Drug Development informatics

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Dwain Allen
5 years ago
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2 Introduction Established in the year 1996 HQ: New Jersey, USA A MakroCare company IT Subsidiary Sole Focus in Life Sciences industry Provides smarter technology for Clinical R&D Multiple customers Small, Mid and Large About Drug Development informatics ISO 9001 (QMS), ISO (ISMS) ISO (Clin. Investigation), ISO (ITSM) DDi. All Rights Reserved.

5 Experience # Clinical Trials 750+ Phase I 50+ ASIA 25% RoW 10% EU 30% Phase II 150+ Phase III 250+ Late Phase/ PMS 300+ USA 35% Therapeutic Areas Oncology Consumer Health Cardiovascular Urology/ Nephrology Infectious Diseases Ophthalmology Diabetes & Endocrinology Orthopedic Vaccines & Biologics Dermatology Pain/ Inflammation Women Health CNS Medical Devices DDi. All Rights Reserved.

6 mclinical Integrated e Clinical suite Web based technologies Single gesg Sign On portal Supports multiple studies Centralized database FDA 21 CFR Part 11 compliance Hosted/ SaaS 24/7 Help Desk Support Value Proposition: Cost-effective, Quick ROI, Faster deployment DDi. All Rights Reserved.

medc Intuitive role based views and displays Supports

Easy ecrf creation, No programming Data exports to SAS,

Dashboard with graphical status reports Different edition

Value Proposition: User friendly, Study setup < 2~3

7 medc Intuitive role based views and displays Supports paper and ecrf studies Core CDM functionalities cto tes Easy ecrf creation, No programming Data exports to SAS, CDISC, Excel English and Japanese language support Dashboard with graphical status reports Different edition for Late Phase, Medical Device studies Device studies Value Proposition: User friendly, Study setup < 2~3 weeks, Low Cost, Optional CDM services DDi. All Rights Reserved.

8 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 multiversion support Import external safety data Custom coding reports Value Proposition: Quick deployment, Shortened coding duration, Integration with other systems DDi. All Rights Reserved.

miwrs Efficient clinical supply management Automated patient

Emergency unblinding Kit allocation & drug re supply Site

management & returns Value Proposition: Easy-to-use interface,

9 miwrs Efficient clinical supply management Automated patient randomization Supports wide range geof ago algorithms Emergency unblinding Kit allocation & drug re supply Site level inventory management Order management & tracking Expiry management & returns Value Proposition: Easy-to-use interface, Highly customizable, Cost effective DDi. All Rights Reserved.

10 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 & Notifications Advanced Search, Custom reports Value Proposition: Cost effective, Quick deployment, Simplicity DDi. All Rights Reserved.

11 Clinical Data Management Core CDM Activities: Data management plan SSingle/Double data entry g e/ oub e data e t y Data analysis Lab data management Lab data management Medical coding Data cleaning/ validation Database Set up Database Set up Data cleaning/ validation Quality check ecrf design Data extraction Edit check development d h kd l CDM Study Set up: Value Proposition: Integrated technical and functional services, Huge cost advantage, Better project management DDi. All Rights Reserved.

12 SAS Clinical Programming Developing project requirements and specifications Building analysis datasets and Case Report Tabulations (FDA CRTs) Derivation of datasets and dgeneration e of TLF Programming tables, listings and figures for regulatory submissions Performing ad hoc programming, reports as requested by statisticians Producing submission ready patient profiles Performing SAS program validation & verification Conversion of raw or derived data sets into CDISC compliant format Implementing and mapping SDTM/ADaM standards d Value Proposition: High skilled, efficient programmers, robust delivery and flexible pricing models DDi. All Rights Reserved.

13 Clinical Metanoia Real time Data Custom Analytics & Reports Collaborative at Portal ota Integrated eclinical Risk Based Monitoring Custom Application Development CDISC and CDASH standardization Big Data Value Proposition: High quality clinical informatics, Quick access to real-time data and analytics, Clinical intelligence with better information and faster decision making DDi. All Rights Reserved.