cloud computing: what is it and how it can benefit clinical research

Cloud Computing:What It Is andHow It Can Benefit Clinical Research

eClinical Forum 2011 Spring Meeting

Presented by Jim HaughwoutApril 13, 2011

Cloud Computing:What It Is andHow It Can Benefit Clinical Research

eClinical Forum 2011 Spring Meeting

Presented by Jim HaughwoutApril 13, 2011

Goals and Agenda of Today

� NIST Definition of Cloud Computing & Cloud Software

� Clarify the Distinction Between ASP, SaaS & Cloud

� Translate NIST’s Cloud Definition to the Clinical World

� Address Key Concerns Regarding

Use of Cloud Software in Clinical Research

� Q&A

Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009

Goals and Agenda of Today

NIST Definition of Cloud Computing & Cloud Software

Clarify the Distinction Between ASP, SaaS & Cloud

Translate NIST’s Cloud Definition to the Clinical World

Address Key Concerns Regarding


Copyright eClinical Forum 2009 2

Disclaimer

� About Me:– VP of Commercialisation and Operations for Cmed Technology

– Formerly of Amgen (working in IS, Clinical Development and Regulatory Operations functions)

– Architected, built, provided and bought ASP, SaaS, and cloud solutions for broad range of industries, but…

– Also implemented on-premise systems when these were insufficient– Also implemented on-premise systems when these were insufficient

� About Cmed Technology– Provider of SaaS and on-premise eClinical solutions

using private and community-based cloud models

� Role today– Sharing information on applicability cloud computing for clinical

development, based on NIST definitions and general industry models

� None of cited sources have paid relationships with me or Cmed

Copyright eClinical Forum 2009Cambridge, MA 11-13 April 2011

VP of Commercialisation and Operations for Cmed Technology

Formerly of Amgen (working in IS, Clinical Development and Regulatory

Architected, built, provided and bought ASP, SaaS, and cloud solutions for

premise systems when these were insufficientpremise systems when these were insufficient

premise eClinical solutions based cloud models

Sharing information on applicability cloud computing for clinical development, based on NIST definitions and general industry models

None of cited sources have paid relationships with me or Cmed


NIST Definition of Cloud Computing

"Cloud Computing is a modelon-demand network access to a shared pool of

configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be

rapidly provisioned and released with minimal management effort or service provider interaction"

Copyright eClinical Forum 2009

management effort or service provider interaction"

There are three Cloud Computing Service Models: Software, Platforms and InfrastructureCloud Software (to concentrate at the application level)

How does this differ from other hosting models?

Source: Definition of Cloud Computing, Version 15, NIST, October 7, 2009. Download at

Cambridge, MA 11-13 April 2011

NIST Definition of Cloud Computing

model for enabling convenient, demand network access to a shared pool of

configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be

rapidly provisioned and released with minimal management effort or service provider interaction"


management effort or service provider interaction"

There are three Cloud Computing Service Models: Infrastructure. Today focusing on

(to concentrate at the application level)

How does this differ from other hosting models?

: Definition of Cloud Computing, Version 15, NIST, October 7, 2009. Download at http://csrc.nist.gov/groups/SNS/cloud-computing/cloud-def-v15.doc

Clarifying the Buzzwords: How Cloud fits with ASP, SaaS and other models

On-Premise

ASP(Application Service Provision)

Customized(Source Code Changed)


Cloud Software Model

� Delivered via Cloud Software-as-a-Service.SaaS is a NIST Service Model for Cloud Software

� All benefits from SaaS standardization and…

� From ALL 5 NIST Essential Cloud Characteristics

Cloud Software is a sub-set of SaaSSaaS differentiated from ASP by assurance of off


Clarifying the Buzzwords: How Cloud fits with ASP, SaaS and other models

Third-Party Hosted

SaaS(Software-as-a-Service)

Off-the-Shelf(As-Is and Configured)

5Copyright eClinical Forum 2011

Other SaaS Models

� All benefits of SaaS standardization

� Range of architecture and provision models

� May meet some NIST Essential Cloud Characteristics

SaaS (Not all SaaS is Cloud Software)differentiated from ASP by assurance of off-the-shelf standardization

