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SOA and Cloud in Life Sciences

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Presented at Service Tech Symposium 2012 (London September 25th)

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SOA and Cloud in Life Sciences

  1. 1. Examples of SOA and Cloud in Life Sciences Sandeep Bhat Vijay Srinivasan ©2012, Cognizant
  2. 2. Agenda• Industry Observations• Four Technology Focus Areas for Success• Canonical Illustrations• Real World Cases : Four Examples Objectives• Many opportunities for SOA and Cloud in Life Sciences• SOA & Cloud Architectures promote newer business models• Establish and Propagate reusable business services• Create a Smarter Ecosystem
  3. 3. Industry Observations Game-Changing Trends and Massive Information Area Silos Consumerism Patient Centricity, Changing Demographics, Personalized Medicine Build vs. Buy BiopharmaDisintegration of the Value Chain, (Sponsors) M&A, In-licensing Medical Payors / Cost of Innovation Insurance Technology / HIT R&D Investment, Value Differentiation Digitally Enabled Silos Just in Time Researchers Regulators / Care Delivery, Manufacturing Government / Prescribers / Physicians Patients / Pricing Subjects / Caregivers Patent Expiration, Healthcare Reform Commercial Operations Newer Marketing and Sales Models
  4. 4. Four Focus Areas Central to SOA Success Smart Federated Cloud Services Consumerism Build vs. Buy Cost of ServiceGovernance Innovation Oriented Composable Just in Time Services Pricing Commercial Operations Security
  5. 5. The Four Focus Areas • Enable newer business modelsFederated Cloud • High performance services (HPC, Big Data) Architecture • Collaborative “Clouds “ - Harmonize Life Sciences value chains • Reusable and composite services (Personalized patient care, clinical study service, Analytics) verticalized to all Composable facets of the value chain Services • Horizontal composite services – Regulatory Compliance services, secured EMR, federated IAM services . . . • Federated IAM architecture across collaborative Life Sciences “Clouds” Security • Patient EMR – Message Integrity, Message Confidentiality (SAML/WS-Security..) • Governance, Risk, and Compliance : for Audit and Control: 21 CFR Part 11 prescribes to both eSignature and Audit Trails, as when and necessary , functionally Governance • Corporate Integrity and Assurance Functions mandate that processes be institutionalized and Adhered.
  6. 6. Indicative Reference Architecture: On-Premise View Note: This can be and will be technology-orientedLine of Business R D Mf Mk S WEB MOBILITY SOCIAL OPERATIONS/HELP DESKChannelsPresentation WEB NATIVE SOCIALBusiness Processes OPERATIONAL REGULATORY STRATEGICComposite Services TRANSFORMATIO REUSABLE FEDERATED NAL CANONICAL DISTRIBUTEDEntity Services ONTOLOGIES INFORMATION MODEL DATA STORES STATISTICALAnalysis MODELING MASHUPS WORKFLOWStores 1 2 3 4 5
  7. 7. Indicative Reference Architecture: Cloud CommunitiesNote: This will most likely be business function-oriented with a high compliance need Real World Real World Evidence Evidence (OMOP)Simulations Clinical Tests and Biomarkers Simulations Safety Signals Risk Management Medical Sentinel Records Corporate Compliance Multinational and Regulatory Legal Assurance Multiple Agency
  8. 8. CasesTwo Case Studies Two PoVs ©2012, Cognizant
  9. 9. Example 1: Safety Assessment Portal Challenge Global documentation system Documentum Challenges Clinical trials system Oracle DB • Inconsistent user experience • Multiple interfaces Legacy documentation system Documentum • Decentralized security Regulatory reporting system • Scattered information BO • No self service functionality Registry System Oracle DB • Lack of dashboard metrics Product labeling system, Documentum Aggregate reporting system BOClinical reports submission system Oracle DB
  10. 10. Example 1: Safety Assessment Portal ActionProvide a Product Centric view, through a portal, for safety Documents.Provide ability for users to run parameterized reports and to view dashboards
  11. 11. Example 1: Safety Assessment Portal Result Product centric view of Safety documents Enables users to view safety information of products through unified interface Supports common analysis and messaging between documents Minimize duplication, enhance efficiencies
  12. 12. Example 1: Safety Analytics Portal Result (screenshots) Homepage Product Information PageReport Generator NDA Dashboard
