Social Networking meets Clinical Trials

I have been looking at Social Computing applications for business for a while.  Frankly, it took me a little time to get by head around all this.  I just don’t see how there would be a single Killer App to solve all issues.  However, there is no doubt that Social Computing applications are becoming more mainstream.  I wanted to capture some of the more interesting applications I have come across recently.  What is also really cool about the second one is how ‘it also allows would-be subjects with a personal health record (PHR) in Microsoft HealthVault or another system to import the information in lieu of filling out an online pre-screening form to be matched for trials.’

Health 2.0: Patients as Partners

Social networks like PatientsLikeMe let people take charge of their own care—changing the nature of drug research and the practice of medicine: http://www.businessweek.com/print/magazine/content/08_50/b4112058194219.htm

New Patients Can Tweet for Trials

http://www.ecliniqua.com/2009/04/27/trialX-twitter-recruitment.html

Clinical Trials and the Microsoft platform

My friend and colleague Les Jordan has recently added a new posting to his MSDN Blog called CTMS & EDC: A system to do both – and more.  Lately, I have been thinking a lot about Clinical Trials as well, so I wanted to add my own perspective to his excellent posting.

I think Clinical Trials are another area within the Life Sciences industry that are incredibly balkanized.  Most of large pharmaceutical companies I have worked with have between 20 and 25 clinical systems that need to work together.  The effort and expense to make all this function is simply mind-numbing!  A partner just sent me some presentations from a recent CTMS conference, and I just could not believe the incredible pain and expense companies have to go through to make these systems work together.  They have no idea how much easier their lives could be by considering some alternative approaches.  And it is scary to think they actually believe they are doing cutting edge stuff.  Well, in a way they are doing cutting edge – by pouring money and resources into legacy systems which they believe to be ‘best-of-breed’.  They are literally spending millions (or even tens of millions) annually to keep these systems running and working together.  However, the reality is that nobody can afford these approaches any more, and things will have to change drastically in the Clinical Trials space, just like in all the other facets of the life sciences industry.

If I had to start from scratch, I would build a system on the following elements of the Microsoft stack: MOSS, SQL Server, Project Server, and Dynamics CRM.  These are just four ‘moving parts’, but they are designed to work together, and work with a single integrated development environment in Visual Studio.

When I think about it, it is mostly about collaboration and business process management around data and documents.  Let’s consider a simple overview of Clinical Trials, without going into too much detail, and consider what systems need to be in place.  It is a complex, convoluted process, and I would like to show that most can be done with just four ‘moving parts’.

