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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