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What is Cloud Computing? Essentials for Cloud-Based eClinical Applications Contracting with Cloud-Based Technologies Embrace eClinical Cloud-Based Features in Your Procedures
Citation preview
October 31, 2013
Using Cloud-Based Technologies in Clinical Trials:
The Technology and Procedures are both Important
Confidential –
Introduction
Craig brings over 20 years of product development, software engineering and architecture experience, with recent success in population health management, healthcare supply chain management and telecommunications services. Craig spent seven years leading the Technology and Service Delivery organizations at Health Integrated as the Chief Operating Officer and Chief Technology Officer. Previously, he was Chief Technology Officer at Neoforma where he led the development of the NeoConnect™ platform responsible for revolutionizing supply chain connectivity for acute care hospitals. Prior to Neoforma, he was one of the founding engineers of Pharos Technologies and held various technical leadership roles with Centillion Data Systems, Ameritech (AT&T) and E-Span.
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Craig Wigginton
Chief Technology Officer
Confidential –
Introduction
Niki has over 10 years’ of eClinical technology and
Data Management experience, at the vendor, CRO and
biotech levels. Prior to joining DATATRAK, Niki held
positions at Nuron Biotech, Pharm-Olam International,
and ClickFind, Inc.
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Niki Kutac
Product Manager
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Agenda
• What is Cloud Computing?
• Essentials for Cloud-Based eClinical Applications
• Contracting with Cloud-Based Technologies
• Embrace eClinical Cloud-Based Features in Your
Procedures
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Confidential –
What is Cloud Computing?
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Cloud Computing is Everywhere Today
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Technical Definition of Cloud-Computing
► “Cloud computing is a model for enabling ubiquitous,
convenient, on-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.”
---National Institute of Standards and Technology (NIST) U.S
Department of Commerce
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Confidential –
Simple Definition of Cloud-Computing
► “The practice of using a network of remote servers
hosted on the Internet to store, manage, and process
data, rather than a local server or a personal
computer.”
---Oxford Dictionary
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Confidential –
Cloud Jargon Jumble
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► Customers
are often
confused by
what is really
cloud
► Cloud is
• Elasticity
• Scalability
• On-Demand
• Dynamic
Provisioning
• Managed
Upgrades
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Essential Cloud Components
► On-demand self-service • Acquire computing capabilities as needed, without human
interaction or support
► Available Everywhere • Access is provided through standard mechanisms any time,
anywhere on any device
– Mobile phones, tablets, laptops and workstations
► Dynamic Computing Resources • Computing resources are pooled to serve multiple consumers
using a multi-tenant model, with different physical and virtual resources dynamically assigned and reassigned according to consumer demand.
– Examples of resources include storage, processing, memory, and network bandwidth.
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Essential Cloud Components
► Rapid elasticity/Scalability
• Resources may be quickly
provisioned and released when no
longer needed
► Measured service
• Service may leverage metering
capability
• Usage can be monitored,
controlled and reported, providing
high transparency
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Confidential –
Essentials for Cloud-Based eClinical
Applications
► Enterprise Class Security
• Support for current security standards
– PCI DSS, HIPAA, HITECH and SOC 2
• Self-service administration
► Disaster Recovery & Business Continuity
• Ability to maintain availability to serve your business
• Redundant sites, hardware and networks
• Verified business continuity plan
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Confidential –
Essentials for Cloud-Based eClinical
Applications
► Validation
• Ensure consistent on-going performance, security and
integrity of stored and managed data
► Availability & Uptime
• Redundancy to provide users with limited down-time
– Designed to be upgraded while online
– No down-time for mid-study changes
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Key Ingredient – Service Level Agreement
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Service Level
Agreement (SLA)
allows you to manage
the cloud-based vendor
appropriately
Measure what matters
- Availability (99%)
- Support Services
- Response Times
- Service Level Credits
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Cloud-Based
Technologies
open a whole
new world for
Clinical Trial
Management
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Confidential –
With Cloud-Based eClinical
Applications Contracting with CROs &
Sites takes on a SLA like model
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Site Contracting
• Negotiate enforceable
expectations for clinical data
entry into eClinical application
– i.e. Data Entry within 48 hours
of visit
• Payments based on data
quality (no queries or open
issues)
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CRO Contracting
• Negotiate enforceable
expectations for:
– Operational & trial data
entry into eClinical
application
– Data Cleaning Activities
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CRO Contracting
• Move away from time based
unit of measurements to
activity/task based
measurement
• Define the responsibilities and
task associated with the cloud
and who is responsible
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Important Functionality for Cloud-Based eClinical
Applications
• Reports
• Standard & Ad-hoc Reports
• Status Reports on Data Entry & Cleaning
• Ability to see average times to task
• Time between Visit Date & Entry (EDC)
• Time from Query response to Query Close (EDC)
• Time between data received & data entered (CTMS,
eTMF, Safety, Labs)
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Averages Report
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• Record Archival
• Ensure any application provides industry and
regulatory required archival records
• Minimum Integrations
• By selecting a unified (single) database that does
not require integrations (pushing/pulling) of data
provides streamline process
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Important Functionality for Cloud-Based eClinical
Applications
Confidential –
WITH A
CLOUD-BASED
ECLINICAL
APPLICATION
EMBRACE THE
PROCEDURAL
CHANGES
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Embrace eClinical Cloud-Based Features in Your
Procedures
• Real-Time System Responses
– Data Driven Inventory Re-supply Triggers
– Notifications for Serious Adverse Events
– Data Trends
– Quality Issues
• Greater Study Control
– Turn Site Enrollment Off/On
– Views/Permissions
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Embrace eClinical Cloud-Based Features in Your
Procedures
• Real-Time Study Management
– Study Dashboards
– Reports
– Remote Data Review &
Monitoring
• Access the Data from Any Device
– Mobile, Tablet, Laptop or Workstation
• Flexibility of Contracted Resources
– With Cloud-Based Technologies the proximity
of contracted resources is no longer an issue
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In Summary make sure your vendor provides all the
essential components of an eClinical Cloud-Based
Application and have the proper procedures in place
to support the application.
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Confidential – 27
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