  • First, the Clinical Trial needs to be designed.  There are a number of specialized tools that are used for this, but no doubt collaboration plays a key role.  How can this collaboration take place: MOSS, of course! 
  • Then, a Clinical Protocol needs to be written.  This is usually a complex, and highly structured document which lends itself well to automation.  We are currently working on using the Intelligent Content Framework and DITA-Maps (don’t be scared of the specialized term: think of a DITA-Map as a Table of contents and a set of rules to build a document) and to make this process as automated as possible.  The same approach also applies to Clinical Investigator Brochure.
  • The Clinical Protocol needs to be reviewed and approved by an Institutional Review Board or an Ethics Committee.  Again, this is a collaborative process.  The best tools for this are MOSS, in combination with Unified Communications.
  • Once the trial has been approved, the sponsor (i.e. the pharmaceutical company, or the CRO who they have contracted – as an aside, MOSS is a great platform for managing contracts between the sponsor and the CRO) has to select the Clinical Sites (these are mainly hospitals or research centers) where the trial will be conducted.  There is a lot of business process management and collaboration that has to take place during the so-called Site Initiation Process, and other documentation needs to be managed, such as Patient Consent Forms, Investigator Brochure etc.  Most of this is very document and forms-centric.  Our partner NextDocs has built a great module to do this – on MOSS!  There is also the need to manage all Training Records for Clinical Investigators and Research Associates, and to manage the published Clinical Investigator BrochuresNextDocs has this Clinical module built out, too.  In fact, I am even aware of a free SharePoint Services 3.0 Application Template for Clinical Trial Initiation and Management.
  • In order to conduct the Clinical Trial, the sponsor or the CRO usually puts up a Clinical Investigator Portal, where investigators log in to get all the information about the particular trial, and protocol, and can upload all their pertinent information, such as CV, completed Statement of Investigator (also known as 1572 form), etc.  MOSS is ideal for this application.  Of course, Dynamics CRM can also work in conjunction with this to serve as an Investigator Database (which needs some CRM capabilities)
  • Sponsors have to recruit patients who are interested and willing, and qualified to participate in the trial: they often put up a Patient Recruitment Portal for this application.  Again, MOSS is ideal for this application.  Our partner Quilogy has built some very impressive applications in this space (both for Patient and for Investigator Recruitment).  And of course, Dynamics CRM can also supplement the Patient Recruitment Portal application as well.  Dynamics CRM is also an ideal platform for Investigator Grant Management, another area that is ripe for a major technology upgrade – most companies are still using antiquated technologies for this application.
  • Sponsors also have to track payments and disbursements to investigators, have to track clinical supplies, etc.  This is also often referred to as a CTMS application.  There is an excellent solution for this by our partner TranSenda.  We have been collaborating closely with them on their Office-Smart Clinical Trial Manager, and they have posted an excellent White Paper about SharePoint in Clinical Trials.  We are also doing some very innovative and forward-thinking work with them around managing Clinical Trial process data, which is not an area that is covered by the Clinical Data Interchange Standard Consortium (CDISC).  See here for a great article that covers the problem space that we are addressing with Cortex™ .  The part about the Clinical Trials Interchange Platform (CTIP) is especially relevant!  The Veterans Health Administration have also built their own CTMS system on MOSS technologies.  They have the same requirements as the biopharma industry, but a fraction of the budget, so they have to be innovative and forward-thinking.  However, shouldn’t that be the business paradigm for everyone these days?  I have uploaded some materials of their solution here.  To quote Dave Rose, Chief Architect of VA’s CTMS/EDC solution set: “The system leverages current investments, scales and is absorptive of future technologies.  Imagine managing your clinical trials on the same platform you use to manage the enterprise….”  In fact, there is now also a commercial version of the application available: http://infopathedc.com/  And of course Dynamics CRM is an excellent development platform for this, too.  I posted some White Papers on the latter here.
  • Now we come to the conduct of the trial.  There are many Project-related activities related to this, and of course Project Server can be the tool of choice.  The beauty of this application is that it is built on the same foundation as MOSS, so that Project data can easily be surfaced in the Portal, and even managed from there.
  • Once trials are up and running, there is a ton of data being generated related, which is made up of patient data and process data.  Increasingly, companies are moving to Electronic Data Capture to achieve this.  This data is then fed to Clinical Databases (SQL Server is used by several partners of ours for this purpose).  Once again, InfoPath and Forms Services, part of the MOSS stack, are ideal for this.  Here is a great application from Qdabra that can seamlessly connect forms to databases.  It has great potential for EDC applications.  The problem I see all too often that there is a lot of legacy technology that has been built, and vendors are very reluctant to cannibalize their old legacy EDC tools.  It is such a shame, because InfoPath and Forms Services are built on XML, and are ideal for this ‘smart form’ application.  However, there are already several applications out there that leverage this capability.  There are our friends at the VA, there is Tenalea, and there is also InferMed
  • I do not see paper going away completely for a while as a means to collect data via Case Report Forms.  Imaging and Capture applications are also needed to get Data into the the system.  Among the solutions I have seen out there, I am a particular fan of KnowledgeLake, as a capture system for CRF data.
  • During the conduct of Clinical Trials, sponsors also need to track and manage Adverse Events data, which is fed into an Adverse Events Report System, which is essentially a specialized database.  The biggest problems many companies face are how to capture and process this data, prior feeding it into the Adverse Events Report System.  Once again, InfoPath and Forms Services, in combination with a capture and imaging system, driven by business process management in the back end an ideal solution.
  • All the EDC and scanned Case Report Forms have to be published into a Casebook, which then are collected as part of a Trial Master file.  MOSS is an ideal platform as an Electronic Trial Master File.  I just read an interesting article about this recently.  However, the NextDocs Clinical module does this, too.  There is also the issue of making sure all documentation is properly tagged and uploaded into the system to form the Trial Master file.   We have a great Case Study on the subject, where I closely collaborated with the customer and the partner who built the solution – on MOSS!
  • There is a lot of interest in Secure Document Exchange for Clinical Trials these days.  It is mindboggling to consider how much paper is still being processed, huge bills being paid to shipping and logistics companies to manage all this paper, and the interpretation of ‘electronic’ in many cases is still data burnt on a CD or DVD, and then shipped via a courier service.   In fact, the excellent article from 2002 titled ‘Tortured by Paper’ is still very much current.   Not too much progress in 7 years…..  However, as it happens, MOSS is a solution for this problem, too – and the NextDocs Clinical module is built with this purpose in mind.  I have no doubt that they will be very successful with this application.  Certainly, paper will not disappear entirely for a long time – but there are some excellent Capture solutions build for MOSS that can help reduce or eliminate the ‘torture by paper’ part: KnowledgeLake, BlueThread and Clearview are the ones I usually recommend.

