Preparing for Your Oracle, Medidata, and Veeva CTMS Migration Project
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There are multiple reasons why companies migrate to a new clinical trial management system (CTMS). Still, the two most common are mergers and acquisitions (i.e., CTMS consolidation) and the desire to switch CTMS vendors. Regardless of the reason, many of the best practices, processes, and tools are the same. In this webinar, we looked at the migration approaches taken across several case studies. You’ll come away with an understanding of: Pros and cons of each CTMS migration method Types of migration tools, including APIs, ETL tools, and adapters Approximate timelines and costs associated with each migration method The topics discussed in this webinar can be applied to any CTMS migration project, whether you’re moving to or from Oracle’s Siebel CTMS, Medidata’s Rave CTMS, and Veeva’s Vault CTMS.
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Preparing for Your Oracle, Medidata, and Veeva CTMS Migration Project
- 1. WEBINAR Preparing for Your Oracle, Medidata, and Veeva CTMS Migration Project
- 2. 2 Tom Hogan Chief Operating Officer Who We Are AN INTRODUCTION TO We’re a global digital consultancy transforming how the world's leading enterprises and biggest brands connect with customers and grow their businesses. With Perficient, you get experience and expertise, speed and agility, and a healthy dose of pragmatism to drive your business forward.
- 3. 3 ~4500 Employees W E A R E Global in Our Delivery We have office locations across North America and fully owned global and domestic delivery centers around the world. Allentown, PA Ann Arbor, MI Atlanta, GA Boston, MA Bozeman, MT Cedar Rapids, IA Charlotte, NC Chicago, IL Columbus, OH Dallas, TX Denver, CO Detroit, MI Fairfax, VA Fargo, ND Houston, TX Irvine, CA Lafayette, LA Milwaukee, WI Minneapolis, MN New York, NY San Francisco, CA Seattle, WA St. Louis, MO Toronto, ON Washington, D.C. North America Latin America Mexico City, Mexico Medellin, Colombia Bogota, Colombia Cali, Colombia Chennai, India Nagpur, India Bangalore, India India Hangzhou, China China Oxford, UK Novi Sad, Serbia Europe
- 4. 4 AT-A-GLANCE Perficient Profile Alliance partnerships with major tech vendors Multiple vendor & industry tech and growth awards Global delivery centers in China, India and Mexico Dedicated solution practices 35 Global Locations $565M 2019 Revenue 1997 Founded in ~4,500 Colleagues ~90% Repeat Business Rate PRFT Public, NASDAQ
- 5. 5 Industry Expertise Our experience in the life sciences industry empowers us to help companies discover, develop, and manufacture products that help people feel better and live longer. We also help them enhance their customer experience and achieve operational excellence. I NDUSTRY Life Sciences 30+ of the world's leading public pharmaceutical, biotechnology, and medical device companies count on us . We helped a pharmaceutical giant transform the way it performs its medical coding activities, from capture to code. Project Spotlight DigitalTechnologyStrategy Clinical Safety
- 6. 6 Param Singh Director, Life Sciences [email protected] • 10+ years with Perficient • 20+ years of experience implementing CTMS
- 7. 7 45+ CTMS PROJECTS. ORACLE, MEDIDATA & VEEVA EXPERIENCE. WE PLAY NICE. WITH EVERYONE.
- 8. 8 Clinical Operation Solutions Practice Services Implementation Manage implementations of CTMS solutions, whether off-the-shelf applications from third- party vendors or custom-built digital solutions related to clinical operations. Integration Build interfaces between CTMS solutions and other clinical and non-clinical systems. Training Develop and/or deliver standard and custom training classes and materials. Process Guidance Provide insight, advice, and solutions to specific CTMS issues based on industry best practices. Advisory services to help clients optimize, streamline, and harmonize clinical operations business process.
