ParadigmIT - Medidata Rave Services

Download ParadigmIT - Medidata Rave Services

Post on 15-Jul-2015




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<ul><li><p>CONSULTING | TECHNOLOGY | SERVICES | STAFFING | OUTSOURCING</p></li><li><p>Paradigm IT Factsheet</p><p>Rapidly growing list of global customers include Fortune 50, Top 10 Global Pharmaceutical </p><p>companies and CROs.</p><p>Best-in-class Consulting, Technology and high-value/ low-cost Outsourcing Services.</p><p>Incorporated in 1998 in Columbia, Maryland, Paradigm is recognized as one of the fastest </p><p>growing IT Solutions companies in DC metro area, with a global presence in North America, Asia </p><p>and Africa. </p><p>With a focus on state-of-the-art IT services, Paradigm developed a niche and expertise in Mobile </p><p>Technologies, ERP Implementation, Clinical Data Management and offshore outsourcing services.</p><p>Robust Information Security and Quality Processes</p><p>Strong Process &amp; Quality Management System - ISO 9001 Certified. State-of-the-art </p><p>infrastructure with ISO 27001 Certified Information Security Management, and robust BCP &amp; DR </p><p>site.</p><p>Contributing and implementation of Go Green policies and Corporate Responsibility towards </p><p>social and ecological aspects are well integrated as a part of Paradigm.</p><p>Global Engagements</p><p>High-value/Cost-effective</p><p>Multi-shore Operation Centers</p><p>Flexible off-shore outsourcing models</p><p>Community and Environment Responsibility</p></li><li><p>Empowering Small, Medium and Large enterprises through value-</p><p>added services in healthcare</p><p>Technology leverage in more than 200 studies for Top 50 life sciences </p><p>organizations </p><p>Team of industry experts, clinical professionals and in-house Quality </p><p>Assurance team</p><p>Best practices approach following 21CFR Part 11, HL7 and HIPPA </p><p>compliance</p><p>State-of-the-art technology and infrastructure following ISO 9001 and </p><p>27001 standards</p><p>End-to-end custom software development, implementation,</p><p>service and maintenance support</p><p>Reduced cost of operations, travel and on-site monitoring costs with </p><p>off-shoring</p><p>Shorter lead time for study setup, agile development model for </p><p>shorter time-to-market</p><p>Best-in-Class Service Delivery &amp; Processes</p><p>Audit-ready Global Delivery Practices</p><p>Global Operations and Service Delivery</p><p>Predictable &amp; Tangible Engagement Results</p><p>Dedicated Client Emphasis</p></li><li><p>Clinical Service Areas</p><p>Statistical Analysis</p><p> Develop statistical analysis plan</p><p> Define, program and validation of tables, </p><p>listings and graphs</p><p> Statistical analysis and report for DSMB</p><p> Final TLGs</p><p> Final statistical report at the end of study</p><p>Quality Assurance</p><p> Data management audit</p><p> Checking compliance for 21 CFR part 11, </p><p>HIPAA, CDISC and CDASH standards</p><p> Regular audit reports, data back-up and </p><p>archival, security measures and </p><p>risk management</p><p>Clinical Data Management</p><p> CRF design specifications (contents from protocol)</p><p> CRF planning and approval meeting</p><p> CRF screenshots and final CRFs development </p><p> Generation of CRF completion instructions, self-evident correction and quality assurance error rate documents</p><p> Database design, development, and validation</p><p> Generation of Data Management Plan (DMP) and Data Validation Plan (DVP)</p><p> Development, programming and validation of edit specification documents (CF and Edit Checks)</p><p> Data back-up, archival, preparation of CRF CD for all sites and studies</p><p> Diary reconciliation, central lab reconciliation &amp; data transfers</p><p> Development, programming and review of data review listings for clinician &amp; statisticians</p><p> Database Lock : final database freeze/closeout and locking activities</p><p>EDC Support Services</p><p> EDC system training to site coordinators</p><p> EDC study specific training</p><p> Training of investigators on EDC</p><p> Administration of investigator sites, user </p><p>roles and rights</p><p> Study specific customizations</p><p> System administration</p><p> Management of query resolution</p><p> Electronic transfer of data and documents</p></li><li><p>CoE Competency in Medidata Rave </p><p>Custom