Drug Development informaticsDrug Development informaticsOverview

A MakroCare DivisionCONFIDENTIAL

Introduction

About Us

Established: 1996 (HQ : NJ, USA)

World class Drug Development, Consulting  and Commercial services provider

Multiple life science customers, including 8 of the TOP 15

ISO 9001, 14155, 27001 and 20000 certified

Multiple awards: 3 time TOP 500 growth company in North America, 3 time INC 5000 company and NJ Finestp y

Best “Biotech Support” award for 2009/2011 from US Commerce

Compliance/ Standards ‐ GxP, cTQM, PMI, 21 CFR Part 11, CDISC, HIPAA, HL7, pGAMP5, ITIL

Global Presence

Clientele

Portfolio

mClinicalBI & Data 

WarehousingOracle Health 

Application Integration

Warehousing

Content 

Sciences

Clinical InfoManagement & Portals

Clinical Info FrameworkSystem 

Validation

mClinical Product Suite

mClinical An integrated suite of web based e‐clinical technologies

A web based data capture and clinical data management system forp g ymanaging single or multi‐site clinical studies with complete audittrail.

A di l di t l id lti l l d lti iA medical coding tool, provides multi‐level and multi‐versiondictionary support for industry standard WHO‐DD, MedDRA andother dictionaries.

A web‐based trial management application to manage all clinicaloperations involving large amounts of data through a centralizedrepository.p y

A simple and robust web application for centralized patientrandomization. It supports open‐label, single‐blind and double‐blind

d i ti i lti t dirandomizations in multi‐arm studies.

Other e‐Clinical productspA secured web‐based clinical research management tool withrobust document management and collaborative portal features. Itallows all stakeholders involved in a clinical research to connectallows all stakeholders involved in a clinical research to connect,share, communicate and collaborate in an effective and securedmanner.

A web based simple task management tool with configurableworkflows and easy tracking functionality, supports multipleprojects and issue types.

IT Solutions

IT Capabilities

Oracle Microsoft Open  OthersOracle Microsoft

NET (C# VB

source

h

Others

Oracle Health Sciences

.NET (C#,  VB, ASP, ADO)

Apache 

PHP

SAS

XML/ SOAP/

Oracle 10g/ 11i

SharePoint

MS SQL

MySQL

Li

XML/ SOAP/ HTTP

PL/SQL

MS SQL Server

Linux

Java/ J2EE

CRM

PL/SQLBI Tools CMS

ERP

Technology SolutionsTechnology Solutions

• 3rd Party e-Clinical System Implementation and Migration

Clinical Info Framework

y y p g• Custom Application Development

• CDISC and CDASH implementation

Data conversion to CDISC standardsClinical Info Framework • Data conversion to CDISC standards

• Custom Report Development

• Business Process Re-engineering

• OPN (OC, RDC, TMS, AERS) ( , , , )

• Implementation, Upgradation, Migration

• System Validation, Regulatory Compliance, IT Audit

Integration with 3rd party systemsOracle Health Sciences • Integration with 3rd party systems

• Help Desk & Support

• Data migration/ conversion & custom report development

• Software Licensing, Hosting, On-Demand Solutions

Technology SolutionsTechnology Solutions

• Validation Strategy & Planning

System Validation

• Regulatory Compliance Assessment

• Remediation Planning

• IQ, OQ and PQSystem Validation Q, Q Q

• Test Case Authoring and Execution

• Development of SOPs

Document & Record management

Content Management and

• Document & Record management

• Enterprise Content management

• Business process managementContent Management and

Portals• Portal development & Custom workflows

• Scanning (image and capture)

Technology SolutionsTechnology Solutions

• Extract, Transform and Load (ETL)

Business Intelligence

• Decision support systems

• Data mining, Query and reporting

• Online Analytical Processing (OLAP) and Data Warehousing

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• Dashboards and Scorecards

• Forecasting and Statistical Analysis

• Enterprise Application Integration (EAI)• Enterprise Application Integration (EAI)

• Business to Business Integration (B2B)

• Legacy Application Integration

Application Integration • 3rd Party e-Clinical System Integration: EDC, CTMS, IWRS/ IVRS, ePRO, Drug Safety Systems, Auto coding Systems

• Service Oriented Architecture (SOA) & Cloud Computing

Value Addition

CDM

Statistics

PV R lPV Regulatory

QA Clinical Ops

SMO Consulting Medical Writing

Integrated Functional Services

CDM Data management plan

Biostatistics Protocols development

Medical Writing CSR, Protocol, IB, ICFg p

Paper CRF/ eCRF design

Edit check development

p

Sample size calculations

Statistical analysis plans

, , ,

Narrative Writing, INDs, NDAs, ANDAs, BLAs, IMPDs, SmPCs

Double data entry

Data analysis

Randomization

SAS programming 

Annual/Periodic Safety Reports ‐ INDARs, PADERs, CTSURs, PSURs

Lab data management

Medical coding

Statistical analysis & reports

Preparing and analyzing ISS/ ISE d b

Publications, Journal Writing

Abstracts, Synopses

Data cleaning/ validation

Quality check

ISE databases

Conducting data mining and exploratory analysis

Literature Reviews

Manuscripts

Data extractionp y y

Why DDi?

Global drug development partner

In‐depth domain expertise

Technology competency

EDC and CDM Center of Excellence

Integrated clinical and technology services

Flexible pricing and delivery models

Successful track record

24/7 helpdesk & multi‐lingual support

Th k Y !Thank You!

A MakroCare DivisionCONFIDENTIAL