case study: providing full support services to a small biotech organization
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TRANSCRIPT
Case Study - Providing a Full Suite of Clinical Technology Services to a Small Biotech Company
Kevin F. Shea Senior Solutions Architect [email protected]
Agenda
» Objectives
» Background
» Key Drivers
» Solution Overview
» Lessons Learned
» Conclusions
2 August 15, 2013 © 2010 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Objectives
» Describe the challenges faced by a small growing biotechnology company
» Discuss the benefits a turnkey solution can provide
» Review lessons learned
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Background
» XBiotech – Austin, TX based biotherapeutic company � One study completed
� Aggressive schedule of forthcoming trials
� Multiple therapeutic areas
� Limited personnel
» C3i � Provider of Clinical Services
� Oracle Partner
� BPO participant
� New solution offering
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Key Drivers
» Cost
» Efficiency
» Expertise
» User Support
» Training
» GxP/Regulatory Compliance
» Data Management
» Information Technology
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Solution Overview
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Oracle Clinical
DATA
DISCREPANCIES
Clinician
Monitor
Oracle Remote Data Capture
Investigator
DATA COLLECTION
APPROVE
REVIEW/VERIFY Oracle ClinicalOracle 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
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
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Licensing
» OC/RDC/TMS Business Processes Outsourcing � Benefits of perennial software licensing with the
convenience of a service
� Ease of entry & lower up-front investment
� Grows and adapts as clients add more studies
� No infrastructure
� Automatic upgrades
» JReview Admin and Read-only User � Short-term license structure
� Flexible
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Training
» Delivered instructor-led RDC OnSite live over the Internet � PI-specific training
� SITE-specific training
» Task-based user training for all associated internal roles in CDM, ClinOps, Validation and QA
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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
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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
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Lessons Learned
» Integrated solution provides real benefit to small organizations
» Single vendor provides: � One point of contact
� Enhanced cooperation
� Deep understanding of client’s processes, strengths, weaknesses
� Advantageous economics
» Growth potential for client and vendor
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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: � Hosting and subscription-based licensing
� Logistics
� Data management
� Training
� Support
» The combination of organizations and expertise minimizes risk and optimizes results
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Biography Kevin F. Shea Senior Clinical Solutions Director +1 610-772-5726 [email protected]
» 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.
»
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