Mission3 Cloud Webinar - Leveraging the cloud for regulatory affairs & clinical trial collaboration.

+1 602 957 2150
2198 E. Camelback Rd #205
Phoenix, AZ 85016 www.mission3.com
www.clireo.com
Clear Into the Cloud
Pharmaceutical, Biotech, and Medical
Device Company Data in the Cloud
Leveraging the cloud for regulatory affairs
& clinical trial collaboration.

+1 602 957 2150
Dirk K Beth
Managing Director
• Mission3 has been providing cloud software for clinical and regulatory operations since 2007
• Pioneered Regulatory Document Management in the cloud
• #73 fastest growing software company in America 2013 – Inc 5000
• Offices in Munich, Phoenix, Berlin, Rostock
Background

+1 602 957 2150
Webex
Right click on the shared screen
Click “View”
Change to full screen or other to ensure the best screen sharing
Timing
The content of the webinar is about ½ hour and we will take a few questions.
Please use the chat option to ask questions.
Housekeeping

+1 602 957 2150
There is some confusion
about the cloud

+1 602 957 2150
Ninety-five percent of those claiming they never
use the cloud actually do so via online banking
and shopping, social networking, and storing
photos and music.
– Citrix Survey
Background
95%

+1 602 957 2150
National survey showed that most respondents believe the cloud
is related to weather, while some referred to pillows, drugs and
toilet paper.
For Example, 51 percent of respondents, including a majority of
Millennials, believe stormy weather can interfere with cloud
computing.
– Citrix Survey
51%

+1 602 957 2150
Understanding the cloud

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You can either
Build a house or
Rent an apartment

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If you build a house, there are a few
important decisions you have to make…

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How big is
the house?
are you planning
to grow a large
family?
Remodeling addition
typically cost a lot
more once the
house is built

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Once the house is built,
you’re responsible for
Landscaper
Electrician
Plumber
Pay Property Tax
Electricity
Water
Gutter Cleaning
HeatingandCooling
House Keeping
Maintenance
Hire

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How about renting?

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Consider if a
beautiful brand
new apartment
complex in your
city has just
gone up.

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You make fewer,
simpler decisions
You can start with one unit and
grow later, or
downsize

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But…
You do not have a lot of
options to customize your unit

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A unit can easily be
converted
into a 2,3,4 or more units

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The building provide you with
very high quality infrastructure.
The management maintains the
building and the relationships
with the plumbing, electrical,
cable, data and other providers.
And provide several building features
that can be used by all tenants.

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No need to worry about
maintenance cost
No need to Hire landscapers,
electricians, plumbers

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Just pay your rent
Pay as You Go

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As an end-consumer
you’ve been using Cloud for a long time

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you’ve been enjoying
High Reliability Service
Unlimited Storage
Connecting, Sharing

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Why it’s better than
traditional IT

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Supporting Enterprise Software
Stone Wall | Fire-proof | Moat | Army | Dungeon
is like Building
Medieval Fortress

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Requires an Army of IT Engineers
SoftwareUpgrade
Support
Backup/Restore
Service Pack
CustomDevelopment
Network issues

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Let’s Build
An Enormous
Data Center
CapacityPlanning
DisasterPlan
Cooling Management
Server Crashes
Network availability
Physical Access Control

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Many things have
changed

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The enterprise world we live in
2014 and beyond
Global Direct, Open Customers
Communication
Transparency
Work Remotely
Digital Life Convergence
(e.g. Social Media)
(Work and Personal lines are blurring)
(Customers, Resources, IPs are acquired everywhere)
(Mobility Trend)
(Blogs, Social Computing)
Brief Collaboration
(Assemble the best, Disassemble upon completion)

+1 602 957 2150
Can we bridge the gap?

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It Requires
a New Way
of Thinking

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Leave it the experts
who have a lot of money to spend to build
giant datacenters across the globe

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Your data is replicated
3 or 4 times in a cloud data center
High Availability

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Adding Capacity is a
click away or “just
happens”.
Running in just
minutes, not days

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The Cloud automatically balances load
And is Always available

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In many cases you can choose
where your data
and “servers” reside

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Scale up or down – it’s your call
Just reduce your
computing power, storage

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Only a handful of major players
can build
this massive infrastructure

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Limited # line-of-business software providers yet to take
advantage of cloud infrastructure
Smaller number of cloud life
sciences providers

+1 602 957 2150
My Business Needs…
Security
Privacy
Reliability
High Availability
Compliance

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Yes, you’re releasing
some controls
physical security
customization
data integration

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Clearing Up Confusion about
Cloud Computing

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Typical Scenarios
Your company
Software/Service
Providers
Cloud/Infrastructure
Provider
You may also build software
directly on the provider’s platform and
pay them directly

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Do I need to start over?
you could redirect your data to the cloud
Migrate Data to the Cloud
Before

