HCL Oracle Life Sciences. 2 Outline Leadership in Life Sciences Life Sciences @ Oracle Universe...

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HCL Oracle Life Sciences

Transcript of HCL Oracle Life Sciences. 2 Outline Leadership in Life Sciences Life Sciences @ Oracle Universe...

Page 1: HCL Oracle Life Sciences. 2 Outline Leadership in Life Sciences Life Sciences @ Oracle Universe HCL’s “ COMPLETE” Offering for Life Sciences Solutions.

HCL Oracle Life Sciences

Page 2: HCL Oracle Life Sciences. 2 Outline Leadership in Life Sciences Life Sciences @ Oracle Universe HCL’s “ COMPLETE” Offering for Life Sciences Solutions.

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Outline

Leadership in Life Sciences

Life Sciences @ Oracle Universe

HCL’s “ COMPLETE” Offering for Life Sciences

Solutions

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HCL Life Sciences – An Overview

Life Sciences Practice

Value Chain

Discovery & Development Regulatory Compliance Manufacturing Sales & Marketing Pharmacovigilence Enterprise IT

Vendor Platforms

ORACLE, SAP & Microsoft TIBCO, WebMethods Cisco AON Lombardi Rockwell Pilgrimsoft’s SmartSolve STAR LIMS, Labware,

abvantage

Highlights

Total Revenues ------- $ 121 M

Consultants ---------------- 1800

LSH Pharma Headcount Split Phama Services Mix (Effort)

EAIEAI

7%7% 3%3%

Package Implementation

54%54% 43%43%

Application Development, Maintenance & Support

Regulatory & Consulting

ADMADM

Lab AutomationLab Automation

Oracle UniverseOracle

Universe

OthersOthersSAPSAP

4%4%

49%49%

8%8%15%15%

17%17%

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HCL in Life Sciences | Did you know?

HCL is working with 10 out of the top 15 global innovator pharma companies 7 out of the top 10 global medical devices companies

HCL is a Leader in Medical Devices Product Development

Has the largest Medical Device Practice Amongst Indian Outsourcers

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Process Consulting

Consolidation

Application Support & Enhancement

Application Dev.& Management

Implementation & Rollout

Design & Blueprint

Target Identification & Validation

Hit Identification Lead Generation

& Optimization Predictive

Computational Chemistry Tools

Lab Automation

Drug DiscoveryManufacturing

& SCM IT

Marketing Management

Sales Force Management

Sales Support Solutions

Consulting CRM

Sales & Marketing

RegulatoryDrug

Development

ERP Middleware Content

Management Consulting Service

Management DW/BI

Enterprise IT

Siebel eClinical

Oracle Clinical Remote Data

Capture LIMS, ELN CDS, SDMS

Preclinical Protocol

Development Clinical Trial

Management Clinical Data

Management Data Analysis Submissions Lab Automation

Preclinical Protocol

Development Clinical Trial

Management Clinical Data

Management Data Analysis Submissions Lab Automation

Validation GAMP5 ASTM

Submission Consultancy Audit Compliance:

ICH USFDA

and related regulations

Validation GAMP5 ASTM

Submission Consultancy Audit Compliance:

ICH USFDA

and related regulations

Procurement Factory

Solutions Enterprise

Solutions Automation

Solutions Consulting MES LEAN

Procurement Factory

Solutions Enterprise

Solutions Automation

Solutions Consulting MES LEAN

Oracle iPharma

MSFT Dynamics

Oracle AERS Siebel AECM eMDR

Oracle Agile OPSM OTM Demantra LIMS, ELN CDS, SDMS

Fusion BEA Aqua Logic Siebel JDE Oracle EBS PeopleSoft CRM On

Demand

AccelerysSchrodingerLIMSELN

Phase ForwardKnowledge base ICH, GCP,

SOPs

Bu

sin

es

s P

roc

es

s O

uts

ou

rcin

g

Remote Infrastructure Services & Data Center

HCL Life Sciences – Service Offerings

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Outline

Leadership in Life Sciences

Life Sciences @ Oracle Universe

HCL’s “ COMPLETE” Offering for Life Sciences

Solutions

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Oracle Technologies

EPM – OBIEE (Siebel Analytics & Hyperion)

