Navigation Links
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: / 919.424.3345 or go to

SOURCE Max Neeman International
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Dr. Michael Yaremchuk, Leading Performer of Custom-Designed Facial Implants, Pioneers Bespoke Plastic Surgery
2. Dyadic Demonstrates Industry-leading Biofuels Enzyme Performance
3. Tanke BioSciences To Host Leading Symposium On Food Safety, June 24-25
4. Biodetection 2012 Conference Brings Together Leading Organizations from Around the World to Address Challenges & Technology Advances in Detection and Identification of Biological Threats in Washington, DC from June 28-29, 2012
5. TAKE Solutions Brings Together Leading Experts and TAKE Customers at “Converge 2012” to Discuss Business
6. UK supplier of graphenes announces exclusive sales agency agreement with leading USA distributor
7. Leading Technology Incubator Honors Extraordinary Entrepreneurs
8. Regulus Receives Allowance from Japan and U.S. Patent Offices for HCV Intellectual Property, Expanding Leading Worldwide Patent Estate
9. Leading Scientists to Debate Views on Rejuvenation Biotechnologies
10. Intellect Neurosciences Enters Collaboration Agreement with Leading Alzheimers Research Group at University of California Irvine to Test First in Class Dual Target Vaccine
11. Urologists Debunk Misleading, Grossly Inaccurate Prostate Cancer Biopsy Study
Post Your Comments:
(Date:11/25/2015)... , November 25, 2015 2 nouvelles ... fois les différences entre les souches bactériennes retrouvées ... des êtres humains . Ces recherches  ouvrent ... envisager la prise en charge efficace de l,un ... chez les chats .    --> 2 ...
(Date:11/25/2015)... 2015  Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) ... CEO of Neurocrine Biosciences, will be presenting at the ... New York . .   ... 5 minutes prior to the presentation to download or ... will be available on the website approximately one hour ...
(Date:11/25/2015)... Nov. 25, 2015 Orexigen® Therapeutics, Inc. (Nasdaq: ... in a fireside chat discussion at the Piper Jaffray ... . The discussion is scheduled for Wednesday, December ... .  A replay will be available for 14 ... , Julie NormartVP, Corporate Communications and Business Development ...
(Date:11/24/2015)... 24, 2015  Asia-Pacific (APAC) holds the third-largest ... market. The trend of outsourcing to low-cost locations ... higher volume share for the region in the ... margins in the CRO industry will improve. ... ( ), finds that the market earned ...
Breaking Biology Technology:
(Date:11/10/2015)... Nov. 10, 2015  In this report, ... basis of product, type, application, disease indication, ... this report are consumables, services, software. The ... safety biomarkers, efficacy biomarkers, and validation biomarkers. ... are diagnostics development, drug discovery and development, ...
(Date:11/9/2015)... , Nov. 09, 2015 ... the addition of the "Global Law ... their offering. --> ) ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) has ...
(Date:11/4/2015)... , November 4, 2015 ... new market report published by Transparency Market Research "Home Security ... Trends and Forecast 2015 - 2022", the global home security ... 30.3 bn by 2022. The market is estimated to ... period from 2015 to 2022. Rising security needs among ...
Breaking Biology News(10 mins):