paradigmit - medidata rave services

8

Click here to load reader

Upload: yasser-mohammad

Post on 15-Jul-2015

215 views

Category:

Healthcare


4 download

TRANSCRIPT

Page 1: ParadigmIT - Medidata Rave Services

CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING

Page 2: ParadigmIT - Medidata Rave Services

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

Page 3: ParadigmIT - Medidata Rave Services

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

Page 4: ParadigmIT - Medidata Rave Services

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

Page 5: ParadigmIT - Medidata Rave Services

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

Page 6: ParadigmIT - Medidata Rave Services

CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING

Therapeutic Expertise

● Cardiology/Vascular

● Dermatology

● Gastro Enterology

● Hepatology

● Hematology

● Neurology

● Ophthalmology

● Oncology

● Orthopedics

● Otolaryngology

● Pharmacology/Toxicology

● Rheumatology

● Trauma

● Vaccines

Page 7: ParadigmIT - Medidata Rave Services

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

Page 8: ParadigmIT - Medidata Rave Services

CONSULTING | TECHNOLOGY | OPERATIONS | STAFFING | OUTSOURCING

Connect with Us

w w w . p a r a d i g m i t . c o m

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