Case Study - Developing a Clinical Application using Agile Methodology

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1 Case Study - Developing a Clinical Application using Agile Methodology Tony Hewer, Senior Quality & Regulatory Affairs Director Medidata Solutions Inc 1

2 Agenda Background Who we are and what we do Why we adopted Agile Today Future Q&A Succeeding with Agile Software Development Using Scrum Mike Cohn Addison-Wesley, 2010 The Scrum Alliance

Development Using Scrum Mike Cohn Addison-Wesley, 2010 The

3 Who we are and what we do Medidata's SaaS and professional service offerings enhance the efficiency of our customers' clinical trials with innovative solutions for study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. SaaS platform Medidata Clinical Cloud - Designer Grants Manager CRO Contractor CTMS Balance Patient Cloud Targeted SDV Rave Insights SQM Rave Safety Gateway Coder imedidata 3

randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics.

4 Patient Cloud BYOD Device! It is NOT a medical device. Today ios; tomorrow, Android and Windows 8 Closely coupled with Rave epro Easy to set up and administer [by the sponsor or CRO] in Rave and imedidata Medical device integrations with this product and/or with the MCC via Web Services 4

epro Easy to set up and administer [by the sponsor or CRO] in Rave and

5 Who we are and what we do HQ d in New York City, USA ~1000 employees USA, UK, Japan, China >500 clients and partners >14,000 clinical studies ~ 60TB of [source] data Customers - Sponsors - Pharma, biotech, medical devices, NFP orgs, academic, CRO partners In-house software development In-house and externalized hosting In-house and externalized customer and end-user support In-house, customer and externalized study setup Focused on delivering value to our customers via our SaaS-based solutions and our Professional Services 5

In-house software development In-house and externalized hosting In-house and externalized customer and end-user support In-house,

6 Why we adopted Agile Speed [to market] of new SaaS products of SaaS [existing] product releases of hot-fixes Nimbleness to market and customer needs Higher quality software Increased productivity in software engineering in software testing Reduce overheads and choke-points Note! We speak about our products being validated! But We were concerned about the regulatory expectations! But 6

productivity in software engineering in software testing Reduce overheads and choke-points Note!

7 Our approach Supported by executive leadership Scrum Master training Scrum Small teams 2-week sprints Recognition of ongoing technical debt User stories Feature Files - scenarios Massively increased automation Less emphasis on documentation Managing our customers expectations New products start with Agile / Existing products evolve to Agile Continuous organizational change 7

increased automation Less emphasis on documentation Managing our customers expectations New

8 New features Modified features Defect fixes Technical debt 8

9 Today 100% Agile X-border teams We have retired our old processes Fibonacci General acceptance and buy-in by our customers RFPs Audits High levels of automation 4 releases per year - Fixed-time sprints; fixed-time releases -> flexible features SIMT pushes to production Pre-releases [Internal] validation portal Audits Less traditional documents It s dynamic and fun! Reveals! Recruitment TDD/BDD Effective retrospectives Batman Using Jira (from Atlassian) Lego Consistent standards 9

flexible features SIMT pushes to production Pre-releases [Internal] validation portal Audits Less traditional documents

10 Where next? Expand Agile approach/scope Support setup DevOps enhancement Continuous validation Expanded and extended - scenario coverage [External] Customer portal to our validation evidence Refactor our customers approaches to auditing us Drive down technical debt (by refactoring) Treat our processes like our software Train and learn more! 10

Expanded and extended - scenario coverage [External] Customer portal to our validation

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12 In conclusion We would not be where we are today without having adopted Agile! We continue our journey of reinvention - the way we build, test and deploy our software We will continue to partner with our customers and regulators about what we re doing and how we re doing it Thanks! 12

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15 Case Study - Developing a Clinical Application using Agile Methodology Tony Hewer, Senior Director, Quality & Regulatory Affairs 03 April Medidata Solutions, Inc.

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