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

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

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Learn about cloud applications and their life science specific nuances and requirements.

Learn about cloud applications and their life science specific nuances and requirements.

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

    • +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 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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 ½ hour and we will take a few questions. Please use the chat option to ask questions. Housekeeping
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com There is some confusion about the cloud
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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%
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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%
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Understanding the cloud
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com You can either Build a house or Rent an apartment
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    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Once the house is built, you’re responsible for Landscaper Electrician Plumber Pay Property Tax Electricity Water Gutter Cleaning HeatingandCooling House Keeping Maintenance Hire
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com How about renting?
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Consider if a beautiful brand new apartment complex in your city has just gone up.
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com You make fewer, simpler decisions You can start with one unit and grow later, or downsize
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com But… You do not have a lot of options to customize your unit
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com A unit can easily be converted into a 2,3,4 or more units
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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.
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com No need to worry about maintenance cost No need to Hire landscapers, electricians, plumbers
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Just pay your rent Pay as You Go
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com As an end-consumer you’ve been using Cloud for a long time
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com you’ve been enjoying High Reliability Service Unlimited Storage Connecting, Sharing
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Why it’s better than traditional IT
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Supporting Enterprise Software Stone Wall | Fire-proof | Moat | Army | Dungeon is like Building Medieval Fortress
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Requires an Army of IT Engineers SoftwareUpgrade Support Backup/Restore Service Pack CustomDevelopment Network issues
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Let’s Build An Enormous Data Center CapacityPlanning DisasterPlan Cooling Management Server Crashes Network availability Physical Access Control
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Many things have changed
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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)
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Can we bridge the gap?
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com It Requires a New Way of Thinking
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Leave it the experts who have a lot of money to spend to build giant datacenters across the globe
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Your data is replicated 3 or 4 times in a cloud data center High Availability
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Adding Capacity is a click away or “just happens”. Running in just minutes, not days
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com The Cloud automatically balances load And is Always available
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com In many cases you can choose where your data and “servers” reside
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Scale up or down – it’s your call Just reduce your computing power, storage
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Only a handful of major players can build this massive infrastructure
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Limited # line-of-business software providers yet to take advantage of cloud infrastructure Smaller number of cloud life sciences providers
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com My Business Needs… Security Privacy Reliability High Availability Compliance
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Yes, you’re releasing some controls physical security customization data integration
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Clearing Up Confusion about Cloud Computing
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Do I need to start over? you could redirect your data to the cloud Migrate Data to the Cloud Before
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com In some cases, you could redirect your data to the cloud After
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com However, to take full advantage, migrate all or create new apps on the cloud Employees Contractors Consultants
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com TIME ITCAPACITY Allocating Resources: The Traditional View Allocated IT resources Oversupply Undersupply Load forecast Initial investment Oversupply Actual load
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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?
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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 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 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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.
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com The Cloud is changing the role of System Administrator to a “Virtual System Administrator”. The Virtual Administrator
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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. 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 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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
    • +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 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 info@mission3.com