Navigation Links
Max Neeman International Expands Data Management Services with Conversion Into CDISC Standard Data Model

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 or call +1.919.424.3345.  For more information please visit

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:
(Date:6/24/2016)... , June 24, 2016 Research ... World Market for Companion Diagnostic Tests" report to their ... Market for Companion Diagnostics The World Market ... and personalized medicine diagnostics. Market analysis in the report includes ... Test Market (In Vitro Diagnostic Kits) by Region (N. America, ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic ... World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. ... some of the world’s leading providers of cereal and other breakfast foods. Its residents ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
Breaking Medicine News(10 mins):