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

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

Life Sciences at Oracle Open World 2010

Learn more about the strategic dynamics of Life Sciences at Oracle Open World 2010, from September 19-23. Attend the Life Sciences track to learn how Oracle’s powerful combination of technology and comprehensive business applications can help you address key challenges such as costly, high-risk discovery periods and shrinking patent expiration limits.
Leading life sciences organizations will discuss how they are moving toward modernizing their
business process, architecture, and technology infrastructure in an attempt to address the challenges faced by the industry today. Find out more and register here: http://bit.ly/a1thgy

The The Evolving Role Of Pharmacovigilance a discussion with John Loucks, VP of Oracle Health

To gain an understanding of the current state of pharmacovigilance in the industry, Life Science Leader spoke with Sujith Eramangalath, the senior analyst in medical imaging, healthcare IT, and life sciences IT at Frost & Sullivan; Drew Kilpatrick, Ph.D., director of global safety and pharmacovigilance at Kendle; John Loucks, VP of Oracle Health Sciences; Nayan Nanavati, M.S., M.T., VP and general manager, peri- and post-approval research and worldwide head of pharmacovigilance at PAREXEL; and Charles Saldarini, CEO of Sentrx.

The Original Article published at Life Science Leader http://tinyurl.com/yzbqubv

Oracle Openworld 2007- Personalized Genomics session

Its the time -Personalized Genomics

Advances in genetic information and laboratory technologies mean new ways to diagnose disease and determine patient risk. The wealth of genetic information makes it harder to provide meaningful information. During Oracle OpenWorld 2007 Oracle is presenting how laboratory information systems principles and Oracle customer relationship management and enterprise resource planning applications weave together, using Oracle Fusion Middleware to create a unique platform for translational medicine.


Click here to register now.

Oracle OpenWorld

Experience Innovation. November 11-15, 2007, San Francisco, Moscone Center.

As the Life Sciences industry continues to grow and change, Oracle is there to help you learn, adapt, and succeed.

Please join us this fall in San Francisco as we address some of the biggest challenges facing the Life Sciences industry and how Oracle is prepared to meet those challenges.

Session highlights include:

  • Product Lifecycle Management—At this session, learn how Oracle’s Agile product lifecycle management solutions for Life Sciences improve new product introduction cycle times, reduce direct material and operating costs, and enable cost-effective compliance.
  • A Cure for Clinical Trials: From Data Capture to Submission—Approximately 80,000 clinical trials are being conducted in the United States at any given time. More than half of them are behind schedule by one to six months. Clinical trial sponsors hope to reduce this and other costly delays through the use of IT. Hear how the latest enhancements in Oracle’s industry-leading Life Sciences applications are streamlining the process of data capture, management, analysis, and reporting.
  • Enabling Personalized Medicine in Research and Development—The sequencing of the human genome is yielding exciting new tools to help physicians tailor treatments to individuals and their diseases. This powerful new capability, called personalized medicine, holds great potential to improve patient health. Learn how Oracle’s technology is enabling personalized medicine and improving efficiencies and outcomes in clinical development.

Click here for a full list of Life Sciences sessions.

Registration is now open for the most exciting technology and business conference of the year.
Registration fees go up soon So don’t wait—act now to save $900.

Click here to register now. To receive your special discount, select a registration category and enter keyword: ORF at the bottom of step 2 of the registration process.

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Scholarly publishers throws out Microsoft

After PLOS nature its the turn of microsoft, Life science researchers are in no mood to relent to industry’s interests.

Microsoft’s latest Word release has caused chaos in scholarly publishing circles. Submit a paper to, the journal Nature in Word 2007, and you will face the following warning:

We currently cannot accept files saved in Microsoft Office 2007 formats. Equations and special characters cannot be edited and are incompatible with Nature’s own editing and typesetting programs.’

And it’s not just Nature. Try Science, The Lancet and pretty much any ‘mathematics-intensive’ journal in the world and you will hit the same problem

Science and Nature will no longer accept manuscripts written in Microsoft’s Office 2007 suite. because the latest version of Word is no longer compatible with Mathematical Markup Language (MathML), the de facto standard for writing equations in text documents, according to recent notices posted on the Web sites of both Science and Nature journals. In Office 2007, Microsoft’s own Office MathML (OMML) is used for equations.

And it doesnt end there Microsoft and Sun and open world society are up in arms against each other on adoption of Open Source Document Format. Microsoft supports OOXML and Sun supports ODF (Open Document Format alliance)  which also is enjoying widespread support from academia and corporates like Oracle, IBM, Red Hat, Sun Microsystems, Google

India’s  21-member technical committee decided that India will vote a ‘no’ against Microsoft’s Open Office Extensible Mark Up Language (OOXML) standard at the International Standards Organisation (ISO) in Geneva on September 2.

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