SOA & BPMADF and OADatabase 10G/11GApplication Server

Core Packaged Applications

Oracle E-Business Suite 11i, R12i

PeopleSoft 8.3 - 9.1Siebel 7.x - 8.1JD Edwards – XE A9.1

& E1 9.0

Industry Solutions

OPSMBA/BEOC, RDC, TMSARGUS/AERS

New Dimension Applications

OTMAgileHyperionDemantra

HCL Oracle Universe Snapshot

Joint Product Development (OPSM, PS to Oracle Integration)

Deployment & Maintenance T

ec

hn

olo

gie

s

Global Rollout

Implementations, Configuration & Development

Design & Product Blue Print

Application Management/ Operations Consolidation

Upgrade and Migration

Assessment ServicesPa

ck

ag

ed

Ap

pli

ca

tio

n

Oracle Solution Labs (Sandbox & POC) in Chicago and Chennai

Pre-built solutions, IP’s/ Frameworks, Solution Accelerators & reusable components

OPN Lab in Chennai

Strategic Enablers

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HCL Oracle Universe Life Science – Expertise

People

Experience

Comprehensive solutions across the Clinical solutions from Oracle

Siebel Clinical

Oracle Clinical

Remote Data Capture

TMS

AERS, Argus, LSH

Over 70 Consultants in the above solutions

Certified Advantage Partner of Oracle

Leveraging Oracle Partnership

To deliver accelerated solutions to reduce time to deployment and de-risk implementation

Partnering Oracle in expanding the Clinical Solution footprint across markets

70+ Experts in Oracle Pharmaceutical Applications

Right mix of Domain Experts, Functional Consultants and Siebel Technical Consultants

Dedicated CoE for OPA Suite

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HCL Oracle Life Sciences Solution Center

Life Science Business

Competence

Oracle Product Expertise

Tools & Accelerators,

SolutionsMicroverticals

Offerings

Oracle Relationship

Strategic Commitment

Joint Solutions & Go To Market

Co-Development

Product Development & Trials

Sales, Marketing, Customer Service

Mfg, HCM, Finance, SCM

Oracle Clinical, RDC, CTMS, TMS, AERS, Argus Safety Modules, Siebel Clinical

ModulesOracle, PS, JDE ERP;

Oracle, PS, Siebel CRM & entire technology

stack

Life Science Solutions Lab

Accelerated Solutions – iPharma, BA/BE, ICSM

Implementation, Upgrade, Support Accelerators

Pharmaceutical

Bio-tech

Medical Devices

CROs

Perpetual Offerings

Subscription Based Offerings

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Outline

Life Sciences @ Oracle Universe

HCL’s “ COMPLETE” Offering for Life Sciences

Leadership in Life Sciences

Solutions

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Application Maintenance and Support

Application maintenance

L1 helpdesk Support

L2/L3 Support

Hosting Studies

Dictionary Loading

Study Design

Validation

Regulatory validation of OPA installation

Functional Validation

FDA Compliance consultation

Upgrade

Version upgrade

Data migration

Re-implementation

Patch Management

Dictionary Upgrades

HCL Oracle Life Science Service Offerings

Implementation

Package Implementation

Product Integration

End to End Implementation

Functional and Product Training

Oracle Pharmaceutical

Applications

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Enabling customers across all functional areas

Drug Discovery

Drug Development

Manufacturing & SCM IT

Distribution/ Enterprise IT

Sales & Marketing

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Serving customers across all micro-verticals

Pharma/ Biotech

Medical Devices

Biotech

CROs

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Life Sciences @ Oracle Universe

