iPhone meet SharePoint. SharePoint meet iPhone.

""Pleased to meet you.""

http://www.youtube.com/watch?v=gGaEmG2fPkY

'nuf said

vaCTMS: The Mother of All Clinical Trial Portals

Having recently returned from a CBI conference in Philadelphia entitled the inaugural, 1^st ever "Investigator Portals something…" I'm convinced more than ever that by some happy accident VA (that's the Department of Veterans Affairs) has been sitting on the Holy Grail, Mother of All Clinical Trial Portals since 2003 and doesn't even realize it. It's like dusting off a DaVinci from a yard sale. Except this one still's got the dust on it. Paul Bleicher (ya gotta like this guy) of PhaseForward fame journaled a while back that it will be some years before industry comes up with a truly paperless trial management system with fully integrated EDC/CTMS. Well Paul, I'm here to tell you, it's been sitting under your nose since 2003 and if it was a snake, it would have bit all of us.

"The System" is affectionately referred to as the vaCTMS. Clever. VA is looking to transfer this technology so they can make some noise, "benefiting veterans through research". I agree that it can and will do everything possible to make this happen.

So to get a piece of this territory before the shark feed all you've got to do is pick up the phone and dial david.rose@va.gov.

Word.

Buy this Blog @ eCTMS.com

SharePoint Clinical Trial Management Solutions: Provisioning Modular, End-to-End OOB and Custom SharePoint / InfoPath CTMS / EDC solutions.

The first and most experienced vendor of SharePoint based clinical trial solutions. Enabling industry to manage clinical trials on the same platform used to manage the enterprise. Leverage current investments, scale and absorb future technologies.

eCTMS specializes in the development, implementation, and support of SharePoint, InfoPath, SQL and all Microsoft .NET solutions for the health research industry. Our flagship products, sharepointctms.com and infopathedc.com usher in a refreshing new paradigm to the digital management of clinical trials. With Microsoft CTMS and EDC price points are smashed and customers can now rely on thousands of Microsoft partners for training and support all within a familiar user interface. Off the shelf portal technologies are rapidly becoming the standard for a Buy-then-Build strategy in development of enterprise clinical trial management systems and with our base system you'll be able to easily extend your functionality to rapidly respond to changing business needs. Too much is at stake to risk precious resources on rapidly aging or inadequate technologies. Bet on Microsoft CTMS and EDC today and you won't be wrong tomorrow. That's Job Security right there.

Bet on Microsoft CTMS and EDC today and you won't be wrong tomorrow.

With eCTMS you can purchase ready to go systems and start managing clinical trials on Microsoft SharePoint and InfoPath for EDC today. eCTMS investigator portal templates instantly create electronic web based study logs available at the push of a button and can be provisioned for all data capture required for Good Clinical Practice, including Adverse Event management, Protocol Deviations and Case Report Forms. Collaborate, create, capture and manage IRB dates, invoices and billing, training, key personnel, enrollments, study documents and all things clinical trials on one system. Self service and granular administration rights are built in and users can take advantage of the hundreds of Microsoft supported features of SharePoint portal like extensive search, policies, archiving and workflows. Use the portal to window other apps already up and running including SAP, Oracle databases or any other system currently in place including legacy document management systems.

BACUN Fall 2009 Meeting Debriefing

The Boston Area CDISC User Network Fall 2009 Meeting Report

Sue Dubman's BACUN meeting held at Genzyme, Boston was an eye opener. Stephen J Ruberg PhD of Lilly went on about the slow pace of standardizing terminologies within the current CDISC "operational data model." That, volunteer teams that meet twice a month to plod through a particular medical/research domain to come up with common terms. He gave an example of the TB domain which took 18 months to determine some 80 or so standard terms to be used when defining TB related studies. That's not going to keep up with the new terms/concepts developed each minute in the scientific literature, much less define scientific concepts from the last million years of civilization. At least not in my lifetime. Useless. Shame too, because as Stephen pointed out, industry would like to have these standards. After all, we all agree it's a good idea. Trouble is, CDISC has taken the lead on this and they're not getting it done. He offered an "alternative?" ODM for getting this done. He also pointed out that Lilly has started their own repositories of terms, forms and such and has defined them in the latest CDISC spreadsheet style and he welcomes anyone interested to participate in adding or taking from their homespun repository. They used Formedix's ODM designer tool for the job. Mark Wheeldon, CEO? Of Formedix pointed out that this data is available on Codeplex somewhere. Have at it.

