Max Neeman International's COO, Dr. Renu Razdan published in BioSpectrum Citing Changes in India Clinical Research and Regulatory Environment
RESEARCH TRIANGLE PARK, N.C., July 30, 2013 /PRNewswire/ -- Max Neeman's COO, Dr. Renu Razdan published in BioSpectrum [July 2013]; a prominent industry magazine. As Max Neeman is the leading, local Indian CRO with most regulatory approvals, Dr. Razdan has firsthand knowledge regarding India's clinical research and regulatory environment and insights are shared in the article. Per Dr. Razdan, 'Focus on patient safety and ethical conduct of clinical studies can only increase Sponsor's comfort knowing study results are acceptable by all global regulatory bodies'. Given the high patient load in S.E. Asia, rapid enrollment outpaces slight increase of average approval time, in gaining regulatory approval.
USFDA, with oversight offices in India, has inspected numerous Indian sites with no serious non-compliance issues flagged. And, while the vast majority of clinical trials are conducted in compliance with national and global scientific and ethical standards, DCGI [Drug Controller General of India] has improved upon QA/QC measures with inspection and audit of all research facilities.
India with its large population of diverse ethnicities, modern infrastructure, and trained manpower has been a lucrative choice for pharmaceutical companies since 1988, when Schedule Y of the Drugs and Cosmetic Act became effective. India trial data has been accepted by USFDA and European Medicines Agency [EMA]. Recent schedule Y revisions, along with ethical and scientific guidelines, Good Clinical Practice [GCP] and ICMR ethical guidelines continue to improve the Regulatory environment which is in line with the International Regulations and International Conference on Harmonization GCP guidelines.
All the factors that established India as a strategic venue for clinical research are still intact and the Indian government is committed to guidelines that will benefit the 1.3B population and Sponsor alike. Please go to www.neeman-medical.com for the entire article and contact donald.swankie@neeman-medical with any questions.
About Max Neeman International
'Max Neeman' is a leading Asia-Pacific CRO with India expertise and expanded capabilities into N. America and Europe. Since 2001, the company has provided clinical research services for the successful conduct of drug and device trials in compliance with ICH GCP standards. The company is ISO 9001:2008 certified for monitoring, site management and data management with over >400 employees, 245 active sites in various therapeutic areas and 310 trials awarded. Data Management services alone have touched 60 countries. For more information contact Donald Swankie, Vice President USA: firstname.lastname@example.org or go to www.neeman-medical.com.
SOURCE Max Neeman International