This document provides examples of how service-oriented architecture (SOA) and cloud computing can be applied in the life sciences industry. It discusses four key focus areas - federated cloud architecture, composable services, security, and governance. It then provides four examples: 1) a safety assessment portal that consolidates safety documents, 2) a clinical data repository that harmonizes data standards, 3) an investigator research center portal that enables collaboration between sponsors and sites, and 4) a clinical supply chain concept that tracks investigational products. The examples illustrate how SOA and cloud can help address industry challenges and create reusable services.

1. Examples of SOA and Cloud
in Life Sciences
Sandeep Bhat
Vijay Srinivasan
©2012, Cognizant

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. Industry Observations
Game-Changing Trends and Massive Information Area Silos
Consumerism
Patient Centricity, Changing
Demographics, Personalized
Medicine
Build vs. Buy
Biopharma
Disintegration 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. Four Focus Areas Central to SOA Success
Smart
Federated
Cloud
Services
Consumerism
Build vs. Buy
Cost of Service
Governance
Innovation Oriented
Composable
Just in Time Services
Pricing
Commercial
Operations
Security

5. The Four Focus Areas
• Enable newer business models
Federated 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. Indicative Reference Architecture: On-Premise View
Note: This can be and will be technology-oriented
Line of Business R D Mf Mk S
WEB MOBILITY SOCIAL OPERATIONS/HELP DESK
Channels
Presentation WEB NATIVE SOCIAL
Business Processes OPERATIONAL REGULATORY STRATEGIC
Composite Services TRANSFORMATIO REUSABLE FEDERATED
NAL
CANONICAL DISTRIBUTED
Entity Services ONTOLOGIES
INFORMATION MODEL DATA STORES
STATISTICAL
Analysis MODELING
MASHUPS WORKFLOW
Stores 1 2 3 4 5

7. Indicative Reference Architecture: Cloud Communities
Note: 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. Cases
Two Case Studies
Two PoVs
©2012, Cognizant

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
BO
Clinical reports submission system
Oracle DB

10. Example 1: Safety Assessment Portal
Action
Provide a Product Centric view, through a portal, for safety Documents.
Provide ability for users to run parameterized reports and to view dashboards

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. Example 1: Safety Analytics Portal
Result (screenshots)
Homepage Product Information Page
Report Generator NDA Dashboard

13. Example 2: Clinical Data Repository
Challenge
Context
FDA’s JANUS repository is a common, standards-based electronic infrastructure
that supports submission, validation, data warehousing, access and analysis of
clinical and non-clinical study data.
SDTM is the standard for the submission of data to JANUS. The goal of this effort
was to achieve a set of project objectives:
High Level Objective
1. Harmonize many different clinical information silos built using different &
evolving clinical standards to SDTM
2. Create ability to compare and aggregate data across studies and phases
3. Ensure consistent application of standards (SDTM) and processes to
improve productivity across the Clinical Data Life Cycle
4. Enable better collaboration with vendors, partners, and regulatory agencies
5. Enable next generation uses; e.g. translation medicine, study design inputs

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. 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. Example 3: Investigator Research Centre Portal
Challenge
The 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 drugs
Making 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. 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. Example 3: Investigator Research Centre Portal
Action: Indicative Reference Architecture
Key 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. Example 3: Investigator Research Centre Portal
Result – Future
Application 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 Applications
Making the Business Smarter
• Greatly improved sponsor efficiencies
• Unification with site and true collaboration
• A move toward the patient “layer”

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. 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
CMOs
Real 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