CDISC is Wonderful

It's nice having a standardized data structure we can count on. Forget about data interchange, I like it because its easier to create interoperable tools for working with the data. This then helps us leverage other's work/tools to extend our own toolset in one big glorious metric/CDSIC based toolshed world. So HL7 can just go away, please. I don't want to start this whole toolmaking thing over. Besides, HL7 is a U.S. thing and that's just not working for me anymore. We've got our standard. Leave us alone.

please

Microsoft Clinical Trial Management Solution

...and another thing.

...about all this crap with HL7 ramming itself into CDISC. This forced merger has created another layer of complexity that is already almost too much to bear. Pity the poor study managers who just want to pass audits and now must mouth not only CDISC but then HL7 XSLT XML transformation gobbledegook??? And for the developers??? Forget about it. Never ending story. Talk about mission creep. It's all too much operationally. People need to post up with Jozef Aerts of xml4pharma and get the lowdown. Not good. C'mon people, sound out if you're in this space or forever hold your peace. This is a marriage from Hell.

Here's one for ya: How can something that is constantly changing be called a "Standard?"

Sign me – eternally confused

sharepointctms.com

OK. Let's Call a Spade a Spade.

I'm done mincing words. Off the shelf portal technologies will be the standard for a Buy-then-Build strategy in development of enterprise clinical trial management systems. Same goes for form development tools. Industry has chosen SharePoint as the portal standard. I like InfoPath for EDC.

Not a siloed solution my ass. They're the very definition of a silo in a world with Enterprise portal technologies. I give MediData and Phasewhatchamacallit about one year before they start touting how they integrate with SharePoint.

Putting money where my mouth is, I just bought sharepointctms.com and infopathedc.com

Tell me I'm wrong.

love,

dave

The Future of EDC Development Tools

The market will evolve to embrace tools based on generic forms development applications with features configured specifically for Clinical Trials. Industry leaders are currently Adobe (Liquid Forms stuff) and MS (InfoPath). Proprietary forms development tools exist today only because they add-in features for clinical trial adaptation that are otherwise unavailable in current versions of Adobe and MS forms development tools. If I were an EDC vendor why would I want to support development of baseline form creation capabilities such as adding in validations, rules, views, roles, privileges, signatures, etc. on top of having to code for integration with web services, databases, xml, n-tier technology etc.. It's almost like trying to create your own word editing program so you can write a protocol. If I were a customer of an EDC vendor I would start looking at the underlying technology and who supports its future development. If it's not Adobe or MS, it's not going to be here long.

 

Sign me- you heard it here first

SharePoint Clinical Trials Portal and Pigs Wearing Lipstick

SharePoint Clinical Trials Portal and Pigs Wearing Lipstick

People are using the word "Portal" a bit loosely these days, to describe web enabled EDC (electronic Data Capture) and CTMS (Clinical Trial Management Systems). Defined as a "a window or gateway to something" I suppose it works, but in the technology sphere, the use of the word "Portal" implies functionality far beyond a round window on a submarine. As an example of this new definition SharePoint represents all that is good about portal technology. It's the modern day reference and will be the Gold Standard by which all others are compared. [ I think its forerunner, at least a similar technology that received wide recognition amongst its field, was DotNetNuke].

The stack provides features that we're coming to expect when using the word Portal to describe certain web based systems. A portal must provide the ability to template sites and functionality. It needs to provide for interconnectivity between sites built on the portal. It should also provide a non-programmatic method for creating these sites and flexibility provisioning these sites with functionality. What is considered "Standard" functionality for portal software is evolving to include document management, workflow, search, lists and granular administration rights and management. Perhaps most importantly it has to allow the user the capability to add their own modules, code and extensions so the platform can integrate with other line of business apps the company is dependent on i.e. it needs to serve as a development platform so stakeholders can respond rapidly to changing business needs.