Five Essential Characteristics to Meet the Definition of a Cloud

1. On-demand Self-Service:

2. Broad Network Access: Do it from anywhere

3. Resource Pooling: Immediate economies of scale

4. Rapid Elasticity: Scale on-

5. Measured Service: Pay for what you use


Analogy: How we use of Electricity (vs. traditional business software)

Source: Definition of Cloud Computing, Version 15, NIST, October 7, 2009. Download at


Five Essential Characteristics to Meet the Definition of a Cloud

Service: Do it yourself, without vendor

Do it from anywhere

: Immediate economies of scale

-demand, without penalty

: Pay for what you use—and no more


Analogy: How we use of Electricity (vs. traditional business software)

: Definition of Cloud Computing, Version 15, NIST, October 7, 2009. Download at http://csrc.nist.gov/groups/SNS/cloud-computing/cloud-def-v15.doc

Translating the Cloud Characteristics Into Real-World Benefits for Clinical Research

On-demandSelf-Service

� Clinical teams (on their own) can:

perform mid-trial updates, process 3rd

� Enables not just elimination of projects and fees, also associated delays

BroadNetwork Access

� Enable all clinical trial users to access required clinical data and

functionality from wherever needed, without requiring local IT install or setup

� Reduction of on-site (clinics thru main office) IT resource requirements

Resource Pooling

� Same performance & reliability regardless of location, trial size, or portfolio size

� Architecture without any single points of failure, choke points, etc., …


Pooling � Architecture without any single points of failure, choke points, etc., …

� Enabling maintenance without interrupting clinical trial operations

� Inheriting investments in security, business continuity, and disaster recovery

Rapid Elasticity

� Automatically support increase (or decrease) in portfolio volume or study size…

� Enable changes in user base to support of key milestones (e.g., DBL)…

� Without need for capacity change projects and without change in performance

Measured Service

� Inherent alignment of costs and fees with portfolio and/and trial progression,

e.g., lower when trials or trial enrollment is delayed

� Transparent reporting of fees, abstracted in terms aligned with clinical operation

(e.g., CRFs, subjects and users vs. servers, data and sockets)

Cross-reference with Definition of Cloud Computing, Version 15, NIST, October 7, 2009, at


Translating the Cloud Characteristics Into World Benefits for Clinical Research

their own) can: set up trials, go-live, add sites or users,

trial updates, process 3rd-party data or extracts, etc.

Enables not just elimination of projects and fees, also associated delays

trial users to access required clinical data and eClinical

functionality from wherever needed, without requiring local IT install or setup

site (clinics thru main office) IT resource requirements

performance & reliability regardless of location, trial size, or portfolio size

Architecture without any single points of failure, choke points, etc., …


Architecture without any single points of failure, choke points, etc., …

Enabling maintenance without interrupting clinical trial operations

Inheriting investments in security, business continuity, and disaster recovery

Automatically support increase (or decrease) in portfolio volume or study size…

Enable changes in user base to support of key milestones (e.g., DBL)…

Without need for capacity change projects and without change in performance

costs and fees with portfolio and/and trial progression,

e.g., lower when trials or trial enrollment is delayed

Transparent reporting of fees, abstracted in terms aligned with clinical operation

(e.g., CRFs, subjects and users vs. servers, data and sockets)

, Version 15, NIST, October 7, 2009, at http://csrc.nist.gov/groups/SNS/cloud-computing/cloud-def-v15.doc


Two common considerations and concerns:

1. Can it be regulatory-compliant?

2. Is it secure?


Understandable, given some of news on widely



Two common considerations and concerns:

compliant?


