Drug Development informatics
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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)
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Global Presence
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PortfolioText
Clinical Data Management
Text
Services
TextSolutions SAS® Clinical Programming
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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
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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
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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
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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
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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
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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
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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
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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
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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
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real time data and analytics, Clinical intelligence with better information and faster decision making
Thank YouThank You
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