Managing Global Studies with Oracle's Siebel Clinical Trial Management System (CTMS)
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The document discusses how clinical trials are increasingly being conducted globally to reduce costs. It presents three case studies of companies using Oracle's Siebel Clinical Trial Management System (CTMS) to manage global studies. Key challenges include communication across countries, varying regulatory requirements, and financial management in different currencies. Siebel CTMS addresses these through features like multi-language support, customizable templates for documents and activities, and currency conversions. The presentation concludes with a demo of Siebel CTMS and a Q&A section.
Managing Global Studies with Oracle's Siebel Clinical Trial Management System (CTMS)
- 1. Managing Global Studies with Siebel CTMS August 29, 2013 Parambir Singh Vice President of Clinical Trial Management Solutions BioPharm Systems
- 2. Welcome & Introductions Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. • CTMS practice head since 2007 – Expertise in managing all phases and styles of clinical trials – Leads the team that implements, supports, enhances, and integrates Oracle’s Siebel Clinical solution • Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical – 30+ implementations and integrations – Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel Clinical psingh@biopharm.com | (210) 454-5192
- 3. Welcome & Introductions (cont.) CTMS Practice Services Implementations Manage implementations of Siebel Clinical vanilla and BioPharm’s Siebel Clinical accelerator, ASCEND. Integrations Build one- and two-way interfaces between Siebel Clinical and other clinical and non-clinical systems. Training Develop and/or deliver standard and custom training classes and materials, including Siebel iHelp. Process Guidance Provide insight, advice, and solutions to specific clinical trial management issues.
- 4. Agenda • Industry Trend Toward Global Clinical Trials • Challenges Inherent in that Trend • Case Studies of Clients Using Siebel CTMS to Manage Global Studies • Additional Siebel CTMS Capabilities That Can Help • Demo of Relevant Siebel CTMS Functions • Summary • Q&A
- 5. Industry Trend Toward Global Clinical Trials • Continuing pressure to reduce costs and shorten drug development timelines, exacerbated by: – Several patents expiring between 2011-2014, meaning increased competition from generics – Shrinking drug pipeline, based on a reduction of FDA approvals for New Molecular Entities (NMEs) over the past several years • Life sciences organizations in developed markets are realizing the potential in conducting trails in emerging market countries
- 6. Industry Trend Toward Global Clinical Trials (cont) • Since 2002, number of FDA regulated investigators based outside of US has grown by 15% annually – Number of investigators in US has declined by 5.5% • In Nov 2007, ClinicalTrails.gov reported that of the 20 largest US based companies, over 30% studies registered are being conducted solely outside of the US
- 7. Industry Trend Toward Global Clinical Trials (cont) • Most rapid growth: Latin America, Eastern Europe and Asia – FDA-regulated clinical trials primarily for confirmatory, later stage studies • Steady growth in emerging regions is due to many factors including: – Lower relative study conduct costs – Harmonization of good clinical practice guidelines – Well-positioned contract research organizations – Availability of well-trained professionals and treatment-naive patients
- 8. Challenges In Global Studies 1. Communication with study and site teams 2. Adherence to regional and country-specific regulatory requirements 3. Tracking payments in multiple currencies 4. Selecting the best non-local vendors
- 9. 1. Communication • Language and terminology differences • Cultural differences • Time-zone differences “ Standardizing terminology in our industry across the global organization was a difficult task without a centralized system” “ Understanding cultural differences in each region and country is key to developing accurate estimates for work to be conducted in that area”
- 10. 2. Regulatory Requirements • Regional documentation requirements • Regional regulatory submissions • Regional patient advocacy and privacy concerns “Each country has its own regulatory documentation and submission requirements. Ensuring that the we are in compliance with all regional requirements is a large undertaking.” “Different IRB/IEC approval processes & requirements. Different data retention requirements. Different internal trial approval process within the company. May use different document trial tracking systems. “
- 11. 3. Financials • Tracking site and vendor payments in foreign currency • Drawing contracts to reflect exchange rate • Managing exchange rates for multiple regions
- 12. 4. Investigator and Vendor Selection • Finding appropriate high performing Investigators in emerging markets • Finding and managing activities of service provider vendors globally
- 13. Client Case Studies • Identified our current clients who are using Siebel CTMS to manage global studies • Interviewed them about the nature of their trials, as well as the features of Siebel CTMS that they are using to support those trials • Selected 3 case studies to share with you today
- 14. Case Study #1 • Type of company: Device • Characteristics of “typical” global study – Number countries: 24 – Number of sites per country: 1-30 – Number of subjects per site: 10-300 – Countries used: Belgium, Poland, Denmark, France, Italy, Poland, Spain, Switzerland, UK, USA
- 15. Case Study #1 (cont) • Using Siebel CTMS for global studies since: Sept 2009 • Features used: Activity/Document Templates • Biggest Insight: “We create the regulatory templates not around each country specifically, but around the most rigorous regulatory requirements. For example – IDE Study + EU and American requirements. If certain documents are not needed, use N/A.”