Understandable, given some of news on widely-used clouds, however…

There Are Four Different Types ofCloud Deployment Models

� Private: – Cloud for one organization

– Think “In-house systems” and “dedicated ASP”

� Community: – Cloud for organizations with similar mission and need

– Think “Pharma Network” and “Biotech Clusters”– Think “Pharma Network” and “Biotech Clusters”

� Public:– Cloud for general use by anyone

– What most people think of when the hear, “Cloud Computing”

� Hybrid:– Composite of multiple cloud solutions

– Integrated implementations of multiple cloud solutions


Sources: Definition of Cloud Computing, Version 15, National Institute of Standards & Technology, October 7, 2009

Gartner Identifies the Top 10 Strategic Technologies for 2011, Gartner Group, October 19, 2010


There Are Four Different Types ofCloud Deployment Models

house systems” and “dedicated ASP”

Cloud for organizations with similar mission and need

Think “Pharma Network” and “Biotech Clusters”

� Most applicable for clinical research use as of today

� Many large companies exploring use of on-premise private clouds

� Gartner Group named Private Clouds a strategic Think “Pharma Network” and “Biotech Clusters”

What most people think of when the hear, “Cloud Computing”

Composite of multiple cloud solutions

Integrated implementations of multiple cloud solutions


, Version 15, National Institute of Standards & Technology, October 7, 2009

, Gartner Group, October 19, 2010

Clouds a strategic technology for 2011

� New enterprise content solutions that mix access to applications and regulatory and safety updates are using hybrid models

Can a Cloud Be Regulatory Compliant?

� A Cloud Software is a System, comprised of– SaaS software

– Underlying shared infrastructure

– Processes to manage it

� Compliance of Systems can be assured through CSV

� Nothing is new in application of CSV to Cloud Software– SaaS software and processes to

validated for clinical operations for years

– Shared infrastructure and processesbeen validated for clinical operations for years


Many validated private and community clouds exist. Regulators are exploring validation of public clouds*

Source: FDA has App Stores Under Surveillance, GigaOM, August 31, 2010


Can a Cloud Be Regulatory Compliant?

A Cloud Software is a System, comprised of—

shared infrastructure

Compliance of Systems can be assured through CSV

Nothing is new in application of CSV to Cloud Softwareto manage it for customers have been

validated for clinical operations for years

processes manage it for customers have been validated for clinical operations for years


Many validated private and community clouds exist. Regulators are exploring validation of public clouds*

Are Clouds Secure?

� How clinical data are managed today: touched by sites, CROs and Sponsors across many channels:– Paper (shipped via public carriers)

– Electronic (via third-party ASP and SaaS providers oron-premise in-house providers)

� Private or Community Cloud use does not change this� Private or Community Cloud use does not change this– Community Cloud providers are same as SaaS providers

– Private Cloud providers are same as ASP & on

� Like today, both leverage economies of scale for greater investment in security infrastructure, often providing a higher level of security than on


Sources: Cloud Computing is More Secure Than You Think, InfoWorld, May 4, 2010,

Interview with Harold Moss, IBM, Chief Technology Officer of cloud computing strategy, February 27, 2011


Are Clouds Secure?

How clinical data are managed today: touched by sites, CROs and Sponsors across many channels:

Paper (shipped via public carriers)

party ASP and SaaS providers orhouse providers)

Private or Community Cloud use does not change thisPrivate or Community Cloud use does not change thisCommunity Cloud providers are same as SaaS providers

Private Cloud providers are same as ASP & on-premise providers

Like today, both leverage economies of scale for greater investment in security infrastructure, often providing a higher level of security than on-premise systems*


, InfoWorld, May 4, 2010,

Harold Moss, IBM, Chief Technology Officer of cloud computing strategy, February 27, 2011

Questions & Answers

� Thank you!

� For additional information on clouds computing, especially in the regulatory space:

– NIST: http://csrc.nist.gov/groups/SNS/cloud

– Industry Analyst in cloud and utility computing:– Industry Analyst in cloud and utility computing:James Staten, Vice President and Principal Analyst at Forrester Research

http://www.forrester.com/rb/analyst/james_staten

http://blogs.forrester.com/james_staten

Cambridge, MA, April 11-12 2011 Copyright eClinical Forum 2009

Questions & Answers

For additional information on clouds computing, especially in the regulatory space:

http://csrc.nist.gov/groups/SNS/cloud-computing/

Industry Analyst in cloud and utility computing:Industry Analyst in cloud and utility computing:James Staten, Vice President and Principal Analyst at Forrester Research

http://www.forrester.com/rb/analyst/james_staten and

http://blogs.forrester.com/james_staten


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