Open Source Development and Innovation at OpenClinica Cal Collins OpenClinica, LLC @CalCollins1 1

Open Source Development and

Innovation at OpenClinica

Cal CollinsOpenClinica, LLC

@CalCollins1

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Ants!

Ants work together in an unselfish, altruistic fashion for the good of their colony.

This maximizes the colony’s ability to reproduce.

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Governing Dynamics

When everyone involved in an open source project does not only what’s best for themselves but what is good for the group, you gain exceptional leverage from open source.

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Outline About OpenClinica Why Open Source? How to do it?

Collaboration, Innovation, Passion Solve a problem/meet a need Keep barriers low Align Incentives

How OpenClinica does it Conclusion

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The OpenClinica Community Open source clinical trial software platform Over 1,400 installations, used in thousands of trials Global community of over 20,000

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What is OpenClinica? Featured capabilities:

Electronic data capture Clinical data management Highly configurable with

minimal technical knowledge Role-based access Audit trails, e-sigs Options to extend with

additional modules Powerful web-services API 100% web-based

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R&G Pharma Studies

K&L Consulting

Center for Translational Molecular Medicine

PRA International

Atlantic Research Group

European Society of Anesthesiology

University of Utah

Social & Scientific Systems, Inc (S-3)

Advanced Surgical Design and Manufacture

Kemri-Wellcome Research Program

Who uses OpenClinica?

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Retina Implant

National Institutes of Health

Partners HealthcareDrugs for Neglected Diseases Initiative

International Genomics Consortium

QPS

CHU Nimes

World Health Organization

SAFE-T Consortium

Cleveland Clinic

Baylor Research Institute

Medical Research Council

Ascension Orthopedics

BioDelivery Sciences International

Polaris Pharma

Johns Hopkins

University of SydneyFamily Health International

Imaging Endpoints

Oxford University

Butantan Institute

Edison Pharmaceuticals

Slate Pharmaceuticals

Molecular Neuroimaging

BIOP

Theradex

AIBILI

MDxHealth

bioRASI

Terumo

Sequana Medical

Nerviano Medical Sciences

CardioDx

Quartesian

The Kirby Institute for Infection and Immunity in Society

Michigan Institute for Clinical and Health Research

University of Leipzig

InspireMD

Joanneum Research

Cytel

CooperVision

WuXi

HemCon

BIOCAD

AbbottMassachusetts General Hospital

Industry sponsors

Contract Research Organizations (CROs)

Academic Centers

Government Agencies

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OpenClinica LLC

Vision: Improve health outcomes through open technology

Founded 2006

For-profit entity

29 employees

HQ: Waltham, MA USA

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OpenClinica Enterprise Edition

Subscription-based Software-as-a-Service delivery & support

Ongoing Upgrades Regulatory compliance Comprehensive

training Migration from

Community Edition

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OC Community = A rich ecosystem of options

Users

Developers

Service Providers

User Groups

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Why Open Source?When people can rapidly download and try things for free, share ideas with a community, and see each others’ source code, a few surprising things happen:

It’s easier to evaluate… all the way down to the code Technologies get ‘mashed up’ in highly innovative ways Best practices emerge and are shared quickly Interoperability is easier Business can focus on where they contribute the most

value, rather than on the ‘plumbing’

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What Makes Open Source Work?

Collaboration

Innovation

Passion

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Why Collaborate?

Incentives matter.

What are they?

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• Others help you improve or maintain your module/code/ documentation

• You learn from others

• You gain recognition

• You earn money

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Collaborate on what?

Ultimately, it’s all about delivering tools that help to answer research questions.

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© Taken from: Farr J, “Making Open Source Work”, Apache Software Foundation, Sep 2008.

© Taken from: Farr J, “Making Open Source Work”, Apache Software Foundation, Sep 2008.

© Taken from: Farr J, “Making Open Source Work”, Apache Software Foundation, Sep 2008.

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Innovation

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Innovation does not occur in a vacuum!

© Taken from: Farr J, “Making Open Source Work”, Apache Software Foundation, Sep 2008.

© Taken from: Farr J, “Making Open Source Work”, Apache Software Foundation, Sep 2008.

© Taken from: Farr J, “Making Open Source Work”, Apache Software Foundation, Sep 2008.

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Last but not least

Passion!

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“…there is one ingredient in our [open source] communities that really makes us tick. It’s not a single tool like GitHub or the

way we have conversations on IRC or mailing lists. It’s something that each and every one of us brings to the table every

day. The secret ingredient that really makes open source work is passion.”

- Jason Hibbets, Red Hat

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Collaboration + Passion = Culture

Heightened loyalty

Amplified word-of-mouth

Better feedback and contribution

Self-policing

Emotional connections

Passion = more fun!

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OpenClinica – OSS “Selling Points” Cost Efficient

It Allows Flexibility

It’s More Secure

Plenty of Support

A Product You’re Proud Of

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What We Did Well From the Start1. Established and communicated core values, then stick to

them (built trust, especially important as a for-profit)

2. Made IP practices clear (LGPL license, trademark policy, principles for OSS versus proprietary)

3. Encouraged open, transparent, unmoderated communication through “PRIM” (Portal, Repository, Issue Tracker, Mailing List)

4. Made it easy to get the code and the packaged software

5. Created simple, familiar extension points – (example: allowing html/js in CRFs)

6. Adopted and implemented recognized standards26

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Freedom and Transparency

Open, transparent software development empowers users

Backlog and roadmap – jira.openclinica.com

With OpenClinica’s open source model, it’s hard for bugs to hide

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Lessons Learned1. Respond quickly to contributions and keep barriers low

2. Put the code where the developers are

3. Timeboxed Releases

4. Work in small increments – Minimally Releaseable Features (MRFs) and User Stories

5. Release early and often

6. Test test test

7. Keep libraries and components up to date

8. Do #7, #8, and #9 all at the same time (hint: automation is your friend)

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Extensibility

SOAP API - a community contribution

RESTful APIs CRF widgets (slider,

barcodes, jQuery) Extract formats: Stata, R Translations Extensions: Big data /

images

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Cornerstones

Good data is the cornerstone for success Data Metadata Provenance

Standards-based APIs31

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Tools and Processes Github

Automated tests for everything In past six months, OpenClinica has more

commits of test code than of application code

Behavior Driven Development Features Acceptance Criteria Scenarios

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DevOps

Continuous delivery is fast becoming a necessity

This is where some of the best new Open Source work is being done - Vagrant, Docker, OpenStack

Tools alone are not enough (even great tools like Jira, Jenkins, Cloud, and Selenium!). In order to succeed people have to trust each other and want to work together.

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Current Priorities

Engage patients

Embrace mobile

Continue to lower barriers “Vagrant up” for setup Self-service SaaS

Modernize the code and UI while maintaining continuity

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Current Priorities

Increase the awareness of who is working on what:

Publicize extensions at OpenClinica.com/extensions

Discuss on OpenClinica.com/forums Use Github & JIRA Document knowledge on the wikibook

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Current Priorities

Build bridges with other OSS communities:

OpenSpecimen/caTissuetranSMART/i2b2Enketo/OpenDataKitR

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Current Priorities

Align incentives for users, service providers, and developers to share, coordinate, and benefit:

Allow paid extensions Support built-in metrics and feedback Enable modular, ‘snap-in’ functionality

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Thank You!

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Cal CollinsOpenClinica, LLC

ccollins@openclinica.com @CalCollins1