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In some cases,
you could redirect your data to the cloud
After

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However, to take
full advantage, migrate all or
create new apps on the cloud
Employees
Contractors
Consultants

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Multi-tenancy | resource pooling
Self service
Elastic storage
Scale up | down
Pay per use
Ubiquitous network access
Cloud software is written specifically for the cloud

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• No special programming language
• No special hardware
• No cloud magic dust
An intersection of scale, Internet, specific software
solutions that make this work
No Magic Bullet

+1 602 957 2150
Cloud Stratification
Software
as a Service
consume
Platform
as a Service
build
Infrastructure
as a Service
host
Control
higher management overhead
& cost
Abstraction
less IT & lower management costs

+1 602 957 2150
Cloud Computing Taxonomy
Traditional IT
Storage
Servers
Networking
Operation System
Security, Clustering
Virtualization
Data
Applications
Runtime
Youmanage
IaaS
Storage
Servers
Networking
Operation System
Virtualization
Data
Applications
Runtime
Managedbyvendor
Youmanage
Youmanage
PaaS
Managedbyvendor
Storage
Servers
Networking
Operation System
Virtualization
Applications
Runtime
Data
SaaS
Managedbyvendor
Storage
Servers
Networking
Operation System
Virtualization
Applications
Runtime
Data

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TIME
ITCAPACITY
Allocating Resources: The Traditional View
Allocated IT resources
Oversupply
Undersupply
Load
forecast
Initial
investment
Oversupply
Actual load

+1 602 957 2150
TIME
ITCAPACITY
Allocating Resources: The Cloud View
Allocated IT resources Actual load
Lower initial
investment
Less
oversupply
Load
forecast
Less oversupply
No undersupply

+1 602 957 2150
Encryption
Compliance
Audit
Sensitive Data in the Cloud?
Are we there yet?

+1 602 957 2150
Non –
Regulated
Vertical
Industry
Govt /
Defense
Consumer
Requirements for a regulated cloud applications
Life
Sciences
Healthcare Financial
Qualified Platform
Audit
Data Security and Privacy
Industry Specific Compliance
FOIA CFR 21 Part 11 HIPAA PCI, FISMA
Bidirectional encryption
Continuity of Operation
2 Factor
Authentication
Platform

+1 602 957 2150
Private Cloud
A Private Cloud is the creation of a cloud-like environment within an organization’s own
IT infrastructure or at a third party facility. A Private Cloud can provide some of the
financial values of the Cloud while allowing the organization to control security,
governance, availability and reliability.
Private Cloud Benefits
• You control the growth.
• You control the security.
• You can maximize the value of
your capital equipment through
virtualization that reacts to
immediate workload needs,
giving high resource utilization
thus reducing cost.
Private Cloud Risks
• High initial capital needs.
• You must manage growth.
• Assembling the right mix of
infrastructure and virtualization
tools, and the appropriate
procedures to get the full
advantage either internally or by
your Cloud Provider.
• Technology obsolescence.
• Hard to integrate social media.

+1 602 957 2150
Public Cloud Benefits
• Low upfront costs.
• Clear relationship between cost and
benefit with pay-for-use model.
• Easy to try new projects, easy to make
change.
• Flexible.
• A wide choice of Service Level
Agreement choices (SLAs).
• Easy to provide a world-wide presence.
• Access to traditional, service-oriented,
and new Web 2.0 services.
• Easy to integrate social media.
Public Cloud Risks
• Security.
• Performance and availability.
• Can be hard to bring data back in-
house or to another Cloud Service
Provider.
• Long term viability of the Cloud Service
Provider.
• Quality of support.
Public Cloud
The Public Cloud provides resources from a Cloud Service Provider that are
dynamically provisioned on a self-service basis over the Internet, via web-based
applications or web services. The Cloud Service Provider shares resources
among many customers, and bills on a fine-grained utility pricing basis.

+1 602 957 2150
Hybrid Cloud
The Hybrid cloud environment consists of multiple Private Cloud and Public Cloud
environments. By integrating multiple Cloud services, you can take advantage of
Public Cloud services where appropriate and use Private Cloud services where
security, performance or availability constraints require more control.
Hybrid Cloud Benefits
• Maximize operational efficiency and
flexibility of both internal and
external resources.
• Adopt only the best delivery model
for each application or solution.
• Leverage Cloud Bursting and handle
excess demand beyond what a
Private Cloud or your own
infrastructure can handle.
• Lower cost options for disaster
recovery.
Hybrid Cloud Risks
• Moving resources between private
and public Clouds.
• Managing and operational controls.
• Requires expertise and solutions that
function in both Public and Private
Cloud models.

