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:10/4/2017)... Korea , Oct. 4, 2017  South Korean-based ... next-generation CPR training aide "cprCUBE" on Kickstarter. The device ... compression during cardiac arrests with better efficiency compared to ... also offers real-time feedback on efficacy of the compression ... crowdfunding campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... 2017  AllianceRx Walgreens Prime, the combined central specialty ... pharmacy benefit manager Prime Therapeutics LLC (Prime), today officially ... the unveiling of new signage at its headquarters in ... at a few other company-owned facilities across the country. ... some of whom will begin to see the AllianceRx ...
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
Breaking Medicine Technology:
(Date:10/13/2017)... Calif. (PRWEB) , ... October 13, 2017 , ... Many ... dementia. However, many long-term care insurance companies have a waiver for care if the ... 90-day elimination period, when the family pays for care, is often waived, so the ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Global Healthcare ... scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare ... activity. The fun run is geared towards children of all ages; it is ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has ... today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula ... the highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, ...
Breaking Medicine News(10 mins):