Microsoft in Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC)

one of the very few interesting article by Microsoft Engineers on Clinical Research Industry. Certainly interesting as it is written by none other than      Les Jordan-CTO, Life Sciences Industry Unit at Microsoft . Microsoft and IBM had much longer and deepr association with Lifescience/Healthcare/Bioinformatics industry than Oracle.

But I love to see microsoft grow beyond Sharepoint for Clinical Research and the BioIT alliance. Also love to ask microsoft what is the current status of some of those applications mentioned in the blog by Les, Especially the Microsoft Clinical Trial Initiation solution

Original article from microsoft website

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:

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

Next up in this series:

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

Google launches new Web browser

Google has launched the new google browser in Beta version. The  Google Chrome (BETA) for Windows is claiming to be a  browser that combines a minimal design with sophisticated technology to make the web faster, safer, and easier.

I downloaded it and is making this post fom the new browser , its fast is my first comment, but it still uses the IE engine just like Fiefox for its security features

Have you heard of the new feature in Internet Explorer 8 called InPrivate Browsing or rather nicknamed as Pron Mode, Macintosh users already know about this features that deletes the track record of your action in the Browser. Chomr also has a similar feature called incognito mode.

Am not that impressed I just ask my firefox to delete the cache and history automoatically every time I close the browser.

For More Details take a look at the website 

Semantic Search Engine for PubMed- Microsoft Vs Yahoo Vs Google Vs Oracle in Semantic Web Search

Hakia is a semantic web search engine, so what you might think. The difference is hakia targets legal, financial and Medical web searches. Thye have even licensed its technology to a startup company that summarized information for government and pharmaceutical companies

There is more starting from April 2008 using Hakia you can search Pubmed. Adding more than 10 million abstracts from PubMed to their index and setting up a new site dedicated to searching this content at pubmed.hakia.com. The PubMed content will also be visible in search results on the hakia medical search site and via the main hakia search page

For exmaple my query of microarray software Pubmed returned 1646 results and Hakia 15 some times having too much is not good idea, especially when you are looking for specific text.

It doesnt even stop there, the result also showed me Meet Others who asked same query in PubMed Semantic search with the option to even add a post so I found a job for part-time employee to work in a microarray lab. This I think is a great tool especially if more people use it you can use the feature to locate people working on similar topic. Ofcourse you can any of the much known social tools like Linkedin

Still not convinced of the merits take a look at the comparison of the search results on new regulatory problems affecting personal genomics companies, in google and Hakia

You can also generate a custom seach box that can be added to your website much like the custom google search box .

and yes there is competition to Powerset has launched its

May be because Yahoo is already offering Semantic webs earch using

But there is more than what meets the eye. Remember Interestingly in 2007 June Oracle staked its claim to leadership in the enterprise side of the emerging semantic Web space, saying that more than 100 commercial and open-source applications are using its version of the technology. Oracle do offer search called Oracle Secure Enterprise Search. Take a look at the Oracle Semantic Technology Centre

Microsoft can also say to be making up for the loss of TripleHop to Oracle,

There is still more surprises Evri.com a Paul Allen backed semantic search engine has launched a Beta release in June 24.

Other similar service providers includes TextDigger, Radar Networks Peer39.com that offers semantic technology in advertising, Gloofi.com Twine, then there is Spock calling itself a vertical search engine for people, usign top-down semantic search. In that sense we can call Google Maps to be using semantic technology though it cant be called a thorough breed in this field

%d bloggers like this: