©2012, Cognizant

Examples of SOA and Cloud in Life Sciences

Sandeep Bhat

Vijay Srinivasan

Agenda

Objectives

• Industry Observations

• Four Technology Focus Areas for Success

• Canonical Illustrations

• Real World Cases : Four Examples

• 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

Consumerism

Patient Centricity, Changing Demographics, Personalized

Medicine

Build vs. Buy

Disintegration of the Value Chain, M&A, In-licensing

Cost of Innovation

R&D Investment, Value Differentiation

Just in Time

Care Delivery, Manufacturing

Pricing

Patent Expiration, Healthcare Reform

Commercial Operations

Newer Marketing and Sales Models

Digitally Enabled Silos

Biopharma (Sponsors)

Medical Technology /

HIT

Researchers / Prescribers / Physicians

Patients / Subjects / Caregivers

Regulators / Government

Payors / Insurance

Industry Observations

Game-Changing Trends and Massive Information Area Silos

Smart Federated

Cloud Services

Service Oriented

Composable Services

Security

Governance

Consumerism

Build vs. Buy

Cost of Innovation

Just in Time

Pricing

Commercial Operations

Four Focus Areas Central to SOA Success

• Enable newer business models

• High performance services (HPC, Big Data)

• Collaborative “Clouds “ - Harmonize Life Sciences value chains

Federated Cloud Architecture

• Reusable and composite services (Personalized patient care, clinical study service, Analytics) verticalized to all facets of the value chain

• Horizontal composite services – Regulatory Compliance services, secured EMR, federated IAM services . . .

Composable Services

• Federated IAM architecture across collaborative Life Sciences “Clouds”

• Patient EMR – Message Integrity, Message Confidentiality (SAML/WS-Security..)

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

• Corporate Integrity and Assurance Functions mandate that processes be institutionalized and Adhered.

Governance

The Four Focus Areas

Indicative Reference Architecture: On-Premise View

Note: This can be and will be technology-oriented

Line of Business

Channels

Presentation

Business Processes

Composite Services

Entity Services

Analysis

Stores 2 1

R D Mf Mk S

4 3 5

WEB MOBILITY OPERATIONS/HELP DESK

WEB NATIVE

SOCIAL

SOCIAL

OPERATIONAL REGULATORY STRATEGIC

TRANSFORMATIO

NAL

REUSABLE FEDERATED

ONTOLOGIES CANONICAL

INFORMATION MODEL

DISTRIBUTED

DATA STORES

STATISTICAL

MODELING MASHUPS WORKFLOW

Indicative Reference Architecture: Cloud Communities

Clinical

Real World Evidence

Tests and Biomarkers

Medical Records

Simulations Safety

Real World Evidence

(OMOP)

Signals

Sentinel

Simulations

Note: This will most likely be business function-oriented with a high compliance need

Regulatory

Risk Management

Multinational

Legal

Multiple Agency

Corporate Compliance

and Assurance

©2012, Cognizant

Cases

Two Case Studies

Two PoVs

Example 1: Safety Assessment Portal

Challenge

Challenges

• Inconsistent user experience

• Multiple interfaces

• Decentralized security

• Scattered information

• No self service functionality

• Lack of dashboard metrics

Global documentation system

Documentum

Legacy documentation system

Documentum

Clinical trials system

Oracle DB

Registry System

Oracle DB

Aggregate reporting system

BO

Clinical reports submission system

Oracle DB

Product labeling system,

Documentum

Regulatory reporting system

BO

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

Example 1: Safety Assessment Portal

Result

Minimize duplication, enhance

efficiencies

Enables users to view safety

information of products through

unified interface

Supports common analysis and

messaging between

documents

Product centric view of Safety documents

Example 1: Safety Analytics Portal

Result (screenshots)

Homepage Product Information Page

Report Generator NDA Dashboard

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

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

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

Example 2: Clinical Data Repository

Result

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)

Two groups intents

Example 3: Investigator Research Centre Portal

Tactical

• Study Planning

• Contract Performance

• Enrollment

• Risk Management

Strategic

• Simulation

• Virtualization

• Labs (Imaging, ECG)

• Clinical Experience

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

Action: Indicative Reference Architecture

Example 3: Investigator Research Centre Portal

Example 3: Investigator Research Centre Portal

Result – Future

Making the Business Smarter

• Greatly improved sponsor efficiencies

• Unification with site and true collaboration

• A move toward the patient “layer”

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

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

External Associations

In house Associations

Data Exchange Services

Core Data

EDI Java Web Services ETL Archival Media FTP

Randomization Supply Subject

Identification

Master Data

Management

(MDM) Investigational

Product Demand Label

Modular Functions and Direct Applications

Sourcing Manufacture Distribution Real World

Tracking

Packaging,

Labeling Forecasting

Reconciliation

and Return

Which

sites,

Vendors

Controls,

On

Demand

Batch,

Lot, Time

Point,

Visit

Shelf Life

Reissue

Tracking

Shipment

Supplies,

blister or

vial

Reports

Destructi

on,

Notificatio

n

Interactive

Randomization

(IVRS, IWRS)

Clinical Trial

Management

(CTMS)

Commercial

Manufacturing

(MRP)

Facility / Depot

Investigational Product Inventory Management User Interface

Real world outlet

- Internet portal

SSH or DMZ

enveloped

Intranet or VPN

accessed portal

User Groups

Regulatory

Affairs

Quality

Assurance

Clinical

Inventory

Management

Manufacturing Clinical Ops

Study Managers,

CRAs, Medical

Advisors

Partners

(CSOs, CROs)

CMOs

Depots

Country Units,

International RA

Example 4: Clinical Supply Chain

Conceptual View