3 Ways to Implement a Clinical Trial Management System
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The document outlines three methodologies for implementing a Clinical Trial Management System (CTMS): Big Bang, Rolling Release, and Modular. Each methodology has its pros and cons, with case studies highlighting their implementation processes, user adoption, and the impact on return on investment (ROI). Perficient, an IT consulting firm, offers expertise and solutions in this domain, helping clients enhance their clinical trial processes.
3 Ways to Implement a Clinical Trial Management System
- 1. 3 WAYS TO IMPLEMENT A CLINICAL TRIAL MANAGEMENT SYSTEM
- 2. 2 ABOUT PERFICIENT Perficient is a leading information technology consulting firm serving clients throughout North America. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities.
- 3. 3 Founded in 1997 Public, NASDAQ: PRFT 2014 revenue $456.7 million Major market locations: Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis, New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto Global delivery centers in China and India >2,600 colleagues Dedicated solution practices ~90% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards PERFICIENT PROFILE
- 4. 4 Business Process Management Customer Relationship Management Enterprise Performance Management Enterprise Information Solutions Enterprise Resource Planning Experience Design Portal / Collaboration Content Management Information Management Mobile BUSINESSSOLUTIONS 50+PARTNERS Safety / PV Clinical Data Management Electronic Data Capture Medical Coding Clinical Data Warehousing Clinical Data Analytics Clinical Trial Management Healthcare Data Warehousing Healthcare Analytics CLINICAL/HEALTHCAREIT Consulting Implementation Integration Migration Upgrade Managed Services Private Cloud Hosting Validation Study Setup Project Management Application Development Software Licensing Application Support Staff Augmentation Training SERVICES OUR SOLUTIONS PORTFOLIO
- 5. 5 AGENDA Topic Welcome and Introduction CTMS Implementation Methodologies Methodology Pros and Cons Case Study Q&A
- 6. 6 WELCOME & INTRODUCTION Param Singh Director of Clinical Trial Management Solutions Life Sciences, Perficient CTMS practice lead since 2008 – Leads the team that implements, supports, enhances, and integrates Siebel Clinical Extensive Siebel Clinical implementation experience – 15+ years of experience implementing Siebel Clinical – 30+ implementations and integrations – Spearheaded the creation of ASCEND, an official Oracle Accelerate solution for Siebel Clinical
- 7. 7 3 CTMS IMPLEMENTATION METHODOLOGIES Big Bang Rolling Release Modular
- 8. 8 BIG BANG • Project incorporates all requirements for the CTMS, including integration, automation, and system functionality • Phases include analysis, design, test/validation and deployment • All project requirements are identified during analysis and documents are signed off sequentially
- 9. 9 ROLLING RELEASE • Project divided into iterations • Each iteration includes analysis, design, test and potentially deployment. With rolling releases, the goal is to go live/release with each iteration • Ideally governed by one validation plan
- 10. 10 MODULAR • System implemented quickly using out-of-the-box functionality • Enable modules slowly over time to larger user group, as adoption rate and core business allows
- 11. 11 BIG BANG PROS AND CONS • The time span between analysis and deployment can be high if there are many requirements, including configuration, integration and reports. This leads to changing requirements and delayed timelines. • The stakeholders/users have little to no visibility into the application design until it is completely designed and implemented. Rework is often required since expectations may have been different. • Project failure rate is higher with this methodology. • Business can’t reap the benefits of the system until deployment, therefore ROI is delayed. • Change management can be difficult when releasing a new system and revised processes all at once, and to a larger user community.
- 12. 12 CASE STUDY – BIG BANG Business Need • New CTMS to be implemented • Enhancements needed to support core business requirements • Key integrations needed to eliminate dual data entry Implementation Approach • Big Bang – 12+ month project to implement all requirements with a large implementation team – Additional involvement/resource commitment needed from client business and IT organization Benefits Realized / Challenges • Went live with system after 12+ months – Users were trained at the end of the implementation on entire system – Core functionality, integrations, and enhancements started to be used immediately – Multiple workstreams in parallel, so more coordination needed along the way – Change management and communication workstreams were crucial to keep business engaged and excited about new system – CTM process was completely revamped with new system, in depth training was needed on system and process/SOPs – Larger transformation/change to manage – Less appetite for additional changes in subsequent releases
- 13. 13 ROLLING RELEASE PROS AND CONS • System is implemented during each iteration and demos to the business can take place after each iteration to further tweak the future design of the system, if needed. • Likelihood of changes being needed after release is slim because stakeholders are engaged throughout the process. • It is easier to adopt a new system and associated processes in smaller chunks. • ROI is achieved sooner because high priority requirements are implemented and released sooner.
- 14. 14 CASE STUDY- ROLLING RELEASE Business Need • New CTMS to be implemented • Enhanced Payments Module for unique business process • EDC integration with CTMS Implementation Approach • Rolling Release – 1st workstream: Base ASCEND Accelerator implementation – 2nd workstream: Payments Module release, along with additional enhancements – 3rd workstream: Trip Report Module release, along with EDC Integration Benefits Realized • Went live with base system in about 8 weeks – Users were trained and using the system very quickly – Core functionality started to be used immediately • Subsequent workstreams – Release of additional functionality was timed, with resources scheduled to ensure user adoption – Able to manage change according to the ability of the user community – Gives time for users to get familiar with system before introducing additional complexity and automation, etc.
- 15. 15 MODULAR PROS AND CONS • System is implemented very quickly, with the included functionality of all modules. • Can be done with OOTB system or with the use of a trusted, validated “accelerator” solution. • Focus on modules that relate to core business functions, and enable other modules as user community are ready for them. • ROI is achieved very quickly with an OOTB implementation. • Additional functionality can be released in real-time, since it is an administrative change to enable additional modules. • Can still move forward with enhancements using rolling release methodology.
- 16. 16 CASE STUDY- MODULAR RELEASE Business Need • New CTMS to be implemented • No integrations needed immediately • Smaller user community looking for immediate benefits of a centralized system Implementation Approach • Modular Release – Base ASCEND Accelerator implementation Benefits Realized • Went live with base system in about 8 weeks – Only enabled key modules in first phase via administration – Limited core functionality started to be used immediately • Subsequent workstreams – Able to manage change according to the ability of the user community via administration of system – No additional development, IT, consulting costs – Gives time for users to get familiar with system before introducing additional modules via administration of system – Training was focused on only modules that were enabled – System does not overwhelm users with complexity
- 17. 17 QUESTIONS?
- 18. 18 www.facebook.com/perficientwww.twitter.com/perficient_LS For more information, please contact: Param.Singh@perficient.com LifeSciencesInfo@perficient.com (Sales) +1 877 654 0033 (U.S. Sales) +1 303 570 8464 (U.S. Sales) +44 (0) 1865 910200 (U.K. Sales) THANK YOU linkedin.com/company/perficient