cloud computing: what is it and how it can benefit clinical research
DESCRIPTION
Primer on cloud computing and how it can be applied to clinical research.TRANSCRIPT
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
Use of Cloud Software in Clinical Research
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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
Copyright eClinical Forum 2009 3
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"
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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"
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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)
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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
Cambridge, MA 11-13 April 2011
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)
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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
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Analogy: How we use of Electricity (vs. traditional business software)
Source: Definition of Cloud Computing, Version 15, NIST, October 7, 2009. Download at
Cambridge, MA 11-13 April 2011
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
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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., …
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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
Cambridge, MA 11-13 April 2011
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., …
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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
Use of Cloud Software in Clinical Research
Two common considerations and concerns:
1. Can it be regulatory-compliant?
2. Is it secure?
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Understandable, given some of news on widely
Cambridge, MA 11-13 April 2011
Use of Cloud Software in Clinical Research
Two common considerations and concerns:
compliant?
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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
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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
Cambridge, MA 11-13 April 2011
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
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, 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
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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
Cambridge, MA 11-13 April 2011
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
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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
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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
Cambridge, MA 11-13 April 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*
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, 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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