eClinical Forum 2011 Spring Meeting        Cloud Computing:        What It Is and        How It Can Benefit        Clinica...
Goals and Agenda of Today       NIST Definition of Cloud Computing & Cloud Software       Clarify the Distinction Between ...
Disclaimer    About Me:     – VP of Commercialisation and Operations for Cmed Technology     – Formerly of Amgen (working ...
NIST Definition of Cloud Computing          "Cloud Computing is a model for enabling convenient,              on-demand ne...
Clarifying the Buzzwords: How Cloud fits               with ASP, SaaS and other models                         On-Premise ...
Five Essential Characteristics                     to Meet the Definition of a Cloud1. On-demand Self-Service: Do it yours...
Translating the Cloud Characteristics Into                     Real-World Benefits for Clinical Research                  ...
Use of Cloud Software in Clinical ResearchTwo common considerations and concerns:1. Can it be regulatory-compliant?       ...
There Are Four Different Types of                      Cloud Deployment Models                                            ...
Can a Cloud Be Regulatory Compliant?    A Cloud Software is a System, comprised of                                        ...
Are Clouds Secure?     How clinical data are managed today: touched by sites,     CROs and Sponsors across many channels: ...
Questions & Answers    Thank you!    For additional information on clouds computing,    especially in the regulatory space...
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Cloud computing: What is it and how it can benefit clinical research

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

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Cloud computing: What is it and how it can benefit clinical research

  1. 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. 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&ACambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 2
  3. 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 CmedCambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 3
  4. 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 :Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 4
  5. 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 standardizationCambridge, MA 11-13 April 2011 Copyright eClinical Forum 2011 5
  6. 6. Five Essential Characteristics to Meet the Definition of a Cloud1. On-demand Self-Service: Do it yourself, without vendor Service:2. Broad Network Access: Do it from anywhere3. Resource Pooling: Immediate economies of scale :4. Rapid Elasticity: Scale on- -demand, without penalty5. 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 :Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 6
  7. 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 ,Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 7
  8. 8. Use of Cloud Software in Clinical ResearchTwo 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…Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 8
  9. 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 areSources: Definition of Cloud Computing, Version 15, National Institute of Standards & Technology, October 7, 2009 , using hybrid modelsGartner Identifies the Top 10 Strategic Technologies for 2011, Gartner Group, October 19, 2010 ,Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 9
  10. 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, 2010Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 10
  11. 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, 2011Cambridge, MA 11-13 April 2011 Copyright eClinical Forum 2009 11
  12. 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_statenCambridge, MA, April 11-12 2011 Copyright eClinical Forum 2009 12

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