- 16. Case Study #2 • Type of company: Biopharmaceutical • Characteristics of “typical” global study – Number countries: 30-50 – Number of sites per country: 6-10 – Number of subjects per site: {not provided} – Countries used: Brazil, UK, Canada, Germany, France, Argentina, Netherlands, Spain, Czech Republic, Israel, Italy, Taiwan, China, Australia, Poland, Romania, Mexico, Austria, Belgium, New Zealand, Russian Federation, Korea, Sweden, Hungary, Turkey, Portugal, Hong Kong, Singapore
- 17. Case Study #2 (cont) • Using Siebel CTMS for global studies since: May 2011 • Features used: Currency Conversions • Biggest insight: “Site payment information is integrated from our CROs. The site payment information that is integrated from the CRO is in the local currency.”
- 18. Case Study #3 • Type of company: Medical Device • Characteristics of “typical” global study – Number countries: 3 – Number of sites per country: 1-5 – Number of subjects per site: 20 – Countries used: USA, Italy, Germany
- 19. Case Study #3 (cont) • Using Siebel CTMS for global studies since: March 2012 • Features used: Activity/Document Templates, Currency Conversions (planned) • Biggest Insight: “It’s very useful for meeting different global document tracking requirements, different study milestones across the global studies, and all levels of study information, etc. The template customization makes managing the global studies easier.”
- 20. Additional Relevant Siebel CTMS Functions • Communication – Capabilities for multi-language support for UI and Reports – Support for special character languages and Unicode • Regulatory Requirements – Capabilities to enable region/country-specific templates for documents and activities • Financials – Support for tracking multiple currencies within and across studies – Currency conversions enabled for study and program level aggregations
- 21. Additional Relevant Siebel CTMS Functions (cont) • Investigator and Vendor Selection – Record useful qualities of potential investigators/vendors, such as: • Technology and equipment at their facility (wireless Internet, sub-zero refrigerators, on site lab, on site pharmacy) • Types and depth of experience • Patient population(s) to which they have access • Languages spoken fluently – Track performance of investigators and vendors – Select high performing investigators and vendors with the qualities you need for future trials
- 22. Siebel CTMS Demo
- 24. Summary • Clear trend toward running clinical trials in multiple countries, despite the inherent challenges • Companies like yours are using Siebel CTMS to manage global studies; however, several of Siebel’s useful features for managing such trials are being under-utilized • Siebel CTMS can be used to address communication, regulatory, financial, and investigator/vendor challenges through the use of: – Multiple languages – Intelligently designed activity/document templates – Currency conversions – Contact/Account “categories,” “assessments,” and targeted site selection
- 25. Q&A
- 26. Contact Us • North America Sales Contact: – Rod Roderick – rroderick@biopharm.com – +1 877 654 0033 • Europe/Middle East/Africa Sales Contact: – Rudolf Coetzee – rcoetzee@biopharm.com – +44 (0) 1865 910200 • General Inquiries: – info@biopharm.com