Case Study - Developing a
Clinical Application using Agile
Methodology
Tony Hewer, Senior
Quality & Regulatory Affairs Director
Medidata Solutions Inc
3rd April 2014, GSK, Stevenage
1
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 - http://www.scrumalliance.org
https://www.atlassian.com/jirajr
3rd April 2014, GSK, Stevenage
2
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
3rd April 2014, GSK, Stevenage
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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
3rd April 2014, GSK, Stevenage
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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
3rd April 2014, GSK, Stevenage
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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…
3rd April 2014, GSK, Stevenage
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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
3rd April 2014, GSK, Stevenage
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New features
Modified features
Defect fixes
Technical debt
3rd April 2014, GSK, Stevenage
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Today

100% Agile

X-border teams

We have retired our old processes

Less “traditional” documents

Fibonacci

It’s dynamic and fun! Reveals!

General acceptance and buy-in by
our customers
 RFPs
 Audits

Recruitment

TDD/BDD

Effective retrospectives

High levels of automation

Batman

4 releases per year - Fixed-time
sprints; fixed-time releases ->
flexible features

Using Jira (from Atlassian)

Lego

Consistent “standards”


[Internal] validation portal

SIMT pushes to production
 Pre-releases
Audits
3rd April 2014, GSK, Stevenage
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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!
3rd April 2014, GSK, Stevenage
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3rd April 2014, GSK, Stevenage
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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!
3rd April 2014, GSK, Stevenage
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3rd April 2014, GSK, Stevenage
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3rd April 2014, GSK, Stevenage
Case Study - Developing a Clinical
Application using Agile Methodology
Tony Hewer, Senior Director,
Quality & Regulatory Affairs
03 April 2014
© 2014 Medidata Solutions, Inc.