Oracle Business Intelligence Enteprise Edition (OBIEE) for Clinical Trial Management System (CTMS)

Oracle Siebel CRM is the base application behind Oracle’s Siebel CTMS.

Prepackaged OBIEE Applications does not have a module for Clinical Analytics and so there is a need to develop a complete custom OBI application in order to accomplish the requirements. This was untill Oracle has introduced Oracle Clinical Development Analytics (CDA) which is based on OBIEE+

Oracle CDA includes prebuilt data models, prebuilt Extract-Transform-Load programs sourcing from Oracle Clinical / Remote Data Capture and Oracle’s Siebel Clinical Trial Management System

Business Intelligence can be deployed in several Core functions

  • Protocol Design and Study Start-Up
  • Patient and Investigator Recruitment
  • Clinical Trial Management
  • Clinical Data Management
  • Data Analysis
  • Clinical Supplies
  • Regulatory and Safety

Nonclinical Use of  Business Intelligence in Clinical Trial
There are a number of ways in which business intelligence as a technology platform can be used to support the pharmaceutical value chain. There is ample evidence to show how business intelligence has been used successfully in a number of areas including:

  • Sales and Marketing
  • Manufacturing
  • Finance
  • Human Resources
  • Information Services
  • Executive and Portfolio Management

Clinical Use  of  Business Intelligence in Clinical Trial
Within clinical research, the strongest use of technology is in pre-clinical research, clinical, statistical programming and supporting other groups such as:

  • Data management (patient profiles)
  • Medical writing
  • Finance
  • Project management
  • Patient registries and post-marketing surveillance

 

Without CDA an OBIEE architect needs to understand CRM data model and also the actual business process flow of a CTMS application.It is observed that usually there is a customization to an extent of 25% on the CRM application.

Original Old Article on OBIEE for CTMS which was the only Business Intelligence solutions for Clinical trial management before Oracle announced CDA is Available at http://www.obieetalk.com

Requirements gathering sessions must be interactive with group of SME’s, Team of members from business, project sponsors to mitigate any risk of
slipping the time lines. It is recommended to plan for regular client reviews and approvals of every build to avoid any gaps in the expectations by the client .

At a high level the reporting requirements may include tracking budget and finance, clinical trials, activities, investigators,Initiations, enrollments, expiration’s, terminations. Cross dimensional hierarchies from Program to Protocol to Site to Subject is commonly desired.

Major dimension tables specific to CTMS includes Program, Protocol,Site,Subject, application, Investigator. Other common dimensions include Accounts, Contacts, Activities, Time, Geography,product, etc.

Here is a screen shot of a sample rpd for CTMS

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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

Indian Healthcare IT market & Oracle’s presence in Indian Healthcare

Dr. Mehdi Khalid Vice President, Healthcare and Life Sciences Industry Business Unit Asia Pacific and Japan at Oracle about key aspects of healthcare IT market in India & Oracle’s presence in this space.

DownloadHealth India 2010

Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs

The Institute is focused on research that will accelerate IT innovation to advance personalized medicine and the delivery of safe and effective   treatments and health care services to patients around the globe. OHSI will work in tandem with academic research centers, focusing on a targeted set of research areas fundamental to the R&D and health care delivery challenges facing health sciences organizations today. Research priorities currently include: artificial intelligence and semantic technology; genomic, genetic and phenotypic data analysis; data mining to support optimization of clinical trials; and predictive algorithms and other technology to advance patient safety and provide advanced decision support at the point of care.Academic institutions interested in collaborating with OHSI in these focus areas should contact OHSI representatives at Oracle http://linkd.in/bXf98c
Oracle starts Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs. This is exiting news and I hope we get to see the participation of Open Source Drug Development Network (OSDD) and initiative by CSIR India earlier supported by Sun Microsystems

Linkedin and Social Media is ruining my people- feeble attempts to fight of Social Media and the Compliance nightmare

There has been a flurry of discussion around social media and its implication in the last few  months , So I thought it would be good to have some of these arguments laid out in one single post. Social Media has entered every business and industry even, inside the US Intelligence Community, who sorted out their knowledge-sharing problem and a problem with locating expertise—throughout the  bureaucracy of 16 federal agencies—using  simple tools like an intelligence community–wide Wiki and blogging environments among other things

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Social Media and Sales

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: that usual rhetoric many sales managers would say now a days.   Does Social Networking help sales people sell I liked that statement especially since it came from Microsoft executive.  As I have also faced the ire of top management for using social media in my career, . So this report is an eye opener for opponents of social media for sales. Read the Full Article.

