Primer on cloud computing and how it can be applied to clinical research.

1. eClinical Forum 2011 Spring Meeting
Cloud Computing:
What It Is and
How It Can Benefit
Clinical Research
Presented by Jim Haughwout
April 13, 2011

2. 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
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3. 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
premise
About Cmed Technology
– Provider of SaaS and on-premise eClinical solutions
premise
using private and community-based cloud models
based
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
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4. NIST Definition of Cloud Computing
"Cloud Computing is a model for enabling convenient,
on-demand network access to a shared pool of
demand
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"
There are three Cloud Computing Service Models:
Software, Platforms and Infrastructure Today focusing on
Infrastructure.
Cloud 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 http://csrc.nist.gov/groups/SNS/cloud-computing/cloud-def-v15.doc
:
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5. Clarifying the Buzzwords: How Cloud fits
with ASP, SaaS and other models
On-Premise Third-Party Hosted
Customized Off-the-Shelf
(Source Code Changed) (As-Is and Configured)
ASP SaaS
(Application Service Provision) (Software-as-a-Service)
Cloud Software Model Other SaaS Models
Delivered via Cloud Software-as-a-Service. All benefits of SaaS standardization
SaaS is a NIST Service Model for Cloud Software Range of architecture and provision models
All benefits from SaaS standardization and… May meet some NIST Essential Cloud
From ALL 5 NIST Essential Cloud Characteristics Characteristics
Cloud Software is a sub-set of SaaS (Not all SaaS is Cloud Software)
SaaS differentiated from ASP by assurance of off
off-the-shelf standardization
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6. Five Essential Characteristics
to Meet the Definition of a Cloud
1. On-demand Self-Service: Do it yourself, without vendor
Service:
2. Broad Network Access: Do it from anywhere
3. Resource Pooling: Immediate economies of scale
:
4. Rapid Elasticity: Scale on-
-demand, without penalty
5. Measured Service: Pay for what you use
: use—and no more
Analogy: How we use of Electricity (vs. traditional business software)
Source: Definition of Cloud Computing, Version 15, NIST, October 7, 2009. Download at http://csrc.nist.gov/groups/SNS/cloud-computing/cloud-def-v15.doc
:
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7. Translating the Cloud Characteristics Into
Real-World Benefits for Clinical Research
World
On-demand Clinical teams (on their own) can: set up trials, go-live, add sites or users,
Self-Service perform mid-trial updates, process 3rd
trial 3rd-party data or extracts, etc.
Enables not just elimination of projects and fees, also associated delays
Broad Enable all clinical trial users to access required clinical data and eClinical
Network functionality from wherever needed, without requiring local IT install or setup
Access Reduction of on-site (clinics thru main office) IT resource requirements
site
Resource Same performance & reliability regardless of location, trial size, or portfolio size
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 Automatically support increase (or decrease) in portfolio volume or study size…
Elasticity 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 Inherent alignment of costs and fees with portfolio and/and trial progression,
Service 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 http://csrc.nist.gov/groups/SNS/cloud-computing/cloud-def-v15.doc
,
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8. Use of Cloud Software in Clinical Research
Two common considerations and concerns:
1. Can it be regulatory-compliant?
compliant?
2. Is it secure?
Understandable, given some of news on widely
widely-used clouds, however…
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9. There Are Four Different Types of
Cloud Deployment Models
Most applicable for
Private: clinical research use
as of today
– Cloud for one organization Many large
companies
– Think “In-house systems” and “dedicated ASP”
house exploring use of on-
premise private
Community: clouds
– Cloud for organizations with similar mission and need Gartner Group
named Private
– Think “Pharma Network” and “Biotech Clusters” Clouds a strategic
technology for 2011
Public:
– Cloud for general use by anyone
– What most people think of when the hear, “Cloud Computing”
Hybrid: New enterprise
content solutions
– Composite of multiple cloud solutions that mix access to
– Integrated implementations of multiple cloud solutions applications and
regulatory and
safety updates are
Sources: Definition of Cloud Computing, Version 15, National Institute of Standards & Technology, October 7, 2009
, using hybrid models
Gartner Identifies the Top 10 Strategic Technologies for 2011, Gartner Group, October 19, 2010
,
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10. Can a Cloud Be Regulatory Compliant?
A Cloud Software is a System, comprised of
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 manage it for customers have been
validated for clinical operations for years
– Shared infrastructure and 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*
Source: FDA has App Stores Under Surveillance, GigaOM, August 31, 2010
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11. 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 or
party
on-premise in-house providers)
house
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
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
on-premise systems*
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
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12. Questions & Answers
Thank you!
For additional information on clouds computing,
especially in the regulatory space:
– NIST: http://csrc.nist.gov/groups/SNS/cloud
http://csrc.nist.gov/groups/SNS/cloud-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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