Navigation Links
Max Neeman International Expands Data Management Services with Conversion Into CDISC Standard Data Model
Date:6/29/2010

RESEARCH TRIANGLE PARK, N.C., June 29 /PRNewswire/ -- Max Neeman International, India's premier CRO, created a niche in Data Management services and has extended the platform to provide expert CDISC (Clinical Data Interchange Standards Consortium) services and modified solutions which include on-going and legacy clinical data conversion, implementation of CDISC standards and CDISC compliance checks.

CDISC SDTM (Standard Data Tabulation Model) and CRT-DDS (Case Report Tabulation Data Definition Specification) are the standard data models required for submission of tabulation data in the electronic format to the FDA.  FDA uses JANUS clinical data warehouse to store the submitted clinical data and metadata. WebSDM (Web Submission Data Manager) is used to check the compliance of the data with CDISC before loading it.

Max Neeman has established processes for converting the clinical study data available in any format into the standard CDISC SDTM and metadata format which can be submitted to the regulatory authority. The data warehousing facility adds value and renders maximum usability to the existing and legacy data.  

Max Neeman uses SAS and SAS Clinical DI studio for mapping.  There is complete implementation of SDTM compliance checks and ADaM (Analysis Data Model). The company has a dedicated and experienced core SAS Team for CDISC services, well trained by SAS global for effective and efficient execution of the projects.

As stated by the Head of Clinical Data Management, Koteshwar Govind, "We offer a complete Data Management, Biostatistical & CDISC solution to the clinical research/ pharmaceutical industry. Our approach is to fulfill our clients' requirements, deliver solutions which are regulatory-compliant, secure and cost-effective."

About Max Neeman International

Max Neeman International is one of the leading and largest CROs in India. Our specialty is that we offer services for the successful conduct of Phase I-IV clinical and device trials for small and mid-sized international and national Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in compliance with ICH GCP standards. Operational since 2001, Max Neeman is an ISO 9001:2008 certified CRO for Monitoring, Site Management and Data Management Services. The company is presently active in 22 cities with 6 regional offices.  Contact Donald Swankie, Vice President of Business Development via email to donald.swankie@neeman-medical.com or call +1.919.424.3345.  For more information please visit www.neeman-medical.com.


'/>"/>
SOURCE Max Neeman International
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Max Neeman International and AMEDON Collaborate to Increase EDC Performance
2. Max Neeman International Expands Specialized Surgical Team for Clinical Trials
3. Serono Symposia International Foundation in Collaboration With ESHRE Announces Public Competition in Reproductive Medicine
4. Global Pharmaceutical R&D Productivity Declining According to Thomson Reuters, CMR International
5. Bacterin International Secures Three-Year Agreement to Distribute Biologic Products to Broadlanes Network of Over 6,000 Medical Facilities
6. Varian Medical Systems Equips International Oncologys First Comprehensive Cancer Center in India
7. Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results
8. Veteran International Health Care Executive Appointed CEO of BeneChill(R)
9. Abstract Submissions and Registration Now Open for 2nd International Symposium on MR-Guided Focused Ultrasound
10. Systech International and Videojet Brazil Partner to Meet Brazils Emerging Pharmaceutical Regulatory Requirements
11. Drug Production in Afghanistan: A Challenge for the International Community
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)...  This report analyzes the worldwide markets for Chiral ... Products: Intermediates, Analytical, and Others. The End Use ... Agrochemicals. The report provides separate comprehensive analytics for the ... , and Rest of World. Annual estimates and ... Also, a six-year historic analysis is provided for these ...
(Date:2/24/2017)... Research and Markets has announced the addition ... 2016" report to their offering. ... The latest research Urinary Incontinence Drugs Price ... in the global Urinary Incontinence market. The research answers the ... drugs marketed for Urinary Incontinence and their clinical attributes? How are ...
(Date:2/23/2017)... , Feb. 23, 2017  Cogentix Medical, Inc. (NASDAQ: ... markets innovative proprietary products for the urology market, will ... year ended December 31, 2016 before the market open ... Company will host a conference call and webcast to ... March 9, 2017 at 11:00 a.m. Eastern Time (10:00 ...
Breaking Medicine Technology:
(Date:2/24/2017)... Prior Lake MN (PRWEB) , ... February 24, ... ... the launch of its newly designed TaskMate Go. Core benefits and advantages built ... grain finish and a stylish, functional look and feel. Ability to gain the ...
(Date:2/24/2017)... ... February 24, 2017 , ... Dr. Ronald E. ... announced the appointment of Peter A. Bell, DO, MBA, HPF, FACOEP-dist., FACEP, as ... beginning April 10. Dr. Bell comes to Liberty from the Ohio University Heritage ...
(Date:2/24/2017)... , ... February 24, 2017 , ... The narrative in ... Erik Schanssema ’s true account of his paramedic experiences. Schanssema describes the tragedies ... and his attempts to overcome them. , Schanssema, initially unsure of the career ...
(Date:2/24/2017)... ... February 24, 2017 , ... Indiana Fiber Network (IFN) President and CEO ... year. Dyer started as the Chairman of the Management Committee when IFN was ... corporation including the recruitment of investor/owners and development of the business plan. He ...
(Date:2/23/2017)... Austin, TX (PRWEB) , ... February 23, 2017 ... ... has announced an official 2017 partnership with The Jensie Gran Fondo of Marin. ... UVA and UVB rays with Thinksport’s broad-spectrum, mineral-based sunscreen. , “We are thrilled ...
Breaking Medicine News(10 mins):