  13. 13. Example 2: Clinical Data Repository ChallengeContextFDA’s JANUS repository is a common, standards-based electronic infrastructurethat supports submission, validation, data warehousing, access and analysis ofclinical and non-clinical study data.SDTM is the standard for the submission of data to JANUS. The goal of this effortwas to achieve a set of project objectives:High Level Objective1. Harmonize many different clinical information silos built using different & evolving clinical standards to SDTM2. Create ability to compare and aggregate data across studies and phases3. Ensure consistent application of standards (SDTM) and processes to improve productivity across the Clinical Data Life Cycle4. Enable better collaboration with vendors, partners, and regulatory agencies5. Enable next generation uses; e.g. translation medicine, study design inputs
  14. 14. Example 2: Clinical Data Repository Action 1. Composable Architecture: A Unified Information Model, pulls information from multiple sources 2. Governance and Compliance: 21 CFR Part 11, Version history 3. Future-Proof for Federated Clouds: (e.g.: Genomics) 4. Security
  15. 15. Example 2: Clinical Data Repository Result 1 Metadata Load (ODM) 2 Study level transfer of Metadata 3 Patient data load (SDTM) 4 Populate Metadata History 5 Transfer JANUS to JANUS History 6 JANUS History to SDTM repository 7 SDTM views from SDTM repository 8 SDTM + views (includes supp qualifiers) 9 Error handling service 10 Process logging service 11 Security access layer 12 UI to manage metadata, Data Set Generation and Safety authoring process, Error remediation 13 Encoding service 14 Vocabulary update service 15 Derivation service 16 Service to generate datasets. Freeze service to generate frozen files
  16. 16. Example 3: Investigator Research Centre Portal ChallengeThe TransCelerate Initiative• Shared user interface for an investigator site portal• Mutual recognition of Good Clinical Practice site training and qualification• Risk-based monitoring approach and standards• Clinical data standards for efficacy• A system for ensuring safe and timely supply of comparator drugsMaking a Portal• Two primary communities (Sponsor and Site)• A future community (Subjects/Patients)• Enable the tactical and strategic intents for research• Standardized business functions (composable)• On going and Active collaboration (just-in-time)
  17. 17. Example 3: Investigator Research Centre Portal Two groups intents Tactical Strategic• Study Planning • Simulation• Contract • Virtualization Performance • Labs (Imaging, ECG)• Enrollment • Clinical Experience• Risk Management
  18. 18. Example 3: Investigator Research Centre Portal Action: Indicative Reference ArchitectureKey Architecture Considerations Reusable composite services for core clinical investigational services – Adopt SOA service composition model to reuse functionality across sponsor, site Composite UI Application Model – Aggregate and isolate specific user requirements catering to sponsor, site Reusable composite entity services – Abstract aggregation and assembling of relevant information for multiple data sources – on premise legacy clinical apps/CDRs, ONTOLOGIES, harvest evidence/clinical experiences from life sciences community Clouds
  19. 19. Example 3: Investigator Research Centre Portal Result – FutureApplication of SOA principles• Service Composition through careful adoption of MEPs between service composite and among composition members• Service autonomy expressed thru careful adoption of MEPs and loosely typed operations• Services allow for both REST & SOAP messaging• Vertical and Horizontal service compositions configurable– WS-* Primitives• Shared Portal Services – Composite User Interface ApplicationsMaking the Business Smarter• Greatly improved sponsor efficiencies• Unification with site and true collaboration• A move toward the patient “layer”
  20. 20. Objectives• Many opportunities for SOA and Cloud in Life Sciences• SOA & Cloud Architectures promote newer business models• Establish and Propagate reusable business services• Create a Smarter Ecosystem
  21. 21. Example 4: Clinical Supply Chain Conceptual View Clinical Study Managers, Regulatory Quality Partners Manufacturing Inventory Clinical Ops CRAs, Medical Affairs Assurance (CSOs, CROs) Management Advisors User Groups CMOsReal world outlet Intranet or VPN SSH or DMZ- Internet portal accessed portal enveloped Depots Investigational Product Inventory Management User Interface Country Units, International RA Batch, Shipment Destructi Which Controls, Shelf Life Lot, Time Supplies, on, sites, On Reissue Reports Point, blister or Notificatio External Associations Vendors Demand Tracking Visit vial n Real World Packaging, Reconciliation Sourcing Manufacture Distribution Forecasting Tracking Labeling and Return Commercial Modular Functions and Direct Applications Manufacturing (MRP) Clinical Trial Management EDI Java Web Services ETL Archival Media FTP (CTMS) Interactive Data Exchange Services Randomization (IVRS, IWRS) Master Data Management Subject Investigational (MDM)Randomization Label Supply Demand Facility / Depot Identification Product Core Data In house Associations

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