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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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

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

 

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.

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!

How should you safely outsource pharmacovigilance to an Indian contract research organization?

Published in hte Indian Journal of Pharmacology. Edwards B. How should you safely outsource pharmacovigilance to an Indian contract research organization?. Indian J Pharmacol 2008;40:24-7

The articles focus on different types of CRO that operate in India and the concerns western companies should address before deciding to oursource the trial to Indian companies.

exerpts from the article

The heterogeneous concept of a Contract Research Organization (CRO) in India is that, a CRO might refer to independent locally owned CROs, an affiliate of a multinational CRO, one owned by a larger non-healthcare companies (such as an IT company wanting to move into pharmaceuticals), one owned by a healthcare or pharmaceutical company or a hybrid of a CRO and a site management organization. In addition, there are significant differences in costs and capabilities. Only a small number have experience in multinational Phase II and III studies sponsored by US or EU companies. Costs for CRO services can vary by as much as fivefold. For instance, the cost per monitoring visit can vary between $400 and $2500 per visit. Employee turnover can be as high as 60% (a healthy number in a Western CRO might be approximately 10-20%); 95% or more of investigators meet recruitment goals. However, although for US studies query rate are typically 10-20%, the rate rarely exceeds 5%. Thus, there is no cohesive business strategy to develop the Indian pharmaceutical sector with enormous amount of variations in existing CROs.

Sponsors should be aware that high rates of staff attrition and turnover study monitors may well impact a CROs’ safety capability. Previously training in pharmacovigilance and GCP is a major issue with very few training courses in India, resulting in not enough GCP and pharmacovigilance trained personnel. The consequence of these factors may lead to the more experienced sites becoming overloaded with projects and the better investigators conducting proportionately more trials. In addition, the more attractive sites for recruitment may indicate that medical investigators already have a high patient load for their normal clinical practice, squeezing time for research subjects. This point is critical because of the challenge of informed consent from illiterate patients as described in a BBC documentary. Thus, it is critical the CRO industry rises to the Quality challenge by building quality as an integral part of all processes. This indicates that recognizing the costs of quality control and quality assurance checks are essential, not just an overhead.

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