LinkedIn insiders know that you can use the site’s information for more than job, sales, and partnering leads – you can find out what others are up to as well. There are downside to using Linkedin last fall an Apple employee revealed that he was managing a team developing a new chip for the iPhone while the information was still secret. . So be careful LinkedIn or any other social tools can bite you back if not used properly.

I would partly agree to the argument that social media and internet created a lot of distractions, but I dont think this is something new, we had distractions in our daily life and in office environments even before theadvent of internet. the only difference now it is easier not to do your job and indulge in something else while you are supposed to be at work when in office.

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Social Media and Influence on Decision Making

Second on my reading list was the study conducted by Don Bulmer (Vice President Global Communications- SAP ) with Society for New Communications Research. Take a look at this in his blogpost  at Social Media’s Impact on Business and Decision Making Everyday Influence blog .  Result of the study concludes that Top execs  are influenced by social networks . The copy of the report is on SNRC website

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Social Media Investments

Third on the reading list was a New Study from Deloitte, Beeline Labs and the Society for New Communications Research Indicates Despite the Recession, 94 Percent of Enterprises Continue to Invest in Online Communities & Social Media  Full Article

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Then there was  presentation by Steven Tylock, on Social networking meets sales , the presentation is on  Microsoft website

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Compliance and Social Media

The Society of Corporate Compliance and Ethics and the Health Care Compliance Association conducted a survey among compliance and ethics professionals in late August 2009 to see what employers are doing about the use of these sites by their employees.

They got back almost 800 responses from their members using an online survey tool.

  • 50% of respondents reported that their company does not have a policy for employee online activity outside of the workplace
  • Of those companies that do have a policy, 34% include it in a general policy on online usage
  • Of those companies that do have a policy, just 10% specifically address the use of social network sites

It would be interesting to see How companies are going to include a clause on their information protection and compliance rules to define what information an employee can add to his linkedin profile during or after his tenure with the organization, especially information related to projects.

For example When an IA rep uses Twitter to send a link to an article from an online magazine, newspaper, or other site to clients and prospects “following” him, that communication is subject to SEC advertising rules. However, Bernstein says that merely sending a link is not advertising—as long as you don’t give your opinion.

A “recommendation” on your Linkedin profile by a client does indeed constitute a testimonial and, thus, violates SEC rules prohibiting RIAs from using client testimonials in advertising.

The SEC will be busy in coming months addressing the many issues posed by advisor use of social media. FDA has already release its framework on use of social media in Drug Marketing.

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Drugs, Heallthcare, FDA and Social Media

The FDA is currently considering how to handle social media, such as SideWiki, Facebook, etc. Companies such as Google, Sermo, and Twitter are playing an increasing role in marketing products to consumers and healthcare professionals, whether our customers like it or not. Technology and Life Sciences companies are pushing the FDA to come up with standards and templates. The following article has some great links to presentations from PhRMA, Google, and even from Pfizer’s Chief Medical Officer.  

Read about Googles pitch to FDA for online Drug Advertisements from the wall street journal

An archived webcast and other details of the FDA  Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools is available at the FDA website

Here what emerged from this hearing

FDA explained in the Federal Register notice that “entities should review any Internet sites sponsored by them for Drug Adverse Event Information, but are not responsible for reviewing any Internet sites that they do not sponsor; however, if they become aware of an Adverse Drug Event on an Internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.”

Numerous speakers stated that drug manufacturers are hesitant to fully engage in online social media specifically because they want to avoid learning about potential AEs and the resulting reporting obligations, particularly because the guidance in this area is unclear

Pending further guidance, companies should prepare for further FDA scrutiny of this area by developing compliance
policies to address the challenges of involvement in Internet and social media tools, including but not limited to:

„„policies relating to employee involvement in social media, and in particular statements regarding company products;

„„company involvement in physician and patient-focused social media, including both company-sponsored sites and third-party sites run by third-party organizations (and particularly those receiving manufacturer support through grants or other funding);

„„addressing the challenge of Sidewiki and similar functions that make third-party generated information directly available in conjunction with company websites;

„„updating promotional review policies to ensure consistency with developing FDA approaches to risk communication on the Internet, including sponsored links;

„„policies regarding statements that company-affiliated parties (e.g., investigators, patients) may make on the Internet, which may constitute endorsements or testimonials requiring both review and specific disclosures; and

„„ensuring a consistent and compliant approach to pharmacovigilance with respect to Internet-reported adverse events of Drugs.

