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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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com 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
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www.mission3.com 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 hour and we will take a
few questions. Please use the chat option to ask questions.
Housekeeping
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www.mission3.com There is some confusion about the cloud
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www.mission3.com 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%
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www.mission3.com 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%
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www.mission3.com Understanding the cloud
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www.mission3.com You can either Build a house or Rent an
apartment
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www.mission3.com If you build a house, there are a few important
decisions you have to make
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www.mission3.com 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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www.mission3.com Once the house is built, youre responsible for
Landscaper Electrician Plumber Pay Property Tax Electricity Water
Gutter Cleaning HeatingandCooling House Keeping Maintenance
Hire
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www.mission3.com How about renting?
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www.mission3.com Consider if a beautiful brand new apartment
complex in your city has just gone up.
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www.mission3.com You make fewer, simpler decisions You can start
with one unit and grow later, or downsize
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www.mission3.com But You do not have a lot of options to customize
your unit
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www.mission3.com A unit can easily be converted into a 2,3,4 or
more units
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www.mission3.com 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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www.mission3.com No need to worry about maintenance cost No need to
Hire landscapers, electricians, plumbers
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www.mission3.com Just pay your rent Pay as You Go
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www.mission3.com As an end-consumer youve been using Cloud for a
long time
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www.mission3.com youve been enjoying High Reliability Service
Unlimited Storage Connecting, Sharing
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www.mission3.com Why its better than traditional IT
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www.mission3.com Supporting Enterprise Software Stone Wall |
Fire-proof | Moat | Army | Dungeon is like Building Medieval
Fortress
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www.mission3.com Requires an Army of IT Engineers SoftwareUpgrade
Support Backup/Restore Service Pack CustomDevelopment Network
issues
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www.mission3.com Lets Build An Enormous Data Center
CapacityPlanning DisasterPlan Cooling Management Server Crashes
Network availability Physical Access Control
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www.mission3.com Many things have changed
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www.mission3.com 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)
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www.mission3.com Can we bridge the gap?
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www.mission3.com It Requires a New Way of Thinking
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www.mission3.com Leave it the experts who have a lot of money to
spend to build giant datacenters across the globe
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www.mission3.com Your data is replicated 3 or 4 times in a cloud
data center High Availability
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www.mission3.com Adding Capacity is a click away or just happens.
Running in just minutes, not days
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www.mission3.com The Cloud automatically balances load And is
Always available
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www.mission3.com In many cases you can choose where your data and
servers reside
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www.mission3.com Scale up or down its your call Just reduce your
computing power, storage
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www.mission3.com Only a handful of major players can build this
massive infrastructure
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www.mission3.com Limited # line-of-business software providers yet
to take advantage of cloud infrastructure Smaller number of cloud
life sciences providers
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www.mission3.com My Business Needs Security Privacy Reliability
High Availability Compliance
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www.mission3.com Yes, youre releasing some controls physical
security customization data integration
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www.mission3.com Clearing Up Confusion about Cloud Computing
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www.mission3.com Typical Scenarios Your company Software/Service
Providers Cloud/Infrastructure Provider You may also build software
directly on the providers platform and pay them directly
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www.mission3.com Do I need to start over? you could redirect your
data to the cloud Migrate Data to the Cloud Before
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www.mission3.com In some cases, you could redirect your data to the
cloud After
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www.mission3.com However, to take full advantage, migrate all or
create new apps on the cloud Employees Contractors Consultants
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www.mission3.com 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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www.mission3.com 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
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www.mission3.com 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
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www.mission3.com Cloud Computing Taxonomy Traditional IT Storage
Servers Networking Operation System Security, Clustering
Virtualization Data Applications Runtime Youmanage IaaS Storage
Servers Networking Operation System Security, Clustering
Virtualization Data Applications Runtime Managedbyvendor Youmanage
Youmanage PaaS Managedbyvendor Storage Servers Networking Operation
System Security, Clustering Virtualization Applications Runtime
Data SaaS Managedbyvendor Storage Servers Networking Operation
System Security, Clustering Virtualization Applications Runtime
Data
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www.mission3.com TIME ITCAPACITY Allocating Resources: The
Traditional View Allocated IT resources Oversupply Undersupply Load
forecast Initial investment Oversupply Actual load
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www.mission3.com 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com Encryption Compliance Audit Sensitive Data in the
Cloud? Are we there yet?
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www.mission3.com 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com Private Cloud A Private Cloud is the creation of a
cloud-like environment within an organizations 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.
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www.mission3.com 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.
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www.mission3.com 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com The IT Perspective Cloud Benefits AND Game
changers
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www.mission3.com 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
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www.mission3.com More Efficient Development Lifecycle, Improved
Testability Disaster Recovery and Business Continuity Proactive
Scaling Auto-scaling Automation Scriptable infrastructure Technical
Benefits of Cloud Computing
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www.mission3.com The Cloud is changing the role of System
Administrator to a Virtual System Administrator. The Virtual
Administrator
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www.mission3.com 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
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www.mission3.com Keep dynamic data closer to the cloud and static
data closer to the end-user Where Should My Data Be? Dynamic Data
Static Data
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www.mission3.com 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com What does this mean to me? Cloud is actually about
SERVICE, not technology. Its 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com 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
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www.mission3.com 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
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www.mission3.com 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
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www.mission3.com Our Future Global Accessibility Collaborative
Environments Global High- Availability
+1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016
www.mission3.com Thank You http://www.mission3.com
[email protected]