So next time someone tries to dump their overpriced kludged clinical trial management system or EDC tool on you as a "Portal", ask yourself if what they're offering is really a modern day Portal technology or just another siloed pig in a polk wearing lip stick. If my company were busy installing SharePoint for the enterprise management of business affairs, I'd fire anybody on the spot that didn't recommend one of the available SharePoint solutions for clinical trial management and electronic data capture. It’s a no brainer.

sign me,

You're Fired!

Visio 2010 Workflows Revealed?

Visio 2010 Workflows Revealed?

Not. They might be useful but there isn't a clue to how the images hook up to the objects… if anybody knows, please provide. SPD Workflows even more mysterious.

Breaking News: some info here but still slim guessing:

"..Once you're done with your workflow you can validate it, so that you have not missed any branches or any mandatory information. Then you save it as a Visio or file or better export it as a Visio Workflow Interchange (.vwi file).
In Visio you can only make the actual design of the workflow, not the configuration which is done in SharePoint Designer 2010.
The .vwi file is a zip compressed file containing the XOML files (XAML files for workflows) and some Visio information. This XOML file can of course be opened in Visual Studio for editing, you just require the SharePoint 2010 dlls :-)..."

http://www.wictorwilen.se/Post/Creating-SharePoint-2010-workflows-with-Visio-2010.aspx

and a bit more here:

http://www.visguy.com/2009/08/10/visio-2010-sharepoint-workflows/

Office 2010 SharePoint Designer Findings…

Near as I can tell from the beta, you can't do anything with it unless you've got it hooked up to a SharePoint 2010 Portal. But who's got one of those? Anyway, until Portal 2010 becomes more widely available for testing, SPD 2010 is a useless download of bits…

NO Brainer: CTMS/EDC on SharePoint. Why fight it? Microsoft’s SharePoint Thrives in the Recession - Bits Blog - NYTimes.com