By no means is the above a complete listing of all the intricacies and details of Clinical Trials, and I have stayed away from specialty areas such as randomization, IVR, biostatistics, pharmacokinetics, etc.  However, I wanted to provide a high-level overview of some of the main clinical systems and processes, and also emphasize again that it is mostly about collaboration and business process management around data and documents.  The latest Microsoft software stack is ideal for this, and it is time people realized that they can simply no longer afford the balkanized approaches of taking all these so-called ‘best-of-breed’ solutions and try to make it all work together smoothly (even if some of them still believe that Web Services will be a panacea to fix all of this).  Best-of-breed can a misnomer, too – because the Microsoft software platform is mature and powerful enough to be able to build any of the systems mentioned above, and to deliver a superior solution at far lower cost.  Why not build a best-of-breed suite on a platform that was designed to work together from the ground up?

Update February 2, 2010: we just released a brand new Case Study that I sponsored, and I am really proud of: http://www.microsoft.com/casestudies/Case_Study_Detail.aspx?CaseStudyID=4000006256  What a great success story for SharePoint being used at a CRO, helping them lower costs and run their business more efficiently!

Mr. Metadata’s Musings on Legacy Migration, e-Discovery and ECM 2.0

I had written earlier about what makes for an Intelligent Content Solution: you need Intelligent Content Design to supplement the Intelligent Content Framework.

Recently, we also started talking to some of our large customers about legacy migration approaches.  The fact is that despite the phenomenal success of MOSS, over 80% of unstructured corporate content still resides within file systems today.  Often, it is just one big mess, and leads to a tremendous loss of corporate knowledge, while creating a huge litigation liability.  There is simply no one-size-fits-all approach to solving this problem.  Applying Search technologies alone does not solve the issue.  There are a few specialized companies who I have worked with over the years who specialize in this field, such as Delve Information Group and the Gimmal Group.  I worked with a large Pharma customer a few years ago who had a team of people working on a project just to sort out the ownership of legacy content on their file systems.  It took them two years just to create a database that stored information on who owned what document.  But this information could not be turned into actionable intelligence for file systems migration.

When migrating legacy content, the following considerations need to be taken into account: 1.) Who is the owner of the legacy content?  If the person is no longer with the company, can the information be deleted, or archived?  A good tool to help with this Information Governance issue for file systems is Varonis This could be a key aid in migrating content from file systems to MOSS, and maintaining the ownership governance.  Just relying on a migration tool like Metalogix or or MetaVis only solves a fraction of the problem.