Leadership in Life Sciences

Solutions

HCL’s “ COMPLETE” Offering for Life Sciences

Outline

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Oracle Universe – Life Sciences Solutions

To enhance the productivity of sales force through better visibility & hands-on control on sales process

iPharma

Solution to securely track the BA/BE studies progress in a systematic manner and provides first hand information about the status at any given point in time

BA/BE Solution

For automated submission of regulatory Reports to FDA through Electronic Submissions Gateway

Siebel eMDR Tool

For electronic submission of Adverse Events Reports through FDA’s Electronic Gateway Server

Siebel AERS Tool

To help Pharma companies to comply with gift reporting laws by tracking the spend type in the form of cash, dinners, programs etc to Health Care Professionals

Gift Reporting Tool

Creating Process Integration Packs for Pedigree Solution of Oracle

OPSM

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Reusable Tools & Components

Tool Name Description

Siebel Upgrade Assessment tool Tool for assessing the complexity involved in the "To be Migrated" Siebel version

SmartMigrate Data Migration mapping from multiple source databases to the target database

ELON – Easy Layout Converter This tool converts the web template layout to the GRID Layout

LOV Loader Helps in bulk upload of LOV’s across various environments

Product LoaderTo Upload Product information across environments – along with the class and attribute relationship

EzyMigrate Tools for Migrating static data for standard Siebel entities

Component Monitor This tool monitors specific Siebel Component and Siebel tasks under it

Query Monitor This tool monitors Long running queries in Siebel

CrossFIT It's a Cross platform framework which focus on SOA/ Middleware testing

Password Encryption Encrypts/ Decrypts the password from the COM program connecting to Siebel

EzMerge Bulk merge of duplicate records based on defined criteria

e-Biz Smart Upgrade Upgrade Oracle applications from earlier versions to 11i, R12

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Oracle Universe Differentiators

Platform Based Delivery Model

Integrated solution comprising of Infrastructure services, Application Support services and Oracle CDM services

Charged on a pay as per use basis

Brings down Operational Cost by Minimum 25%

Vertical Solutions

Amongst the first implementation partners to deliver Siebel eMedical AECM

Co-development Partner of Oracle for Pedigree Solutions

Capability in Oracle LS Vertical solutions – Siebel eMedical, ePharma, Oracle CDMS, Oracle RDC, Siebel Compliance Portfolios, Siebel CTMS, Argus

Domain & Technology

Convergence

Developing capability in the Oracle LS solution foot print – Siebel Clinical, Oracle Clinical, Pharma, Medical

Developing point solutions – eMDR Plug In, iPharma, OPSM, BA/BE Solution

Collaborating with the domain experts to develop industry perspective

Niche Services

Implementation Diagnostics

Enterprise wide integration – Leveraging our EAI capabilities and Siebel new EAI technology – JMS

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Case Studies

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Implementation of OC, RDC, TMS

Leading Biotec company – Panacea Biotec

About the Client

Revenues Rs. 23,142 lacs

Operations India

Employees 3200+

Topology Oracle Health Science

Modules

Oracle Clinical 4.5.3

Oracle Thesaurus Management system 4.6

Oracle Remote Data Capture 4.5.3

Business Need

OC upgrade from 4.5.0 to 4.5.3 and TMS upgrade from 4.5.0 to 4.6.0

RDC Implementation (version 4.5.3)

Validation of Environment post-installation (includes Validation of SAS integrated with OC) and delivery of Complete Validation documentation (IQ, OQ, PQ) + SOP’s

Training of additional features of OC and TMS & RDC

Challenges

Data migration from old hardware to new hardware

Migration of Clinical studies from old version to new version of OC and TMS

Creation of a User role based access environment(the previous environment had no user-role based access control)

Designing of RDC training in such a manner that all users have hands-on-user-role based training