Microsoft’s SharePoint Thrives in the Recession - Bits Blog - NYTimes.com

Microsoft’s SharePoint Thrives in the Recession
By Ashlee Vance
Hang around at Microsoft’s Redmond, Wash., headquarters for five or ten minutes and someone dressed in khaki pants and a blue shirt is bound to tell you about the wonders of SharePoint — one of the company’s most successful and increasingly controversial lines of software.
Think of SharePoint as the jack-of-all-trades in the business software realm. Companies use it to create Web sites and then manage content for those sites. It can help workers collaborate on projects and documents. And it has a variety of corporate search and business intelligence tools too.
Microsoft wraps all of this software up into a package and sells the bundle at a reasonable price. In fact, the total cost of the bundle often comes in below what specialist companies would charge for a single application in, say, the business intelligence or corporate search fields.
It can’t do everything. Executives at Microsoft will readily admit that the bits and pieces of SharePoint lack the more sophisticated features found in products from specialist software makers.
“We don’t claim we do everything,” said Chris Capossela, a senior vice president at Microsoft. “If we do 50 percent of the functions that these other companies do, but they’re the ones customers really want, that’s fine. The magic is that end users actually like to use the software.”
This strategy seems to have worked even during the recession.
While Microsoft’s Windows sales fell for the first time in history this year, its SharePoint sales have gone up. Microsoft declines to break out the exact sales figures for the software but said that SharePoint broke the $1 billion revenue mark last year and continued to rise past that total this year, making it the hottest selling server-side product ever for the company.
Companies like Ferrari, Starbucks and Viacom have used SharePoint to create their public-facing Web sites and for various other tasks. All told, more than 17,000 customers use SharePoint.
In many ways, SharePoint mimics the strategy Microsoft took with Office by linking together numerous applications into a single unit. This approach appeals to customers looking to save money and also represents a real threat to a variety of business software makers.
Many of these specialists like Cognos, a business intelligence software maker, and Documentum, a content management software maker, have been gobbled up by larger players looking to create their own suites. I.B.M., for example, bought Cognos, while EMC bought Documentum. Other companies like Autonomy, a maker of top-of-the-line corporate search software, remain independent.
Crucially, Microsoft has found a way to create ties between SharePoint and its more traditional products like Office and Exchange. Companies can tweak Office documents through SharePoint and receive information like whether a worker is online or not through tools in Exchange. These links have Microsoft carrying along its old-line software as it builds a more Internet-focused software line.
“SharePoint is saving Microsoft’s Office business even as it paves the way for a new era of Microsoft lock-in,” said Matt Asay, an executive at Alfresco, which makes an open-source content management system. “It is simultaneously the most interesting and dangerous Microsoft technology, and has largely caught its competitors napping.”
Along these lines, Steve Ballmer, Microsoft’s chief executive, has talked about SharePoint as the company’s next big operating system.
Microsoft has managed to undercut even the panoply of open-source companies playing in the business software market by giving away a free basic license to SharePoint if they already have Windows Server. “It’s a brilliant strategy that mimics open source in its viral, free distribution, but transcends open source in its ability to lock customers into a complete, not-free-at-all Microsoft stack - one for which they’ll pay more and more the deeper they get into SharePoint,” Mr. Asay said.
A number of smaller software companies have been eager to piggyback on SharePoint’s success. Based in San Diego, Sharepoint360 provides consulting services and software development help around the product. The company started after employees at a construction company built some Sharepoint applications and decided to market the software to other construction firms.
The start-up has helped construction companies create systems for managing projects, allowing various people to check-in on the progress of a building and keep track of documents tied to the site. It has also expanded beyond the construction area doing work for NASA, Nestle and Toshiba, according to Paul West, a co-founder of SharePoint360.
The company offers to host SharePoint applications for customers. Microsoft too wants to host more software for companies as it moves toward the cloud computing model.
Mr. West recognizes that Microsoft may begin stepping on its partners’ toes. “It may certainly come to pass that they pull the switch,” he said. “That would have implications for us.”
In the meantime, however, Microsoft subsidizes training courses and consulting work for companies like Sharepoint360.
Next year, Microsoft plans to release a new version of the software packed full of more advanced features, including stronger ties to the corporate search technology it acquired in the $1.2 billion purchase of Fast Search and Transfer, a Norwegian start-up.
Best Buy uses the Fast technology today to provide on-the-fly pricing information to customers performing product searches on its Web site.
By making these more sophisticated tools available to customers, Microsoft thinks it can keep pushing niche software makers out of the way and give business people, rather than just the tech folks, a way to work with business applications.
“We believe customers can turn off some of these point solutions,” said Kirk Koenigsbauer, a general manager in Microsoft’s business software group. “With SharePoint, we can deliver a very, very approachable application to end users.”

FYI: Base SAS: PROC CDISC Field Response Release

Base SAS: PROC CDISC Field Response Release: "SAS Clinical Standards Toolkit"

"In Q3 2009, SAS expects to release a new product called the SAS Clinical Standards Toolkit. The toolkit will provide define.xml creation, SDTM validation, and eventually will cover Health and Life Sciences industry standards support. Upon availability of the toolkit, SAS recommends using the SAS Clinical Standards Toolkit to create define.xml instead of PROC CDISC. The toolkit is in active development with several additional releases planned while PROC CDISC is planned for maintenance only - no new features. The toolkit is a separately orderable component that will be available at no additional charge to SAS customers." -SAS website

PROC CDISC was a myth. I'll belive this one when I see it. -dave

CDISC enabled InfoPath and SharePoint EDC toolset

Our group has developed the first (that we're aware of) CDISC wrapper technology enabling full "awareness" of CDISC ODM specifications by InfoPath and SharePoint. The technology allows for autogeneration of InfoPath forms by externally defined CDISC ODM XML. Pretty cool. Email me if you want to learn more or would like to help to further define the project.

SharePoint and InfoPath for CTMS and EDC

Technology Background
Portals
The introduction of the Web Portal concept has been described as a major advance in internet technology comparable to the introduction of Active Server Pages। An important distinction between portals and traditional web sites is that portals allow the customization of content views and functionality based on specific users or groups providing a service orientated architecture easily adaptable to trial business process management.