2.) Another area of consideration are the multiple redundant copies of legacy files.  According to Cohasset Associates, each content artifact has up to 18 identical copies scattered all over the place.  A key question when trying to manage the Corporate Truth is which document is the original, and which are copies thereof?  This issue alone lends itself to several approaches to e-Discovery and ‘document forensics’.  Many search engines which are combined with hashing capability can actually be adopted to find duplicate documents, and the server will store the date the document was uploaded.  So that is a start.  But that is not sufficient.  The best solution by far to address this problem is the new solution by NextPage Information Tracking Platform.  Their ‘digital threading’ technology is exactly what is needed, and I consider it revolutionary.  There is also the issue of document forensics.  This is they key consideration: if I take a document, and modify just one word in it and save it – does this make the new document completely unique (a hashing-only approach would create an entirely new hash for the document) or is this a ‘closely related’ document?  The so-called vectoring capabilities of FAST ESP can help with this problem of ‘near duplicate’ content.  There is also a tool from Equivio that can be used. This leads to some interesting possibilities when used in combination with NextPage.  This technology is actually extremely important in the case of e-Discovery, i.e. the ability to track parent-child relationships of related content, which is also a key element of an emerging area called document forensics.  There are some excellent SaaS or on-premise tools available to support the e-Discovery process, such as Digital Reef or Stratify.  Recently, we have engaged in a project where we brought together Navigant Consulting, Digital Reef and NextPage to deliver a comprehensive and integrated solution to e-Discovery.  I am very excited about the capabilities that these partners offer together.  Some of my colleagues have also been working closely with WorkProducts, who have a very interesting approach called Evidence Lifecycle Management (ELM).  There are also some interesting packaged legacy cleanup and migration tools available from Vamosa and Active Navigation.  Both vendors are emerging leaders in the Enteprise Information Governance space.

There are also several partners which take an archiving approach to e-Discovery.  See here: http://www.commvault.com/solutions-ediscovery.html http://www.avepoint.com/sharepoint-ediscovery-docave/ http://www.mimosasystems.com/html/sol_legal_discovery.htm.  However, in most cases, I prefer the federated Information Tracking approach that NextPage offers, simply because it is simply not realistic to archive all enterprise content: how about the content located on Desktops, Thumb Drives, etc. ?  And these solutions also lack the specialized capabilities that most customers need, so a solution like Digital Reefis still needed on top.

3.) Suppose we are able to perform all this cleanup and preparation work prior to being ready to move legacy content to MOSS.  Now we are still confronted with the issue of metadata.  Given that file systems have no concept of metadata, the process of metadata enrichment is extremely important.  There is some basic metadata that most search engines can extract from within documents, such as date, author name etc.  However, this information needs to be associated with the document as metadata, so it is more readily available.  However, I also have a strong belief that content without context is incomplete: there is an excellent article that I read a few years ago that describes the problem.  Legacy content needs to be metadata enriched before migration.  FAST ESP is an ideal tool for this metadata enrichment process, and for automatically building taxonomies.  We are also working on the new Microsoft Semantic Engine – the demo can be watched on-demand here: http://microsoftpdc.com/Sessions/SVR32.

4.) The final step is moving the content to MOSS, and applying all this metadata to making it useful and findable.  This is where the new MetaPoint Server by SchemaLogic comes into play.  FAST ESP and MetaPoint as an integrated solution working with MOSS are a key part of solving this problem space.  I have recently started thinking about what a an integration of MetaPoint and NextPage would look like, and delivered as a Service via the new Microsoft Azure Services Platform.  The possibilities are truly exciting!

A recent update to the above is that SchemaLogic and Vamosa have formed a technology partnership around Enterprise Content Governance.  I think this is exactly the kind of solution that companies need to address their needs around content quality, to support legacy migration, e-Discovery and Information Governance.

So now after all this discussion about Legacy Migration and metadata enrichment, let’s get back to the Intelligent Content Framework.  How does it all belong together?  The simple truth is that with Intelligent Content Design to begin with, there will be no need for legacy migration going forward.  I had already talked about Intelligent Content solutions needing the Intelligent Content Framework in combination with an Intelligent Content Design approach.  It occurred to me that if we add FAST ESP to the mix, we have now also introduced semantics, and the concept of the Semantic Web into the world of Enterprise Content Management.  This is why I am calling it ECM 2.0 – it is completely analogous to Web 2.0.  This is really exciting to me, all the more so because the tools to make ECM 2.0 happen are available here and now – and all built seamlessly to work with MOSS and Office 2007.  And of course, for the ultimate in legacy migration, we can set up services to pull in legacy content, analyze and ‘X-ray’ it and enrich it with metadata, break it into re-usable topics, and pull it all into the Intelligent Content Framework.

