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:10/2/2017)... 2, 2017  Eli Lilly and Company (NYSE: ... the third quarter of 2017 on Tuesday, October 24, ... that day with the investment community and media to ... conference call will begin at 9 a.m. Eastern time. ... live webcast of the conference call through a link ...
(Date:10/2/2017)... 2017 The Rebound mobile app is poised to ... the tide of prescription drug addiction. The app empowers users ... and stepping down their dosage in a safe, controlled manner ... 2017; the first 100,000 people to sign up will enjoy ... ...
(Date:9/27/2017)... -- Commended for their devotion to personalized service, SMP Pharmacy Solutions ... in the South Florida Business Journal,s 50 Fastest-Growing Companies, and ... the national specialty pharmacy has found its niche.  To that ... be honored by SFBJ as the 2017 Power Leader in ... receive his award in October, Bardisa said of the three ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... MD (PRWEB) , ... October 12, 2017 , ... The ... of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual ... – 8. , In honor of Morris F. Collen, a pioneer in the field ...
(Date:10/12/2017)... ... 2017 , ... Leading pediatric oncology experts at Children’s National Health System ... Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by ... and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of ...
Breaking Medicine News(10 mins):