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 [email protected] or call +1.919.424.3345. For more information please visit www.neeman-medical.com.
SOURCE Max Neeman International
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