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:

• 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

collaborative clinical trials management software for Central Laboratories

Laboratory Corporation of America Holdings…announced…a collaboration between Esoterix Clinical Trials Services, a division of LabCorp, and Clearstone Central Laboratories, a global central laboratory specializing in drug development and pharmaceutical services.…The collaboration provides LabCorp with access to Clearstone’s global network of labs, including China, France, Singapore and Canada, in addition to LabCorp’s existing labs in the United States and Belgium. The companies will collaborate on providing standardized central laboratory testing for clinical trials to their respective clients. The transaction also provides LabCorp access to Clearstone’s clinical trials management system APOLLO CLPM clinical trials management software, enhancing the ability of clients to conveniently send, receive and manage data.

APOLLO CLPM is a secured globally accessible web based, 21 CFR part 11 validated clinical trials management software. Designed and developed by subject matter experts of every applied discipline integral to the system. Built on an Oracle database, the APOLLO CLPM system is a truly singular database that replaces multiple legacy systems and sub-systems, helping to drive improvements in efficiency and quality across the central laboratory business Apollo provides for global standardization of requisitions, reports, kits, barcode labels, as well as scientific information, and improves the accuracy and speed of sample reception and processing

SalesForce.com partner introduces CRM for clinical trial management on Force Platform

Had an interesting chat with the CEO of the US based IT service provider for clinical research industry in June. Apparently the company a SalesForce.com partner introduces new CTMS application in India. Just came to know that they are going commercial this month. The applications is aimed at clinical trial management, Study site management and Patient Recruitment in the clinical research industry . Aimed at CROs, Hospitals, University Research centers and clinical trial Study Sites.

The application is based on Force platform by SalesForce and already have few Indian Organization using it for several months. The product will be offered in SaaS/Hosted/Cloud versions, which will render affordable TCO and higher ROI with less or no Capital investmental.

Site Coordinator’s Role in Clinical Trials Success

Industry Standard Research (ISR) today announced the launch of a new and substantial research report titled “The Voice of the Site Coordinator.” This report presents data and analysis from 124 interviews with Study / Site Coordinators from the US, Europe, Latin America, and Asia.

Kevin Olson, CEO, Industry Standard Research. Olson says “Our data suggest that directly engaging a site’s coordinator is likely to yield both faster recruitment and higher quality data.”

The report provides a detailed analysis of coordinators’ responsibilities; coordinators’ critical perspectives on improving the accuracy of feasibility estimates; and their insights into current patient recruitment practices and how to meaningfully improve them. The report even profiles sites’ uses of – and preferences for – different eDC and ePRO technologies.

“Drug development professionals are forever looking for ways to strengthen their partnerships with sites, and for good reason.

 

UK’s Medical Research Council grants Clinical Research consortium $6.4 million to develop chips & software to use mobile phones/PCs as testing devices for sexually transmitted disease (STD)

UK’s Medical Research Council grants a Clinical Research consortium $6.4 million to develop chips & software to use mobile phones/PCs as testing devices for sexually transmitted disease (STD)

If successful individuals will drop their blood, urine or saliva on a mobile chip, which they then insert into a mobile phone or PC. Software on the phone or PC then delivers a diagnosis, schedules a clinic appointment or sends an electronic prescription to a pharmacy. Consumers will be able to purchase the chips in vending machines or at a local pharmacy

Insurance coverage for healthcare IT software, to protect healthcare IT companies from damages inflicted by their software

Ah. well they should be protected, with the number of physicians unhappy with the Healthcare IT systems rising. We ll thank goodness patients will also get third party coverage if the software errs.

Chubb Group of Insurance Companies has established the “Healthcare Information Technology” liability insurance to protect Healthcare IT companies.

Over 1,000 companies supply information technology products and services to the healthcare and medical research industries in the US and Canada would be happy to hear that

An integrated liability solution from Chubb can help protect healthcare information technology companies from:

• general and products liability when software or hardware that is defective or contains inaccurate or incomplete information causes or contributes to patient injuries;
• errors and omission liability when a product defect or service deficiency results in economic injury to a customer;
• third-party liability to patients, healthcare providers and others associated with database security breaches; and
• costs incurred to comply with state, federal

Chubb is targeting Healthcare Information Technology Companies providing any of the following services

• Electronic health record system providers
• Clinical decision support system providers
• Telehealth and health information exchanges
• Practice management system providers
• Payor system providers
• Drug discovery firms
• Clinical informatics firms
• Healthcare systems consulting firms

 

22 Million Australian Cloud computing initiative to benefit life science researchers

The Australian Research Collaboration Service (ARCS) www.arcs.org.au has launched its Computer Cloud scheme, a $22 million project funded by the government’s National Collaborative Research Infrastructure Strategy.

More details check http://www.arcs.org.au/index.php/services/cloud-computing

Bob Correll, the chief information officer for the Department of Immigration and Citizenship, said his agency is also looking into using cloud computing for its electronic visa system

GSK, MedTrust launch iPhone/iPad app for cancer trials

GlaxoSmithKline has teamed up with MedTrust Online,  provider of specialist data and technology to oncologists, to launch CancerTrialsApp, described as “the first free geo locating cancer clinical trials application” for the Apple iPhone and iPad.

The application enables cancer doctors to find and share with their patients information about experimental therapies in clinical trials

National Library of Medicine wants health care organizations to test drive Medical mapping tool

The National Library of Medicine wants health care organizations and vendors to test drive its new mapping tool that covers 5,000 standardized clinical terms , to create a standard medical vocabulary to support applications for electronic health records

The Obama administration is distributing more than $19 billion in payments to doctors and hospitals that buy and use digital record systems for patients.

The library released a draft mapping tool that links terms from the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) to the International Classification of Diseases, Ninth Revision (ICD-9). The SNOMED-CT is the terminology used for clinical purposes, while the ICD-9 has terms used for billing and administrative support.

The map was designed with help from SNOMED-CT terms most often used by Kaiser Permanente and the University of Nebraska, to support semi-automated administrative reporting and reimbursement for health care services.

The library wants users to “test drive”’ the map from Dec. 1 through Feb. 1, 2010, and to provide feedback to guide developing related maps. The related maps include mapping of SNOMED-CT to the ICD-Tenth revision, Clinical Modification and Procedure Coding System.