paradigmit - medidata rave services

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  • CONSULTING | TECHNOLOGY | SERVICES | 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 Mobile

    Technologies, ERP Implementation, Clinical Data Management and offshore outsourcing services.

    Robust Information Security and Quality Processes

    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

  • Empowering Small, Medium and Large enterprises through value-

    added services in healthcare

    Technology leverage in more than 200 studies for Top 50 life sciences

    organizations

    Team of industry experts, clinical professionals and in-house Quality

    Assurance team

    Best practices approach following 21CFR Part 11, HL7 and HIPPA

    compliance

    State-of-the-art technology and infrastructure following ISO 9001 and

    27001 standards

    End-to-end custom software development, implementation,

    service and maintenance support

    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

    Global Operations and Service Delivery

    Predictable & Tangible Engagement Results

    Dedicated Client Emphasis

  • Clinical Service Areas

    Statistical Analysis

    Develop statistical analysis plan

    Define, program and validation of tables,

    listings and graphs

    Statistical analysis and report for DSMB

    Final TLGs

    Final statistical report at the end of study

    Quality Assurance

    Data management audit

    Checking compliance for 21 CFR part 11,

    HIPAA, CDISC and CDASH standards

    Regular audit reports, data back-up and

    archival, security measures and

    risk management

    Clinical Data Management

    CRF design specifications (contents from protocol)

    CRF planning and approval meeting

    CRF screenshots and final CRFs development

    Generation of CRF completion instructions, self-evident correction and quality assurance error rate documents

    Database design, development, and validation

    Generation of Data Management Plan (DMP) and Data Validation Plan (DVP)

    Development, programming and validation of edit specification documents (CF and Edit Checks)

    Data back-up, archival, preparation of CRF CD for all sites and studies

    Diary reconciliation, central lab reconciliation & data transfers

    Development, programming and review of data review listings for clinician & statisticians

    Database Lock : final database freeze/closeout and locking activities

    EDC Support Services

    EDC system training to site coordinators

    EDC study specific training

    Training of investigators on EDC

    Administration of investigator sites, user

    roles and rights

    Study specific customizations

    System administration

    Management of query resolution

    Electronic transfer of data and documents

  • 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

  • More than a platform : A clinical research eco-systemG L O B A L S TAT I S T I C S

    200,00 sites

    130 countries

    400 organizations worldwide

    2 million trial volunteers

    9, 000 trials

  • What makes us Unique

    Privileged service and technical go-to partner for Medidata

    Over 10+ years of experience in study build with Medidata Rave

    Delivered Rave services to fortune 50 Pharmaceutical companies and

    CROs

    Catering a unique and rare skill set of services like Medidata Rave Custom

    Function Programming and Custom Reports Programming validated by

    in-house QC team

    Variety of roles operated and fulfilled in Rave services, like Designing,

    Developing, Programming, Testing, Validation, Data Management, and

    Technical Support

    Well-versed and skilled on various Rave modules, such as;

    - Dynamic Tabulation Engine - Report Administration

    - Standard Reports - Lab Administration

    - Site Administration - Configuration Module

    - User Administration

  • Client Speak

    Guys...nicely done in bringing 2 complex oncology studies

    live precisely 6 weeks from PIM, on a new URL. Actually, this

    is bordering on the spectacular.

    Special kudos to the Project Managers...both executing nicely

    on some pretty lean and stressful timelines. This is a

    testament to teamwork and to good, solid planning and

    execution.

    Fortune 500 Therapeutics based company

    I want you to know how much I appreciated the extra time

    and quality work that the team has put in getting the custom

    script developed, tested and released for execution.

    We are extremely satisfied with your work, responsiveness

    and assistance. By providing the extra efforts, you guys

    showed the level of customer orientation and by doing so

    strengthen the relationship between us.

    Fortune 100 Global Top 5

    Biotechnology based Company

    I wanted to bring this to your attention. We recently went live

    with a custom Rave to IMPACT integration. You guys were

    critical players in this effort. It is no small accomplishment, I

    assure you.

    The technical expertise and professionalism exhibited by your

    team has been recognized and thoroughly appreciated for

    bringing the project over the finish line.

    Fortune 100 Global Top 5

    Healthcare & Bio-Pharmaceutical Company

    Rated over 90% for overall performance, customer satisfaction,

    analytical and technical skills, deliverability and in meeting

    deadlines

    Global CTMS provider

  • India

    Cyber Gateway, B Block, 2nd Floor, Hitec City, Madhapur, Hyderabad, Telangana, IndiaPhone: +91 40 44446000, + 91 40 44446027 Fax: 91-040-23319866

    Plot No 2, Hill No 3, IT HUB, Madhurawada, Visakhapatnam 530041, Andhra Pradesh, India

    N-161A, 2nd Floor, Saira Tower, Gulmohar enclave, Yusuf Sarai, Near Green Park Metro Station, New Delhi, 110049. India

    United States

    8830 Stanford Blvd, Suite 312, Columbia, MD 21045Phone:+1 410 872 1008 Fax:+1 410 872 9396

    163 West 14th street Union Station, Erie, PA 16501Phone: +1 (814) 8367801 Fax: +1 (814) 836 7803

    Copyrights 2014 ParadigmIT. All Rights Reserved.ParadigmIT, its logo, and Empowering Imagination Into Reality

    are trademarks of Paradigm Group

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

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