I do not mean to trivialize the effort required to get us there.  But we can get there – and we will!  Fact of the matter is that current approaches to ECM in Big Pharma are broken – the ‘Digital Scriptorium’ model of manually creating content on the Desktop, managing it in an ECM system, and cutting and pasting with no control of source and target is no longer viable.  It actually never was viable, but there was nothing better available for a long time, and companies could afford to throw money and bodies at the problem.  Those days are gone, and they are not coming back.  Flexible and innovative business models and approaches are the only alternative!

Update June 8, 2011: It was just announced that Microsoft is acquiring Prodiance Corporation, a leader in Enterprise Risk Management  This is definitely very exciting news, and a huge step in the area of Compliance and support for e-Discovery.  We also recently released a very relevant article on Technet: Microsoft IT Uses File Classification Infrastructure to Help Secure Personally Identifiable Information.  We are definitely ramping up the Compliance capabilities of our stack!

Introducing the Intelligent Content Framework (ICF)

The Intelligent Content Framework (ICF) has been a passion of mine for a long time.  It all started about 6 years ago, when my friend Gerald Kukko and I attended a Life Sciences conference in DC, and after the conference we went down for a stroll by the Potomac.  We got into a deep discussion about eCTD and the XML backbone, and Gerald made the following bold statement ‘I don’t understand publishing’ (of course, this was a ‘loaded’ statement, since Gerald is one of the smartest people I know, and I consider him a mentor – he has a way of inspiring independent thinking with quizzical responses, but few people really understand the depth of his intellect).  This statement kind of put a bug in my ear, and I started thinking in broad terms about Enterprise Content Management.  I read everything I could find on the Web about XML, SGML etc.  I came to the conclusion that most companies were taking a purist view of ECM.  The XML specialist vendors were all talking about specialized XML databases, and the traditional ECM vendors were all taking about storing content that is produced on the Desktop in their repositories because the world needed ‘better file systems’.  Then I started thinking about how this all fits together, and why we could not have the best of both worlds.  What was wrong with storing XML snippets as individual objects in an ECM system, and extracting and synching the metadata to the XML object, so the metadata became readily usable?  The main limitation of this approach was that there was a lack of an information model to supplement this.  Most traditional ECM approaches overcame this limitation via ‘chunking’ the XML documents, and storing the chunks in a so-called virtual document, so it could be assembled according to hierarchy set by the virtual document.  I was never in favor of this approach and always thought that a pure metadata-driven approach to assembling content according to business rules was the right way to go.  I also developed the view that a document was basically a collection of static and dynamic components, frozen at a particular moment in time, as part of its Life Cycle.  This goes against the face of many traditionalist approaches of producing documents on the Desktop, and managing them in a ‘better file system’.  The reality is that both ends of the spectrum need to be covered by a holistic approach to ECM.  The current reality of content production on many Regulated Industries (and in particular the Life Sciences industry, where I work) is more like a ‘Digital Scriptorium’.  I picked up this term from a long-time good customer who was head of Worldwide Regulatory Operations for one of the leading Life Sciences companies.  Whenever I think of monks sitting in a scriptorium, copying text from the Scripture, I still smile inwardly.  The mental vision exactly describes today’s reality of copying and pasting text in a digital world.  There is simply no concept of intelligent content re-use and automation. 

Fast forward a few years and a few false starts (I will not bore anyone with the details – suffice it to say that it was a good learning experience for me).  Back in late 2007, one of my Microsoft colleagues introduced me to Content Technologies who had developed a solution called DITA-Exchange.  I had done some work with their founders before, and I knew they were a bunch of great guys.  When they showed me what they had built, I was blown away.  I also immediately realized that DITA, which had become a mature open standard by now, is exactly the kind of information model that I had been looking for.  DITA has been developed for complex technical manuals and publications.  One can consider a DITA Map as a sort of a Table of Contents, which governs how information artifacts are assembled.  I then took the thinking a bit further, and started wondering why DITA could not be applied to complete documents, instead of just content fragments.  And the answer was obvious: for sure it could be applied.   So I asked my friends at Content Technologies: why can’t you create a DITA-Map of a document collection of something like an eCTD.  Two weeks later they came back with a solution. 

