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Leading India-USA based CRO Announces Data Management/EDC, Medical Writing Milestone
Date:7/23/2012

s 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
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