 

I know one company that provides  Content Monitoring, Control & Recording across Web 2.0; User Behavior Reporting over Multiple Modalities, Regulatory Compliance for management and security of Web 2.0 applications such as social networking, blogs, wikis, webmail and social networking sites such as Twitter, Facebook and YouTube instant messaging, and Unified Communications. But at a cost of $9,200, it would be out of reach for individual and SMEs.  Still have a look at the recent press release by factime on its FaceTime’s Unified Security Gateway

Data Management and Integration for the Future of Clinical Trials webcast

Upcoming Webcast: Data Management and Integration for the Future of Clinical Trials

Attend this interactive webcast presented by Applied Clinical Trials and Oracle Health Sciences featuring speaker Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research and Claire Castaings, Vice President Worldwide Director, Clinical Data Management Sanofi-Aventis. This session examines the use of the latest electronic data capture technology to efficiently integrate critical data sources.

Webcast Details

Speakers:
Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research
Claire Castaings, Vice President Worldwide Director, Clinical Data Management, Sanofi-Aventis

Live webcast date and time: November 10, 2009 at 8:00 AM PT/11:00 AM EST

To register for this event, click here.

The integration of data from the various technologies employed in clinical trials continues to increase in complexity. The typical clinical trial today integrates data from IVR, EDC, ePRO & Laboratories, to name but a few. Achieving a seamless integration of data greatly improves the speed at which data is available, enhances the quality and consistency of that data, and reduces costs. The pharmaceutical industry continues to strive for this efficiency while reducing the cost of getting drugs to market. Outsourcing drug development to CRO’s using the latest technology platforms is a key strategy in this quest. This webcast will explore how a leading pharmaceutical company and ICON used the latest electronic data capture technology to efficiently integrate all critical data sources, ultimately enabling the continuous assessment of patient data.

In this webcast you will learn how to:

  • Have a deeper understanding of ways in which technologies can interface to integrate data
  • Understand how time savings were achieved in the provision of data to monitoring committees
  • Realize the benefits of working together where activities are outsourced and how the latest technologies can derive benefit

Register today for this thought-leading event!

Multi National Pharma sell their Captive Clinical Research Facilities in India

MNC pharma companies to control 8% of $20bn worth Indian medicines market by 2015. According to a FICCI study more than 60% of trials in India is conducted by Global Big Pharma companies.  Indian Clinical Research arena is often compared to the Indian outsourcing success and hte wave of BPO industry success in India.

Multi national companies that launched their own captive BPO centres India have now sold them to Indian vendors,  that trend has grown, the likes of , GE, Citi Bank, all have sold their captive centres to Indian vendors

In curent wave or Indian CRO success in clinical research is compared to such trends. There may be a possiblity that the likes of Novartis, Pfizer, Lilly, Sanofi, GSK can sell their captive centres that focus on clinical research to Indian CRO’s.

But for the time being such ambitions by Indian CRO will remain as pipe dream untill they will move  away from “I can do it cheaper and faster than in west”- sales pitch. And gains credibility and resources to offer value added service to Global Pharma

For example Indian CRO can offer backend integration with Indian Medicinal chemistry experts and companies to provide drug re-licencing /re-positioning services. They need to think about offering these value add services. Following are some of the areas Indian CRO’s can look

1. what happens to failed Clinical Trial and how can Indian CRO help Global Pharma to Drug repositioning/Re-profiling of drugs

2. How can Indian CRO provide Pharmacogenomics  services with clinical trial

3. How can Indian CRO help in personalized medicine initiatives

4. Even though it serves the vested interests of Global Pharma how can Indian CRO help in Extending patents of existing drugs with ANDA and NDDS

5. Pharmacovigilance and Post -Market Surveillance for Risk Assesement and Risk Mitigation

6. Data Warehousing and Data Mining by integrating clinical and non clinical data from multiple studies

7. Drug Life cycle management services

8. Generating Key opinion leaders and KOL platform by using data from multiple trials and resources

9. Premarketing Clinical Drug Safety and Risk Assessment

10. Designing Pharmacoepidemiology and Pharmacoecconomics stratgey and Aiding Evidence based pharmacotherapy


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