How Commercial Software Companies Can Encourage Open Source Development

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1 How Commercial Software Companies Can Encourage Open Source Development Evan Hahn Randomization and Trial Supply Solutions Lead, North America Mid-Market 2013 Medidata Solutions, Inc. 1

2 Acknowledgements Andrew Smith JD Dhaliwal Dennis Sweitzer My colleagues at Cytel 2013 Medidata Solutions, Inc. 2

3 Presentation Outline Propriety and Open Source Software (OSS) Proprietary Sandwich Examples of OSS contributions via proprietary development Current and potential applications in clinical development 2013 Medidata Solutions, Inc. 3

4 About Medidata Solutions We are a global technology company that provides a SaaS platform for clinical trials. Core components of the platform include EDC (Rave), IWR/ IRT (Balance), CTMS, Analytics (Insights), Trial Planning Solutions, and Protocol Design Estimate that close to 50% of all the data on pharma clinical studies move through our platform 2013 Medidata Solutions, Inc. 4

5 Proprietary Sandwich Open Source Apps API s Standards Proprietary Platform EDC (Rave) IWR (Balance) Analytics (Insights) Open Source Stack Linux Ruby on Rails 2013 Medidata Solutions, Inc. 5

6 1. Release OSS to the Community Medidata views it as our corporate debt to give back open source software Contribute open source code back to community Program conceived by software engineers and legal in late 2012 Formal program rolled out in Q Policy and Process to provide path 2013 Medidata Solutions, Inc. 6

7 2. Open Platform VIA API s and Standards Application Programming Interface (API s) Vehicle by which other software or code can connect to the platform Common among many commercial software solutions Standards encourage collaborative development Makes it easier to for disparate developers to build apps that work collectively (ex CDISC) 2013 Medidata Solutions, Inc. 7

8 MDSO Example: Developer Central An online community to support sponsors in their efforts to integrate various clinical trial solutions with the Medidata platform Intended to foster innovation and is a free service available to sponsors and others in clinical development Unfortunately, used mostly for point to point integration not up to it s full potential 2013 Medidata Solutions, Inc. 8

9 Developer Challenge Open the platform to the broader developer community Encourage open source development Want to tap into the living dynamic to see if we can learn from it and our customers can benefit from it Potential to extend platform to the benefit of our customers (clinical research Apps) Apps could be from commercial or academic/non-profit organizations, and be available at no cost (preferably no cost) First challenge: Patient engagement 2013 Medidata Solutions, Inc. 9

10 Response Adaptive Trial Proprietary Platform Revised Randomization Ratio Response Data Open Source Model 2013 Medidata Solutions, Inc. 10

11 On-study event/enrollment modeling Early in study - Identify problems & Refine Planning Are the protocol assumptions accurate? When to stop enrollment? Expected # patients (enrolled, randomized, etc)? Mid study - Evaluate Fixes & Monitor emerging issues When to stop randomizing patients? Are the revised assumptions accurate? Were changes effective? Do we need to re-evaluate our drug supply plans? Late in study - Plan for Closeout & Database lock When will the last Relapse occur? How many patients will be active in various phases? 2013 Medidata Solutions, Inc. 11

12 Predictive Trial Analytics Dashboard Events Enrollment Supply Platform Data 2013 Medidata Solutions, Inc. 12

13 Program Analytics Dashboard Trial 1 Trial 2 Trial 3 Platform Data 2013 Medidata Solutions, Inc. 13

14 Summary Even companies that develop software with a proprietary model can contribute free and open source software Commercial software companies and the user community can benefit by opening their solutions via API s Companies should facilitate and enable 3 rd party developers There is significant untapped potential to improve clinical development by extending the capabilities of existing commercial platforms 2013 Medidata Solutions, Inc. 14

15 Balance Professional Services Implementation Statement: Balance is a configurable RTSM solution that makes it possible for studies to be setup by Medidata, partners, or sponsors themselves with minimal training. Study by Study Medidata or Partner Build Enterprise Adoption - Knowledge Transfer Enablement workshops Mentoring 24/7 help desk Many enabled partners (and growing) 2013 Medidata Solutions, Inc. 15

16 Thank You Medidata Solutions, Inc. 16

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