Delivered Benefits

Creation of a new secure, cost-effective and validated CDM (OC RDC TMS) environment (test and production both); compliant with global regulatory guidelines

Efficiency gains of 20% and reducing operating costs through Installation of RDC 4.5.3 an EDC application

Complete Validation (IQ,OQ,PQ) documentation enabled company regulatory compliance

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Oracle Clinical, RDC and TMS Implementation

Leading Pharmaceutical company & Leading CRO and Consulting Company – Piramal LifeSciences

About the Client

Revenues Rs. 55 Million

Operations India

Employees 1000+

Topology Oracle Health Sciences

Modules

Oracle Clinical

Remote Data Capture.

Thesaurus Management System

Business Need

Streamline business process to meet regulatory requirements Update the existing Clinical Data Management system Need of a system to monitor the User Activities and Access EDC system is needed to support global trials Tracking and auditing Master Data Changes Integrated solution to manage data across sources and improve visibility

and accuracy

Challenges

No processes were in place in granting and terminating the access to applications

Lack of Automated Tools for tracking User Activities and access, in OC,RDC and TMS

No trained resources for OC,RDC, TMS for customer

Delivered Benefits

By Implementation of OC, RDC and TMS and HCL recommended configurations, company achieved regulatory compliance

Integrated environment for OC,RDC and TMS enabled centralized role based access for the users

Setting up MedDRA and WhoDrug dictionaries enabled industry standard medical coding for studies

All the master data changes have been tracked and audited and process are put in place to track the User Activities and Access

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Oracle Life Sciences Applications Implémentation (OC,RDC,TMS, Siebel CTMS)

Leading Clinical Research Academy in India – Lotus CRA

About the Client

Operations North America, Europe & India

Employees 350+

Topology Oracle Health Science

Modules

Oracle Clinical

Remote Data capture

Thesaurus Management System

Adverse Event Reporting System

Siebel Clinical Trial Management System

Business Need

Integrated solution to manage data across sources and improve visibility and accuracy

Creation of a User role based access environment Configuration and Customisation of system in agreement with specified

User Requirements Computer System and process validation of Oracle Life sciences applications. Complete User and Admin Training for OC,RDC,TMS,AERS and CTMS

Challenges

Existing Clinical Data Management and Pharmacovigilance applications are outdated and desupported

No Integration point between CDM, Pharmacovigilance and CTMS applications Lack of Automated Tools for tracking User Activities and access, for

Oracle Life Sciences applications Identifying and setting up integration points between OC,RDC,TMS AND

AERS

Delivered Benefits

Implementation and Configuration of Oracle Life Sciences Application suite (OC,RDC,TMS,AERS,CTMS)on Production and test/ development environments

Complete Validation (IQ,OQ,PQ etc) documentation enabled company regulatory compliance

Integrated environment for OC,RDC,TMS and AERS

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Oracle-Siebel CRM Pharma Applications Deployment

Global leading Biotherapeutics provider – (CSLB)

About the Client

Revenues $2.78 billion

Operations Headquartered in Melbourne, Australia with operations across 18 countries

Employees 10000

Topology Oracle – Siebel Pharma application; Process Consolidation; 5D development methodology and BIM-OBI Analytics solutions;

Modules

Siebel 8.1.1 ePharma, OBIEE

Business Need

To have 360 degree view of their Customers

Need of a user-friendly, automated global CRM solutions that can execute highly time-sensitive Pharmaceutical, Medical programs

Challenges

Minimize the cost of maintenance and increase user adoption

Provide the client with effectively managed highly scalable projects adhering to strict process guidelines, implementing Best practices – minimize cost of execution while delivering value

Delivered Benefits

Road map for most challenging Global roll out for 18 countries in a single instance is being carried out effectively with the honed skill set

Global Implementation and tightly integrated Pharma application specially tailored to suit all the Business needs. This Implementation provides plethora services to Sales, Marketing, Customer Service, Medical and Business Operations of the client across the globe

