Leading India-USA based CRO Announces Data Management/EDC, Medical Writing Milestone

RESEARCH TRIANGLE PARK, N.C., July 23, 2012 /PRNewswire/ -- Max Neeman International announced today that they have provided Data Management services to over 60 countries and have completed 250 Medical Writing projects; key milestones for the company since it began operations in 2001.

Outsourcing of clinical research services, such as Data Management/EDC and Medical Writing, continues to grow as Sponsors seek quality, reliable results that are more cost-effective. Max Neeman has an exceptional talent pool of more than 110 ICH GCP trained professionals in Data Management and Medical Writing, having domain expertise and 5-10 years of experience.

Koteshwar Govind, Head of Clinical Data Management states, "Reaching over 60 countries with our Data Management, Biostatistical and CDISC solutions is very fulfilling and a testament to the company's customer-driven, customized approach. Independent of whether we run the trial or not, we can provide exemplary Data Management services that every clinical research trial needs. Solutions delivered are regulatory-compliant, secure and cost-effective." 

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. We also have well established processes for converting existing clinical study data [Legacy Data] 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.

In addition to providing Data Management services on Ph I-IV drug and medical device trials, Max Neeman International has been a trusted partner of numerous global pharmaceutical, biotech and device companies for Medical Writing services. The Medical Writing team at Max Neeman, all with a scientific degree [Master's or PhD], and experience in scientific and/or clinical research, is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation including clinical study reports, protocols as well as investigator brochures and manuscripts across various therapeutic areas.  Many of the reports produced by our Medical Writing team have been submitted to USFDA and EMEA.

Overview – Clinical Data Management & Medical Writing

• Supporting 90 clients based in USA, Europe, Israel, India…
• ISO 27001:2005 certified for Information Security Management System
• 21 CFR Part 11, compliant system for eCRF and paper CRF data entry
• Site training and 24 hours help desk services available
• The latest software is used to improve the accuracy and integrity of the clinical data:
  • SAS suite PheedIt v 3.03 for CDMS
  • SAS Analytics v 9.1.3. for analysis
  • Latest versions of WHODD & MedDRA
• Our medical writing team works closely with leading KOLs across the country -  in order to access a fully-integrated network of information
• Applicable regulatory & commercial guidelines:
  • Protocol: ICH-E6, Schedule Y
  • CSR: ICH-E3, Schedule Y
  • Publications: GPP-2

About Max Neeman International
Max Neeman International is a leading Indian CRO with global capabilities. Our specialty is that we offer services for the successful conduct of Phase I-IV clinical drug and device trials for small and mid-sized Pharmaceutical, Biotech, 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 active in 31 cities with 6 regional offices.  For more information please contact Donald Swankie, Vice President of Business Development:  [email protected] / 919.424.3345 or go to www.neeman-medical.com.

SOURCE Max Neeman International