What is a "Cloud"? - Definition of Cloud Computing - Benefits of Cloud Computing - Clinical Regulations vs. the Cloud - The Cloud in Clinical Trials - Get Started with the Cloud

1. Clinovo
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HOW CAN BIOTECH COMPANIES GET
STARTED WITH CLOUD FOR CLINICAL TRIALS?
Presented by
Marc Desgrousilliers, CTO @ Clinovo

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
What is a ‘Cloud’?
Marketing Definition:

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Technical Definition:
What is a ‘Cloud’?

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
What is a ‘Cloud’?

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Definition of Cloud computing
Resource pooling
Elasticity
Mandated by the US Government under the Federal Cloud
Computing Strategy in Feb-2011
Defined by the NIST
5 characteristics:
On-demand self service
Ubiquitous network access
Measured services (SLA)

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Benefits of Cloud computing
Cost-Efficiency
Self-Service
Ubiquitous
Accessibility
#1
#2
#3

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Clinical regulations vs. the Cloud
Same regulatory requirements
All 21 CFR Part 11 rules apply regardless if system is cloud-based, hosted
or on-site:
Your organization (not the Service Provider) is ultimately responsible to
ensure the GxP system is validated, compliant and performs as intended
on the ‘Cloud’.
 Data security & privacy
 Data protection
 Hosting facility controls
 Change management
 Validation

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The contents of this document are confidential and proprietary to Clinovo
Step 1 - Evaluate vendor
 Does vendor have existing customers running GxP applications?
 Does vendor’s staff have all necessary qualification and training?
 Does vendor have a validated instance/template for their hosted application?
 Can the vendor show proof of validation documentation?
 Does the vendor provide 24x7 application support?
Step 2 - Evaluate data safety
 Where exactly will the data be stored and processed?
 Does vendor have sufficient physical and electronic security?
 Is the data communication encrypted over the network?
 Are passwords encrypted when stored?
Clinical regulations vs. the Cloud

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
The Cloud in clinical trials
Empowering Users No IT Dependency
Less planning, faster
implementation and deployment
Simplification of the selection
process for the users

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© 2015 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Self-Service
Platform to deploy
studies
Get started with the Cloud
Free
validated hosting
offer
DIY
CRF builder tool