Delivered value and reduced costs using our Onsite Offshore methodology, demonstrating effective project management on complex medical programs

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Thank You

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BA/BE Solution Overview

The BA/BE Solution allows drug manufacturing and various clinical research organization

to securely track the BA/BE studies progress in a systematic manner and provides first

hand information about the status at any given point in time. Also provides consolidated

reports for every stage of the study starting from feasibility/ study confirmation till final

report dispatch meeting all regulatory standards including 21 CFR Part 11

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Salient Features

Solution allows tracking of both Clinical flow and Analytical flow of the study

Complete tracking from Feasibility/ Confirmation to Final report dispatch

Supports customization of the different milestones of Clinical and Analytical flow

Includes complex management of Bed and Machine allocation required for the study

System automatically calculates planned dates of each of the milestones depending upon predefine timelines for different studies (Pivotal/ Piliot/ Submission study 1/2/3 analytes)

Consolidated reports for every stage of the study

Meets all relevant regulatory needs including 21CFR Part 11

Reduced license cost as not all Siebel CTMS modules are required for this BA/BE solution

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Highlights

HCL is the first to build BA/BE Solution

Reduced license cost as not all Siebel CTMS modules are required for this BA/BE solution

Completely validated solution and meets all relevant regulatory needs including 21CFR Part 11

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OPSM Application Overview

OPSM is a new Oracle Application built as an extension to existing customer ERP systems (Oracle, SAP, etc.) that enables customers to implement mass-serialization of drug products and share serialized product data across the supply chain in various electronic formats, including electronic pedigree

It is an edge application designed to address drug package serialization capabilities without necessitating full serial tracking in the ERP Transactional system

OPSM architecture will be designed to integrate with customers’ existing manufacturing, shipping and receiving transactional systems

OPSM will be fully integrated for Oracle EBS customers and will be built on open standards to allow integration with other ERP transaction systems, such as Oracle JD Edwards EnterpriseOne, Oracle JD Edwards World, Oracle PeopleSoft Enterprise and SAP

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OPSM Application Overview

# Functionality Features

1 Serialization

Unit and case mass serialization Multi-site provisioning Serial import and export Contract manufacturing serial data exchange Custom serial algorithms

2 Packaging

Web services integration to packaging systems Packaging hierarchy maintenance UI and services Serial and packaging inquiry

3 Shipping

Outbound ePedigree management Shipment and serial analytics Export product data to regulatory database(s)

4 Receiving Inbound ePedigree management BI dashboard drilldown into receipt and serial details

5 Tracking

Portal for customer and consumer serial verification Mobile access Flag counterfeit serials Protect public health

6 Returns Reconciliation

Import returned serials Reconcile serials against sales orders Assess and authorize valid returns Serial disposition

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Operational DashboardsOperational Dashboards

OPSM – Features

User InterfaceUser Interface Web ServicesWeb Services

SerializationSerialization PackagingPackaging

Labeling System

File Transfer

File Transfer

Centralized DB

OPSM

OPSM

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Scope

HCL and Oracle will be engaged in co-development of Process Integration Packs for OPSM and Oracle E-Business Suite (EBS) using AIA foundation and methodology

This Development Project will result in the creation of the following:

# Integration Applications

1AIA PIP OPSM to EBS 11.5.10 Product Serialization & Tracking

OPSM & EBS 11.5.10

2AIA PIPOPSM to EBS 12.1 Product Serialization & Tracking

OPSM & EBS 12.1

3AIA Direct Localized Serialization

OPSM Local to OPSM Enterprise Integration

Co Development

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I-Pharma Solution

Territory Management

Enables efficient Creation, Management & Realignment of Sales Territories of an Organization

Helps to assign Sales Quotas

Call Scheduling

Aids the Sales Rep in Tour Program, Patch Plan & Daily Call Planning

Call Reporting

Enables the Sales Rep to report all his activities in less time & the Management to keep a complete track of sales force activities