+1 602 957 2150
The IT Perspective
Cloud Benefits AND
Game changers

+1 602 957 2150
Reduced time
to market
Usage-based
costing
More efficient
resource
utilization
Just-in-time
Infrastructure
Almost zero upfront
infrastructure
investment
Business Benefits
of Cloud Computing

+1 602 957 2150
More Efficient
Development Lifecycle,
Improved Testability
Disaster Recovery
and Business
Continuity
Proactive
Scaling
Auto-scaling
Automation –
“Scriptable
infrastructure”
Technical Benefits
of Cloud Computing

+1 602 957 2150
The Cloud is changing the role of System Administrator to a
“Virtual System Administrator”.
The Virtual Administrator

+1 602 957 2150
System Administrators must learn…
• How the business uses the applications today, and tomorrow.
• New deployment methods (virtual machines)
• New models (query parallelization, geo-redundancy and asynchronous
replication),
• Rethink the architectural approach for data
• Leverage different storage options available in the cloud for different types
of datasets.
When architecting future applications, companies need to
encourage more cross-pollination of knowledge between roles
and understand that they are merging.
…Needs Continuing Education

+1 602 957 2150
Keep dynamic data closer to the cloud and static data closer to the
end-user
Where Should My Data Be?
Dynamic
Data
Static Data

+1 602 957 2150
Security should be implemented in every layer of cloud application
architecture.
And What About Security?
Security
Protect Data as it
Moves
Encrypt data as it moves between the
web servers and browsers
With a certificate from an external
authority, the authentication of both
server and browser creates a shared
session key used to encrypt the data in
both directions
Protect Data as it
Rests
If you are concerned about storing sensitive
and confidential data in the cloud, you
should encrypt the data before uploading it
to the cloud

+1 602 957 2150
What does this mean to me?
“Cloud” is actually about SERVICE, not
technology.
It’s not our day job to be hung up on technology.
• Our focus is to ensure the:
» Global delivery of our applications to our end users.
» Sharing of data between systems and users.
» Building of global communities to optimize business processes
and capabilities.
» Meet (and drive) existing and emerging Health Authority
guidance and regulations.
Internal IT becomes more “high value”. Moving from IT to CTO.
From keeping the systems running to ensuring optimal business value.

+1 602 957 2150
Trends in Our Industry
Factors pushing Life
Science companies into
the Cloud
Need to
work with
more virtual
teams
Need to be
more cost
effective
Need to
work with
more global
partners
Need to
better
protect IP
Consumerization
of IT
Need to
be
more
agile
Need more
manageability
of data/docs

+1 602 957 2150
 Collection and cleaning of clinical data.
 High volume simulated data generation to validate
statistical methods.
Gene sequencing processing.
 Offsite datamarts and data storage.
 Collaboration with payers / providers.
Hosting of business applications.
Examples of Cloud Use in Pharma

+1 602 957 2150
Life Sciences Line of Business Applications “Looking for” A
Cloud Home
Non-clinical
• Laboratory Information
Management
• Lab notebook
• Toxicology
Sales and Marketing
• CRM
• Digital Asset Management
• eMPM (Management of
Promotional Materials)
• Sunshine law compliance
Clinical
• CTMS
• EDC
• ePRO
• IVR / IWR
• eTMF
• Secure Global Payments
Safety
• Pharmacovigilence
Regulatory
• Submission Management
• Regulatory Information
Management
• xEVMPD (Europe)
Proprietary information
Patient Information
Time-critical Information
Large Volume Data and Documents
Collaboration Global Access Ease-of-use Speed /
Performance

+1 602 957 2150
 Increased ROI
 Security and Compliance through
Specialized Clouds.
 Established concept matured by
a multitude of industries.
‣ Cloud customers leverage the knowledge and activities performed
by previous tenants to streamline design, deployment, and support.
 Moving the focus from Technology capability, into Application
capabilities.
 Sharing technology platforms unifies the industry, driving the innovation
and evolution of cloud technologies to meet the needs of true, global
organizations in the Life Sciences industry.
Benefits of Cloud Use in Pharma

+1 602 957 2150
Our Future
Global
Accessibility
Collaborative
Environments
Global High-
Availability

+1 602 957 2150
Our Responsibilities
• Define clear and achievable short, medium, and long term requirements
for the technological infrastructure.
• All parties involved in providing the infrastructure should be assessed on
a regular basis to ensure compliance with regulations and business
requirements.
• Ensure change and configuration control procedures are in place at all
levels.
• Ensure proper risk and impact assessment is undertaken when changing
infrastructure.
• UNDERSTAND OUR USERS. Ensure that systems are implemented to
enhance the quality and productivity of user experience; to increase user
adoption, build communities, and retain key talent.

+1 602 957 2150
Thank You
http://www.mission3.com info@mission3.com

Mission3 Cloud Webinar - Leveraging the cloud for regulatory affairs & clinical trial collaboration.

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