Case Study: Providing Full Support Services to a Small Biotech Organization
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This document discusses a case study of C3i providing a full suite of clinical technology services to a small biotech company called XBiotech. C3i implemented an integrated solution using Oracle Clinical, Oracle Remote Data Capture, and other applications to provide hosting, training, support, data management and other services. This allowed XBiotech to focus on their clinical operations and drug development while leveraging C3i's expertise and infrastructure. The solution was beneficial for both companies as it allowed for growth potential and minimized risk for XBiotech through an optimized turnkey solution.
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Case Study: Providing Full Support Services to a Small Biotech Organization
- 1. Case Study - Providing a Full Suite of Clinical Technology Services to a Small Biotech Company Kevin F. Shea Senior Solutions Architect kshea@c3i-inc.com
- 2. Agenda » Objectives » Background » Key Drivers » Solution Overview » Lessons Learned » Conclusions 2 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 3. Objectives » Describe the challenges faced by a small growing biotechnology company » Discuss the benefits a turnkey solution can provide » Review lessons learned 3 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 4. Background » XBiotech – Austin, TX based biotherapeutic company Ÿ One study completed Ÿ Aggressive schedule of forthcoming trials Ÿ Multiple therapeutic areas Ÿ Limited personnel » C3i Ÿ Provider of Clinical Services Ÿ Oracle Partner Ÿ BPO participant Ÿ New solution offering 4 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 5. Key Drivers » Cost » Efficiency » Expertise » User Support » Training » GxP/Regulatory Compliance » Data Management » Information Technology 5 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 6. Solution Overview 6 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc. Oracle Clinical DATA DISCREPANCIES Clinician Monitor Oracle Remote Data Capture Investigator DATA COLLECTION APPROVE REVIEW/VERIFY Oracle Clinical Oracle Clinical DATA DISCREPANCIES Clinician Monitor Oracle Remote Data Capture Investigator DATA COLLECTION APPROVE REVIEW/VERIFY Clinician Monitor Oracle Remote Data Capture Investigator DATA COLLECTION APPROVE REVIEW/VERIFY OC/RDC/TMS & JReview Hosting Site, PI, Sponsor Training Multi-lingual 7x24 HelpDesk Support Study Close Out Study Dev & Mng Site Assessments Tier 2 & 3 Technical Support User Account Administration Benefits ü Ease of entry & lower up-front investment ü Grows and adapts as clients add more studies ü Simple: software delivered as a service ü No infrastructure ü Automatic upgrades
- 7. Data Center Hosting/Managed Services » System hosting for OC/RDC in fully compliant data centers » Scheduled/Controlled upgrades » DBA Services with Backup and Disaster Recovery » Access to leading technology and best-in-class applications that deliver maximum business value 7 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 8. Licensing » OC/RDC/TMS Business Processes Outsourcing Ÿ Benefits of perennial software licensing with the convenience of a service Ÿ Ease of entry & lower up-front investment Ÿ Grows and adapts as clients add more studies Ÿ No infrastructure Ÿ Automatic upgrades » JReview Admin and Read-only User Ÿ Short-term license structure Ÿ Flexible 8 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 9. Training » Delivered instructor-led RDC OnSite live over the Internet Ÿ PI-specific training Ÿ SITE-specific training » Task-based user training for all associated internal roles in CDM, ClinOps, Validation and QA 9 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 10. Support » 24x7 HelpDesk support in five languages » Tier 2 – Application Technical Support » Tier 3 – System Technical Support » Integrated support model provides all levels with integrated escalation paths » Directly manages resolution of Oracle Service Requests (SRs) » Client-specific knowledge objects 10 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 11. Data Management Services » Study design support from staff augmentation to full partnership, study design and on-study management ops » Industry best practices ensure that your protocol is designed to meet endpoints, utilizing OC/RDC » Study is created and validated to ensure proper data collection and compliant reporting » Full study design process supported by Quality Mgt system that minimizes audit-risk 11 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 12. Lessons Learned » Integrated solution provides real benefit to small organizations » Single vendor provides: Ÿ One point of contact Ÿ Enhanced cooperation Ÿ Deep understanding of client’s processes, strengths, weaknesses Ÿ Advantageous economics » Growth potential for client and vendor 12 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 13. Conclusions » Small, start-up organizations focused on ClinOps and MedAffairs of the clinical trial » Many are challenged to extend capabilities and infrastructure to build and manage a top-level CDMS » Dedicated third-party clinical services company can provide: Ÿ Hosting and subscription-based licensing Ÿ Logistics Ÿ Data management Ÿ Training Ÿ Support » The combination of organizations and expertise minimizes risk and optimizes results 13 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 14. Biography Kevin F. Shea Senior Clinical Solutions Director +1 610-772-5726 kshea@c3i-inc.com » Kevin has been involved in the Pharmaceutical/Life Science industry for eleven years, with an emphasis on creating solutions utilizing clinical technology for to enhance clinical trials. He has expertise in Oracle Life Sciences application solutions, particularly Oracle Clinical, Oracle RDC, Oracle TMS, and Siebel Clinical. At C3i, Kevin manages clients, delivers clinical services incorporating hosting, managed services, training, support, clinical data management and clinical operations. » 14 August 15, 2013© 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.