ddi-overview new sme - clinical, regulatory & automation ... · # clinical trials 750+ eu asia...

Drug Development informatics

www.DDiSmart.comCopyright @ 2013 DDi. All Rights Reserved.

Introduction

Established in the year 1996 HQ: New Jersey, USA

A MakroCare company‐ IT Subsidiary Sole Focus in Life Sciences industry

About

D D l tDrug Development informatics

Provides smarter technology for Clinical R&D Multiple customers – Small, Mid and Large

ISO 9001 (QMS), ISO 27001 (ISMS) ISO 14155 (Clin. Investigation), ISO 20000 (ITSM)

2 www.DDiSmart.comCopyright @ 2013 DDi. All Rights Reserved.

Global Presence


PortfolioText

Clinical Data Management

Text

Services

TextSolutions SAS® Clinical Programming


Experience

# Clinical Trials 750+EU30%ASIA

RoW10%

Phase I 50+

Phase II 150+

25%

Phase III 250+

Late Phase/ PMS 300+USA35%

Therapeutic Areas

Oncology Consumer Health

Cardiovascular Urology/ Nephrology Cardiovascular Urology/ Nephrology

Infectious Diseases Ophthalmology

Diabetes & Endocrinology Orthopedic

Vaccines & Biologics Dermatology

Pain/ Inflammation Women Health


CNS Medical Devices

mClinical

Integrated e‐Clinical suite

Web based technologies

Single Sign‐On portalS g e S g O po ta

Supports multiple studies

Centralized database Centralized database

FDA 21 CFR Part 11 compliance

Hosted/ SaaS Hosted/ SaaS

24/7 Help Desk Support

Value Proposition: Cost-effective, Quick ROI, Faster deployment


mEDC

Intuitive role‐based views and displays

Supports paper and eCRF studies

Core CDM functionalitiesCo e C u ct o a t es

Easy eCRF creation, No programming

Data exports to SAS CDISC Excel Data exports to SAS, CDISC, Excel

English and Japanese language support

Dashboard with graphical status reports Dashboard with graphical status reports

Different edition for Late Phase, Medical Device studiesDevice studies

Value Proposition: User friendly, Study setup < 2~3 weeks, Low Cost, Optional CDM services


Optional CDM services

mCODER

Supports auto and manual coding

Supports WHO‐DD, MedDRA and other medical dictionaries

Browser with advanced search

Upload, upgrade and manage multiple dictionaries with multi‐version support

Import external safety data Import external safety data

Custom coding reports

Value Proposition: Quick deployment, Shortened coding duration, Integration with other systems


Integration with other systems

mIWRS

Efficient clinical supply management

Automated patient randomization

Supports wide range of algorithmsSuppo ts de a ge o a go t s

Emergency unblinding

Kit allocation & drug re‐supply Kit allocation & drug re‐supply

Site level inventory management

Order management & tracking Order management & tracking

Expiry management & returns

Value Proposition: Easy-to-use interface, Highly customizable, Cost effective


effective

mCTMS

Effective study management tool

Centralized repository for multiple studies

Manage global studies, sites, investigators and subjects

Document sharing among all stakeholders

Information tracking Alerts & Information tracking, Alerts & Notifications

Advanced Search, Custom reports Advanced Search, Custom reports

Value Proposition: Cost effective, Quick deployment, Simplicity


Clinical Data Management

Core CDM Activities:

CDM Data management plan

Single/Double data entry CDMS g e/ oub e data e t y

Data analysis

Lab data management

Study Set‐up:

Database Set up

Lab data management

Medical coding

Data cleaning/ validation Database Set‐up

eCRF design

d h k d l

Data cleaning/ validation

Quality check

Edit check development Data extraction

Value Proposition: Integrated technical and functional services, Huge cost advantage, Better project management


cost advantage, Better project management

SAS® Clinical Programming

Developing project requirements and specifications

Building analysis datasets and Case Report Tabulations (FDA CRTs)

Derivation of datasets and generation of TLFe at o o datasets a d ge e at o o

Programming tables, listings and figures for regulatory submissions

Performing ad‐hoc programming reports as requested by statisticians Performing ad‐hoc programming, reports as requested by statisticians

Producing submission‐ready patient profiles

Performing SAS program validation & verification Performing SAS program validation & verification

Conversion of raw or derived data sets into CDISC‐compliant format

l d / d d Implementing and mapping SDTM/ADaM standards

Value Proposition: High skilled, efficient programmers, robust delivery and flexible pricing models


and flexible pricing models

Clinical Metanoia

Real‐time Data

Custom Analytics & Reports

Collaborative PortalCo abo at e o ta

Integrated eClinical

Risk Based Monitoring Risk Based Monitoring

Custom Application Development

CDISC and CDASH standardization CDISC and CDASH standardization

Big Data

Value Proposition: High quality clinical informatics, Quick access to real-time data and analytics, Clinical intelligence with better


real time data and analytics, Clinical intelligence with better information and faster decision making

ddi-overview new sme - clinical, regulatory & automation ... · # clinical trials 750+ eu asia...

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