paradigmit - medidata rave services
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CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
Paradigm IT Factsheet
Rapidly growing list of global customers include Fortune 50, Top 10 Global Pharmaceutical
companies and CROs.
Best-in-class Consulting, Technology and high-value/ low-cost Outsourcing Services.
Incorporated in 1998 in Columbia, Maryland, Paradigm is recognized as one of the fastest
growing IT Solutions companies in DC metro area, with a global presence in North America, Asia
and Africa.
With a focus on state-of-the-art IT services, Paradigm developed a niche and expertise in
Electronic Data Capture, Clinical Data Management and offshore outsourcing services.
Robust Information Security and Quality Processes
Off-shore development centre achieved CMMI Level 5 recognition. Strong Process & Quality
Management System - ISO 9001 Certified. State-of-the-art infrastructure with ISO 27001
Certified Information Security Management, and robust BCP & DR site.
Contributing and implementation of Go Green policies and Corporate Responsibility towards
social and ecological aspects are well integrated as a part of Paradigm.
Global Engagements
High-value/Cost-effective
Multi-shore Operation Centers
Flexible off-shore outsourcing models
Community and Environment Responsibility
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
Global Operations and Service Delivery
Empowering Small, Medium and Large enterprises through
value-added services in healthcare
Technology leverage in more than 1000 studies for Top 50 life
sciences organizations
State-of-the-art technology and infrastructure following ISO
9001 and 27001 standards
Successfully undergo and complete audit processes on
behalf of client annually
Reduced cost of operations, travel and on-site monitoring costs
with off-shoring
Shorter lead time for study setup, agile development model for
shorter time-to-market
Best-in-Class Service Delivery & Processes
Audit-ready Global Delivery Practices
Predictable & Tangible Engagement Results
Dedicated Client Emphasis
Team of certified industry professionals; clinical programmers,
developers, with in-house QA, QC team
Best practices approach following 21CFR Part 11, HL7 and
HIPPA compliance
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
CoE – Competency Clinical Study Build
― Requirement analysis
― Clear documentation
― Experienced quality assurance team
― Transparency in process and clear communication of milestones
― Core configuration
― Site administration
― User administration
― eCRF design
― Edit checks build
― Custom functions
― Custom reports development
― Batch upload
― Dry run migration
― Migration
― Data extracts
― Quality control
― Data management
Study Planning
Study Building
Study Execution
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
CoE – Competency in Medidata Rave
Custom Functions
― Study build and development
― Edit Checks and Custom function programming
― Simple, Moderate, Complex checks, and creating derivations
― Extracts development using Dynamic Tabulation Engine
― Developing and deploying configurable datasets
Custom Scripts
― Test scripts creation
― Dry-run execution of the scripts issues
― Rave Web Services (RWS) configurable datasets
― Rave Data Extracts (RDE)
Custom Reports
― Business objects reports development
― Crystal reports development
― Validation Plan & Summary reports
― Dry-run execution of the report issues
Quality Control
― External data load (Lab data & IVRS data)
― Test Execution / QA,UAT Support
― Test data preparation
― Data quality reviews
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
Therapeutic Expertise
● Cardiology/Vascular
● Dermatology
● Gastro Enterology
● Hepatology
● Hematology
● Neurology
● Ophthalmology
● Oncology
● Orthopedics
● Otolaryngology
● Pharmacology/Toxicology
● Rheumatology
● Trauma
● Vaccines
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
Paradigm Key Strengths
● Global Top 10 and Fortune 50 clientele
● Privileged service and technical go-to partner for Medidata over a decade
● EDC capabilities of live data
● Reduction in Clinical Development Costs with utmost quality and training of personnel
on-site on Medidata Rave
● Assistance in development of complex edit checks with best practices
● Over 30 man years’ of experience in study build, edit checks, custom functions, eCRF
development and other Rave integrations (RDE, Configurable Datasets, etc)
● Over 10+ years of experience in building complex studies for various therapeutic areas
and different phases on Medidata Rave
● Variety of roles operated and fulfilled in Rave services, like Designing, Developing,
Programming, Testing, Validation, and Technical Support
● Well-versed and skilled on various Rave modules, such as;
- BU processing - Report Administration
- Standard Reports - Lab Administration
- Site Administration - Configuration Module
- User Administration - Amendment Manager
CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING
Connect with Us
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Copyrights © 2015 ParadigmIT. All Rights Reserved.ParadigmIT, its logo, and Empowering Imagination Into Reality
are trademarks of Paradigm Group
About Paradigm Paradigm Infotech. Inc is a global IT solutions provider to pharmaceutical, bio-tech and healthcare companies focused on deliveringcustomer value through high Quality Processes and Cost-efficient solutions. Paradigm IT Group consists of multiple business units managingdifferent lines of business.
With a global presence and relationship with Fortune 500 companies, the growth has been multi-fold in last decade. With a focus on state-of-the-art IT services, Paradigm developed a niche and expertise in Mobile Technologies, ERP Implementation, Clinical Data Managementand Offshore Outsourcing services.
Simplifying organizational complexities through our processes and methods, refined from several client engagements with our experiencedand credentialed people. By working with strategic partners, using deep industry vertical expertise and delivering on a global scale, we bringthe skills and experience to help you harness next-generation services and solutions to achieve your business objectives and deliver betteroutcomes.
8830 Stanford Blvd, Suite 312, Columbia, MD 21045
For further information contact :
Yasser Mohammad
Business Development – Life Sciences
Email: [email protected]
Phone: + 1 646.851.2615
Mail [email protected] | [email protected]
Phone + 1 646.851.2615
163 West 14th street – Union Station, Erie, PA 16501
Cyber Gateway, ‘B’ Block 2nd Floor, Hitec City, Madhapur Hyderabad
1st Floor, Innovative House 6-3-663/G/4, Panjagutta Hyderabad
USA
INDIA