The seminal “discovery” in spring 2003 for our group was that available portal technology provides a near perfect architectural framework for electronic management of the clinical trial paradigm. With tools like document management, workflow, flexible data grids, calendars, search and alerts, 90% of the functional requirements are built in. In combination with XML based web services portal software enables a common gateway for study management from inception to closure.

It is not the intention here to endorse any one vendor of portal or form technology but rather to make थे statement through example that new portal and form technologies should be strongly considered as options for developers and users of electronic clinical trial systems. Two of थे most popular commercial portal technologies are Plum Tree and IBM’s WebSphere.

Our group selected Microsoft Sharepoint Server as the portal platform for our CTMS. SharePoint Portal Server centralizes information from different systems by using the .NET Platform, Visual Studio.NET, ASP.NET, Common Language Run Time, Web Forms and Smart Pages, and a secure infrastructure. The contemporary .NET environment provided an application that fully leverages current investments, provides desktop synchronization, scales and is absorbent of future technologies ensuring a long lifecycle for the product.

Our principle of modifying existing software standards from commercial vendors as opposed to developing software from scratch allowed a small team of 2-3 to build a new platform capable of integrating multiple trials business process into one platform over a matter of months. We’ve eliminated disparate point solutions and dramatically reduced development costs. Basic technical support and future development of generic functionality will be done by the large vendor and their numerous “partners” freeing us to focus our expertise in development specific to clinical trials.

Forms
InfoPath is one of several new applications that enable the display and entry of data in a WYSIWYG forms based application without the need to write code. Other similar technologies are available from both Adobe and the W3C recommended standard for Web Forms, XForms. These new forms based applications are enabling the creation of XML data by the application instead of in a proprietary format. They also facilitate distribution of the forms over the web and entry of data both online and offline.

Emerging standards such as XSLT: XML Style Sheets, XPath query specifications, XSD: XML Schema, XML Digital Signatures, Namespaces, Webservices: SOAP, WSDL, UDDI make it possible to specify aspects of an application in XML rather than in code. The forms allow separation of the form’s logic from its presentation rendering forms device independent, because the data model can be used for all devices. With the data in XML format instead of a proprietary format it can easily integrate into multiple applications. InfoPath is able to integrate these standards with MS Office technology, allowing for synchronization with the desktop.

Portals (CTMS) + Forms (EDC)
InfoPath is used to create EDC tools for recording clinical data obtained from clinical trials of pharmaceuticals and devices. InfoPath forms are distributed and maintained on Sharepoint Server form libraries. SPS serves as the CTMS. When combined the two technologies provide a platform for rapid creation of full featured XML based electronic clinical trial management portals.

Technology Overview

An Enterprise Scale Integrated Research Platform.

Organizations that manage clinical trials who are also adopting enterprise portal technologies should be aware that through a strategy of adding minor modifications to off-the-shelf portal software and application of available XML-based WYSIWYG form technologies, our group has modeled an inexpensive but powerful Web-enabled clinical trial management system that leverages current investments, scales to enterprise level, and is absorbent of future technologies. Industry can now fully integrate clinical trial management solutions within the same portal platform used for enterprise business processes.

The Department of Veterans Affairs (VA) recognized new portal technologies out-of-the-box provide 90 percent of the functional requirements necessary for Web-enabled clinical trials management and has designed a portal-based system capable of study management from inception to closure. Unbound by legacy, VA took advantage of breakthroughs in software development environments, XML, and Web Services to provide standardization, interoperability, and 21 CFR 11 technical compliance while extending an enterprise platform to manage clinical trials. Because of the inherent modularity of portal software, the system ramps up to serve other business process needs of the organization, providing a common gateway to the whole of the enterprise making integration and presentation of disparate data sources a snap. The unique architecture also provides a price point within range of budget-constrained researchers and research organizations. Use of these technologies within VA has has been favorable. This author expects the application of portal technologies to the clinical trials paradigm to become de rigueur.

Bio-IT world post in 2004. You heard it here, first. -dave