Before & AFTER THE HONEYMOON: The Criticality of Implementation to the Success of Innovation

1. Clinical Research Informatics World Waife & Associates, Inc. May 2015 Before & AFTER THE HONEYMOON:The Criticality of Implementation to the Success of Innovation

2. before

3. Innovation as Victim • Innovation (of whatever kind) in our industry faces a multiplicity of threats • Leadership (clear, visible, sustained) • Governance • User Buy-in • Understanding the Extent of Change • Budget (did you plan for 3X ?) • Skill (in-house or recruitment needed?) • Infrastructure • TIME

4. Intertwined “Before” and “After” are intertwined Without laying the foundation before researching and acquiring new tools, you could be caught in an un-implementable situation This applies to all of the components Understanding and anticipating this is part of the solution

5. The Key Questions Why is the innovative thing you just saw important to yourbusiness, now? How does it fit with your company’s key business goals? Can you be the champion, or do you need one? How will you come to understand the impact of this innovation on the function(s) it “disrupts”? Who will lead you through the “disruption” to the other side, where the innovation is applied and is working?

6. Where & Wherefore Informatics?

7. Where & Wherefore Informatics? • Not an obvious question • Is Informatics a fancy word for IT? • Is Informatics even in IT? Or in the Business? • Does Informatics exist on its own or is it a virtual role? • Why do we care? • Because the politics starts with this question • Politics definitely ruins the honeymoon • Without any “informatics” it may go more smoothly • …or it may be completely unworkable in your infrastructure, standards, network, security and privacy rules

8. Informatics or Not… Who does what? Who knows what? Who pays? Who decides?

9. Why We Care About Implementation • A large CRO seeking to implement a more basic and practical information flow and eTMF for Study Startup • Corporate security firewalls prevented remote access • A small Biopharma wanted to bring key apps in-house instead of at multiple CROs • Their only IT expertise in-house was servers and networks • A large pharma seeks integration of innovative niche tools into established sophisticated software environment • The project remains stalled between Business(es), IT, an existing Informatics function, Contracts and Finance

10. “But We Know All About Change Management…” • Rarely true • For most companies, change management is a throwaway • An online training module • Posters in the hallways • Lunch ‘n’ Learn

11. “But I Have a PMO…” • The Project Management Office • The place where you abdicate responsibility to Staffers instead of retaining ownership in the Line • Like today’s Contracts Managers, Project Managers have become obstacles instead of enablers • Inflexibile • “Standards” driven • Protecting their role/power/job

12. Solutions

13. Key Elements Plan for the impact of disruptive innovation Understand specifically your political and organizational obstacles Take the time to identify and modify the work processes affected Apply the best implementation skills you can find, inside or outside Budget through to the end! Maintain executive commitment through to the end Set reasonable expectations

14. Setting Expectations • How often have new technologies in clinical development over-promised and under-delivered? • Costly • Feeds cynicism • Feeds change fatigue • Setting the correct expectations is a balance between being seen as an obstacle or playing the “enabler” • The correct expectations • Are a “stretch” • But most importantly, are clearly articulated • …and, we hope, met

15. Expectations Loop

16. After…the vendors are gone, the executives are gone, it’s just you

17. To Reach the Speaker Ron Waife ronwaife@waife.com +1 781 449-7032 www.waife.com