In parallel to the work with Content Technologies, I was also working with the DIA Document and Records Management SIAC.   Several of us within this community have been talking about the need for a industry reference model for metadata that the Life Sciences industry could adopt, instead of each company developing their own.  As the work progressed, I started thinking that what we really need is a single integrated solution that combines the DITA information model and the metadata model.  As it happens, I also started working closely with another good partner, SchemaLogic at the same time on their new MetaPoint solution for managing Enterprise Metadata across the Desktop and SharePointMetaPoint is a revolutionary product in its own right.  We teamed up with SchemaLogic to demonstrate an implementation of the new industry reference model at the 22nd DIA EDM Conference in February, 2009.  As I worked with both partners, I quickly came to the conclusion that MetaPoint and DITA-Exchange are entirely complementary products, and that an integrated solution would result in a revolutionary approach to ECM.  After all these years of thinking and planning, it came down to the simple integration of two products!  And, since both are built on a single platform, SharePoint and Office OpenXML, their integration turned out to be very straightforward.  I guess the Leonardo Da Vinci quote that my friends at Content Technologies like to use is very applicable here: “Simplicity is the ultimate sophistication”.

We realized that what we have here is an entirely new paradigm in the Enterprise Content Management industry, and so we needed to come up with a name for the integrated solution.   We decided to embrace a new name some folks have already started using in the XML Content Management: Intelligent Content, so we decided to call it the Intelligent Content Management Framework (ICF).  No doubt, Ann Rockley influenced my thinking quite a bit over the last few years, and another fundamental reading was Document Engineering by Bob Glushko.  Here is an excellent White Paper from Ann that defines her view of Intelligent Content, and here is another one by Joe Gollner that talks about Office OpenXML and DITA in the same vein.  I would call it visionary, and I share the same vision.  Here is a quote from the White Paper which brings it all together: OOXML in combination with the capabilities of DITA and collaborative workspaces fundamentally change the way organizations will handle their information. Most importantly of all, these changes are bringing the benefits of XML-enabled intelligent content to a new, and much broader, community of business stakeholders and this will energize the economics underlying the content management market.

I have uploaded some of the materials we have developed on SkyDrive over here, and the datasheet is also available from the Microsoft Life Sciences Site here: Intelligent Content Framework for Regulated Industries.

I am proud to say that we caused quite a stir at the DIA EDM Conference in February.  Our demo booth was packed most of the time, and people were quite surprised to see Microsoft get in the game with a such a high-end ECM solution.   And when it came to the ‘vendor showdown’ that the DIA organized to show the implementation of the new industry reference model, we changed the game and introduced the complete ICF vision.  Here is a direct quote from a customer after the session: “I have to say, the vendor showdown was great.  Not surprisingly, there was only ONE solution that proved it understood how content management should be.  It wasn’t even a close race.  You are doing some really exciting work.”  This kind of feedback is what makes it all worth it!

Why are we calling it a Framework?  Because a Framework needs an Intelligent Content Design (ICD) approach and the right implementation services to go along with it before we can call it a solution.  Kudos and special thanks go out to our partner and friend Jim Averback who helped adopt the vision to the Life Sciences industry, and was instrumental in developing the ICD approach.  We realized early on that technology alone is not sufficient.  Many years of experience has taught us that you can throw the best technology in the world at people, it will fail if it is not easy to use – user experience and user adoption is what can make or break the project!  Therefore, ICD will include content (taxonomy, sample content and topics, etc.)  and methodology.  Jim is already building an industry consortium of medical writers and subject matter experts who will contribute to ICD.  We also signed up a number of great Systems Integrator partners who are building an ICF practice.  It takes all these components to pull off such an ambitious and transformational endeavor!

I also want to thank Michael Brennan of Johnson & Johnson for his friendship over the years, and for sharing his vision and inspiring my thinking about ICF (and for challenging us to keep on.  Thanks also go out to Karin Schneider (‘Metadata Diva’) of J&J.

ICF is a true collaborative team effort, and is probably the most exciting solution I have worked on during my career in the ECM industry.  It is also one of the best examples I know of how SharePoint and Office OpenXML as a platform can address the needs of the most sophisticated ECM applications.

More to come – the fun has only just begun!  🙂