RESEARCH TRIANGLE PARK, N.C., May 3, 2011 /PRNewswire/ -- The Drug Controller General of India (DCGI) has formed new Regulatory and ICH GCP guidelines. These guidelines include: recommendations regarding structure and format of genomic biomarker regulatory submissions; the Development Safety Update Report (DSUR), intended to be a common standard for periodic reporting on drugs under development among ICH regions.
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In response to the new guidelines, Max Neeman (leading Indian-based CRO) trained the Quality Assurance team and incorporated required changes into SOPs to carry out trials for biomarkers and stem cell trials. Extensive, timely, up-to-date training in response to India regulatory bodies provides for an exceptional level of knowledge regarding the most current Indian Clinical Trial Regulations, ICH GCP guidelines and ISO and ISMS standards.
Quality Assurance forms an integral part of drug development to maintain the integrity of clinical trials. Max Neeman continually trains employees to keep current with new DCGI, ICH GCP guidelines and to seek out the most effective actions to correct and prevent issues. Company QA auditors have years of hands-on experience working as CRCs and CRAs which allows for in-depth knowledge of operational aspects. Based on this and strong SOPs, the team can provide insightful recommendations, helping to ensure compliance and high quality results.
In addition to a comprehensive internal Quality Assurance program, Max Neeman provides stand alone service to sponsors and clients. A full range of clinical audit services exist from SOP preparation to advice on trial implementation in order to maintain the highest standard of conformance to ICH GCP regulations. Indeed, Max Neeman has successfully completed a 5th external regulatory audit for highest enrollment globally.
About Max Neeman International
Max Neeman International is one of the leading and largest CROs in India and the clinical research arm of healthcare conglomerate, Max 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 has 6 regional offices and 175 sites across 31 cities. Contact Donald Swankie, Vice President USA via email to donald.swankie@neeman-medical.com or call +1.919.424.3345. www.neeman-medical.com
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