Report Analytics

Generates Customized Reports for all levels of Sales Team Aids Management in assessment of performance metrics of Sales team Gives actionable insight into real time data

Expense, Quota & Incentive Management

Generates the monthly & program Expense sheets of reps and managers, Quota vs. Achievement & Incentives

Campaign Management

Helps the Sales & Marketing team to Plan, Execute, Track Budgets & Calculate ROI of campaigns

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I-Pharma Differentiators

Process aligned to multi geo

Pharma requirements

Process aligned to multi geo

Pharma requirements

Customers have proof of concept

on what they will get

Customers have proof of concept

on what they will get

User friendly & Time saving

User friendly & Time saving

Accelerated Implementation at the Customer

site

Accelerated Implementation at the Customer

site

Business ready to sell state of

Siebel CRM solution for

Pharma industry

Business ready to sell state of

Siebel CRM solution for

Pharma industry

HCL’s In-depth Domain & Technical Expertise in CRM

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Siebel eMDR Tool

How do I submit my

regulatory reports

through the FDA ESG

Gateway using Siebel?

HCL’s Siebel eMDR Tool is a plug-in for Siebel AECM module that automates the submission of regulatory reports to FDA through its Electronic Submissions Gateway (ESG)

It populates data from the relevant fields and generates XML stream

It automatically directs the XML Stream to the FDA Gateway and accepts three acknowledgements from FDA

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Siebel eMDR Tool

Siebel AECM

Field Data

FDA Gateway Server(ESG)

CDRH eMDR

HCL’s Siebel eMDR Tool

FDA

1

3

2

XML Stream

1

2

3

Acknowledgement from ESG on message delivery

Acknowledgement from ESG on submission to CDRH

Acknowledgement from CDRH on loading of submission into AE database

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Benefits of Oracle Universe Siebel eMDR Tool

Facilitates

speedy

reporting to

FDA

Automatically accepts and routes FDA

acknowledgements to database

Reporting errors are eliminated as

communication takes place directly with FDA’s ESG Server

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Siebel AERS Tool

Background

FDA has mandated the electronic

submission of Adverse Events Reports

through its Electronic Gateway Server.

This requires industry partners to

voluntarily submit Adverse Event reports

electronically to the FDA.

Description

HCL’s Siebel AERS Tool is a plug-in for Siebel AECM module. Its features are:

Automates the submission of regulatory reports to FDA through its Electronic Submissions Gateway (ESG)

It populates data from fields and generates XML

Automatically directs the XML to FDA Gateway and accepts acknowledgements from FDA

A Snapshot

Business Benefits

Facilitates speedy reporting to FDA

Automatically accepts and routes FDA acknowledgements to database

Guaranteed reporting as communication takes place directly with FDA’s ESG Server

Siebel AECM

Field Data

HCL’s Siebel

AERS Tool

XML

CDER AERS System

1

2

Acknowledgement from ESG on receipt of submission

Acknowledgement by AERS system after the report is processed

Evaluation Center

1

2

FDA Gateway Server(ESG)

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Gift Reporting Tool

Solution Description

US federal governments are coming out with Gift Reporting laws: set by the American Medical Association (AMA)

HCL’s Gift Reporting Solution/ IP

This IP will help track on what counts as a gift

As per the applicable law, the IP will track on all gift, spend type in the form of cash, dinners, programs etc for Health Care Practionners. The IP would help pharma companies to comply with the gift reporting laws

Benefits

The solution will Integrate data from sales, marketing, R & D and finance, and than Process and align the data in a single view of each practitioner wise spend type & amount

Deliver state-level reports that meet the requirements of each state

Proactively monitor and track compliance with state requirements

“Our Solution would help comply with gift reporting laws and regulations”.

Prevent inappropriate gift-giving practices, only sanction gifts valued

at $100 or less