Functions</p><p> Study build and development</p><p> Edit Checks and Custom function programming</p><p> Simple, Moderate, Complex checks, and creating derivations</p><p> Extracts development using Dynamic Tabulation Engine</p><p> Developing and deploying configurable datasets </p><p>Custom Scripts</p><p> Test scripts creation </p><p> Dry-run execution of the scripts issues</p><p> Rave Web Services (RWS) configurable datasets</p><p> Rave Data Extracts (RDE)</p><p>Custom Reports</p><p> Business objects reports development</p><p> Crystal reports development</p><p> Validation Plan &amp; Summary reports</p><p> Dry-run execution of the report issues </p><p>Quality Control</p><p> External data load (Lab data &amp; IVRS data)</p><p> Test Execution / QA,UAT Support</p><p> Test data preparation</p><p> Data quality reviews </p></li><li><p>More than a platform : A clinical research eco-systemG L O B A L S TAT I S T I C S</p><p>200,00 sites</p><p>130 countries</p><p>400 organizations worldwide</p><p>2 million trial volunteers</p><p>9, 000 trials</p></li><li><p>What makes us Unique</p><p>Privileged service and technical go-to partner for Medidata</p><p>Over 10+ years of experience in study build with Medidata Rave</p><p>Delivered Rave services to fortune 50 Pharmaceutical companies and </p><p>CROs</p><p>Catering a unique and rare skill set of services like Medidata Rave Custom </p><p>Function Programming and Custom Reports Programming validated by </p><p>in-house QC team</p><p>Variety of roles operated and fulfilled in Rave services, like Designing, </p><p>Developing, Programming, Testing, Validation, Data Management, and </p><p>Technical Support</p><p>Well-versed and skilled on various Rave modules, such as;</p><p>- Dynamic Tabulation Engine - Report Administration</p><p>- Standard Reports - Lab Administration</p><p>- Site Administration - Configuration Module</p><p>- User Administration</p></li><li><p>Client Speak</p><p>Guys...nicely done in bringing 2 complex oncology studies</p><p>live precisely 6 weeks from PIM, on a new URL. Actually, this</p><p>is bordering on the spectacular.</p><p>Special kudos to the Project Managers...both executing nicely</p><p>on some pretty lean and stressful timelines. This is a</p><p>testament to teamwork and to good, solid planning and</p><p>execution.</p><p>Fortune 500 Therapeutics based company</p><p>I want you to know how much I appreciated the extra time</p><p>and quality work that the team has put in getting the custom</p><p>script developed, tested and released for execution.</p><p>We are extremely satisfied with your work, responsiveness</p><p>and assistance. By providing the extra efforts, you guys</p><p>showed the level of customer orientation and by doing so</p><p>strengthen the relationship between us.</p><p>Fortune 100 Global Top 5</p><p>Biotechnology based Company</p><p>I wanted to bring this to your attention. We recently went live</p><p>with a custom Rave to IMPACT integration. You guys were</p><p>critical players in this effort. It is no small accomplishment, I</p><p>assure you.</p><p>The technical expertise and professionalism exhibited by your</p><p>team has been recognized and thoroughly appreciated for</p><p>bringing the project over the finish line.</p><p>Fortune 100 Global Top 5 </p><p>Healthcare &amp; Bio-Pharmaceutical Company</p><p>Rated over 90% for overall performance, customer satisfaction, </p><p>analytical and technical skills, deliverability and in meeting </p><p>deadlines</p><p>Global CTMS provider</p></li><li><p>India</p><p>Cyber Gateway, B Block, 2nd Floor, Hitec City, Madhapur, Hyderabad, Telangana, IndiaPhone: +91 40 44446000, + 91 40 44446027 Fax: 91-040-23319866</p><p>Plot No 2, Hill No 3, IT HUB, Madhurawada, Visakhapatnam 530041, Andhra Pradesh, India</p><p>N-161A, 2nd Floor, Saira Tower, Gulmohar enclave, Yusuf Sarai, Near Green Park Metro Station, New Delhi, 110049. India</p><p>United States</p><p>8830 Stanford Blvd, Suite 312, Columbia, MD 21045Phone:+1 410 872 1008 Fax:+1 410 872 9396</p><p>163 West 14th street Union Station, Erie, PA 16501Phone: +1 (814) 8367801 Fax: +1 (814) 836 7803</p><p>Copyrights 2014 ParadigmIT. All Rights Reserved.ParadigmIT, its logo, and Empowering Imagination Into Reality </p><p>are trademarks of Paradigm Group</p><p>w w w . p a r a d i g m i t . c o m</p><p>Connect with Us</p></li></ul>


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