- 9. 9 Today’s Agenda • Should We Migrate? • What Should We Migrate? • How Should We Migrate? • When Should We Migrate? • Q&A
- 10. 1010 Should We Migrate? (Purpose) What are the benefits of having historical study data in the new CTMS? • Comprehensive reporting • A complete picture of each study What are the benefits of having current study data in the new CTMS? • All study team members working in one system within one set of business processes • More cost-effective for IT to support and maintain one system
- 11. 11 Should We Migrate? (Purpose) What are the risks of migrating? • Loss of Functionality: New CTMS might not have the same functionality as all combined legacy systems and tools • Loss of Data: Data could be lost in the process of cleaning and/or migrating • Time Lag: Could be a gap between when the data is unavailable in the legacy system and when it is available in the new system • Time Overlap: One study could be available in two systems before the legacy system is decommissioned
- 12. 12 Example Scenarios • Recently secured a new, global client • Several large-scale and long-term studies planned or already started • Limited human resources to manage studies; need to operate as efficiently as possible • Limited IT department to support systems and tools Growing CRO • For all studies of all sizes, need to track subject data, even after officially closed • New Clinical Director requires comprehensive reporting on study, site, and vendor expenses • Recently implemented a data warehouse Oncology Pharma
- 13. 1313 What Should We Migrate? (Scope) Scoping takes place on two levels: 1. Study: Which studies should be migrated? 2. Data Type: Which types of data should be migrated for all of the studies chosen? Begin with a study-by-study analysis: • Compare each study timeline to your CTMS implementation timeline, especially CTMS go-live date and legacy system cutoff date(s) • For current studies, consider the volume of work that remains, given available resources
- 14. 14 Example Studies EndSoon Study LastLong Study StartSoon Study Study ends in three months (before legacy system cutoff) Study will continue for at least one year post-CTMS go-live Study begins one month before CTMS go-live Manageable volume of work with available staff Large volume of work Moderate volume of work, but do not need to use CTMS for first 2 months Migrate = No Migrate = Yes Migrate = No
- 15. 15 What Should We Migrate? (Scope) • Contacts • Subject Visits • Accounts • Adverse Events • Addresses • Protocol Deviations • Products • Correspondence Data Types: Which are available in the new CTMS? • Programs/Projects • Site Visit Reports • Studies • Investigator Payments • Sites • Vendor Expenses • Subjects • Documents
- 16. 16 What Should We Migrate? (Scope) • Contacts • Subject Visits • Accounts • Adverse Events • Addresses • Protocol Deviations • Products • Correspondence • Programs/Projects • Site Visit Reports • Studies • Investigator Payments • Sites • Vendor Expenses • Subjects • Documents Which are you currently tracking?
- 17. 17 What Should We Migrate? (Scope) Which of the remaining data types do you need in the system going forward? Think: • Extracting and/or reporting data • No need for correspondence; no reporting needs • No need for adverse events; safety system is the system of record • Acceptable workarounds • Keeping the existing vendor payments tool • Approved site visit reports can be printed and archived
- 18. 1818 How Should We Migrate? (Methods) Inventory your source systems: Where does the data currently live? • Spreadsheets • MS Access databases • Home-grown databases • Word documents • Document management dystem • Accounts payable system • Existing CTMS
- 19. 19 How Should We Migrate? (Methods) How many records do you have of each date type in each source system? • Use reports or embedded functions that provide row and column counts How closely does the source system format map to the CTMS format? Think: • Relationships: one-one, one-many, many-many • Attributes: fields • Data Standards: field contents
- 20. 2020 How Should We Migrate? (Methods) Manual migration vs. automated migration • Automated Options: • Embedded Tools • Existing External Tools • Custom-built Tools To choose a method, consider: • Available Tools • Available Staff • Volume • Complexity • Budget • Time
- 21. 21 Technical Approach: In-house to In-house CTMS
- 22. 22 Technical Approach: In-house to Standard Cloud CTMS
- 23. 23 Technical Approach: In-house to Custom Cloud CTMS
- 24. 24 When Should We Migrate? (Timing) Timing depends on your CTMS rollout strategy • Big Bang: All studies go live at the same time • Study-by-Study: Begin with a pilot study, roll out subsequent studies one by one Recommendation: Study-by-Study • Iron out kinks in business processes and training materials during pilot • Increases user adoption • Easier to manage training rollout
- 25. 2525 Summary 4 Phases of CTMS Data Migration Analysis • Purpose: What is the business driver behind the migration? • Scope: Which studies do we need? Which data types do we need for those studies? How will the data be used? • Methods: What tools and resources are available, and how do they fit with our budget and timeline? • Timing: What makes the most sense, considering our CTMS rollout plan?
- 26. 2626 Give Your CTMS Migration a Head Start This CTMS Migration jump start is designed to help begin your journey to a new platform. We will use our CTMS and data migration experience, along with our knowledge of the target CTMS, to assess your situation and goals and develop a comprehensive proposed migration solution. Upon completion of the jump start, you will be in a position to embark on the first work stream and phase of the migration quickly and effectively. Deliverables: • Implementation plan with timeline and milestones • List of responsibilities and future project deliverables • Pricing by work stream and phase • Migration process and data flow diagram 2 Weeks / No Cost
- 27. 2727 Launch Your CTMS Migration With a Clear Plan This CTMS migration jump start will help begin your journey to a new platform. We will use our CTMS and data migration experience, along with our knowledge of the target CTMS, to assess your situation and goals, capture your requirements, and develop a comprehensive action plan. Upon the completion of the jump start, you will be ready to begin the technical portion of the migration. Deliverables: • Implementation plan with timeline and milestones • List of responsibilities and future project deliverables • Pricing by work stream and phase • Migration process and data flow diagram • Identification of CTMS data entities for migration • Draft Migration Validation Plan and Protocol • Draft Migration Requirements Specification 4 Weeks / $50K+
- 28. 28 Param Singh Director, Life Sciences [email protected] • 10+ years with Perficient • 20+ years of experience implementing CTMS
- 29. Questions?
- 30. Thank You