October 31, 2013

Using Cloud-Based Technologies in Clinical Trials:

The Technology and Procedures are both Important

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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

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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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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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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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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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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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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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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

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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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