact your IT architecture:

• SOA and Web Service based makes it easier to integrate into your environment.  Essentially this is another proof point for the Connected Life Sciences Framework.
• Word authoring interface lowers training costs by keeping your users working in a product they already know and use.
• SharePoint as the underlying architecture means that it takes advantage of a platform that your company may already own.

It's exciting to see the continued industry adoption of the Office platform through Microsoft Office SharePoint Server 2007 and Office 2007.