India's Draft on Clinical Trials Aims for Speedier Drug Approvals
Feb 2018
Mr. Partha Chatterjee, Head, Clinical operations and Clinical Trial Supplies, SIRO Clinpharm provides his insight on how India's draft clinical
trial rules would reduce the time it takes to approve clinical trials, and make the process more transparent.
Reproduced with permission from Pharmaceutical Law & Industry Report, 16 PLIR (February 23, 2018). Copyright 2018 by The Bureau of National
Affairs, Inc. (800-372-1033) www.bna.com
Synergy between Clinical Operations and Clinical Trial Supplies for Optimum Trial Execution
May 2017
A worth-while read, this article by Partha Chatterjee, Swapna Keshav and Sujay Salvi details the need for the clinical operations and clinical trial supply teams to come together to form one cohesive excellence unit with an unbroken chain of command and line of sight.
Pharmaceutical Manufacturing and Packing Sourcer (PMPS), May 2017 - View Details
Maximising the efficiency of Clinical Trial Supply Chain
March 2017
In an insightful article Partha Chatterjee and Sujay Salvi detail how maximising the efficiency of clinical trial supply chain can provide a competitive advantage.
Wearable devices – Future of healthcare; steps towards better life
September 2016
Namrata Belekar writes a comprehensive article on wearable medical devices highlighting some of the most commonly used ones, their claim studies and FDA recommendations to overcome any possible harm from wrong use.
Dr. Vatsal Shah, Chief Operating Officer, in his interaction with Usha Sharma talks about the company's ambitious plans and some of the challenging tasks which he has undertaken to maintain the company's growth trajectory.
Biotecnika magazine, an India-based magazine focused on biotechnology industry had an opportunity to interact with SIRO Clinpharm's operational heads in tete-a-tete interview for their November 2014 issue.
Dr. Vatsal Shah from SIRO Clinpharm takes a session at the prestigious PHARMATECH conference
Dr. Vatsal Shah, global head, medical writing and pharmacovigilance, SIRO Clinpharm, was on the expert panel on the recently
concluded PHARMATECH-2013.PHARMATECH is a one-of-its-kind bi-annual national conference and workshop on clinical research for
postgraduate students and researchers, organized by the Department of Pharmacology & Therapeutics of the prestigious Seth GSMC &
KEM Hospital in Mumbai.
Finding Alignment: Opportunities and Obstacles in the Pharma/CRO Relationship
A report from the Economist Intelligence Unit 2012
The report draws on a survey of 251 senior executives from the life sciences industry as well as in-depth interviews with
corporate leaders and industry experts, where Dr. Ajit Nair, President, Global Clinical Operations, SIRO Clinpharm, shares the
platform renowned industry experts.
REG - Xenetic Biosciences - Phase I/IIa IV trial for ErepoXen®
February 13, 2012
Xenetic Biosciences plc (LSE: XEN.L), a bio-pharmaceutical company specialising in the development of high-value differentiated
biological and vaccines and novel cancer drugs, announces that, in a Phase I/IIa IV (intra venous) clinical trial, its
co-development partner, the Serum Institute of India ("SIIL"), has dosed its first patient with their jointly-owned ErepoXen®
candidate.
Manuscript vs Regulatory Writing: The Key Differentiators
DIA 6th Annual Magazine, India 2011
Dr. Nimita Limaye - Senior VP & Global Head: CDM, Medical Writing & SCEDAM Dr. Lakshmi Venkatraman - PhD, Senior Manager, Publications and Safety Dr. Wendy Battisti - PhD., Director, Regulatory Medical Writing, Johnson & Johnson Pharmaceutical Research & Development Dr. Susan Glasser – PhD., Senior Director, Regulatory Medical Writing, Johnson & Johnson Pharmaceutical Research & Development
Enabling Success Factors to a Functional Outsourcing India-based Partnership in Statistical Programming
6th Annual Conference on Global Drug Development and Market Access
Dr. Nimita Limaye - Senior VP & Global Head: CDM, Medical Writing, & SCEDAM Mr. Frederic Coppin - Manager, ex-US operations and sourcing partnerships, Global Scientific Programming, MSD
SIRO Clinpharm wins 'Indian Clinical Research Organisation of the Year' award
September 23, 2011
Dr. Ajit Nair, President, Global Operations, accepts the award on behalf of SIRO Clinpharm, "This award has indeed recognized our efforts in the clinical research sector. As a company we have always strived for excellence in providing clinical research services to our clients. It is a pleasure to receive this prestigious award again after 2007 and I am sure SIRO's performance in the healthcare sector will bring in more such appreciations for the organization."
ET NOW
SIRO Clinpharm receives Indian CRO of the year award
September 30, 2011
SIRO Clinpharm has been conferred with the Indian clinical research organization of the year 2011 award by Frost & Sullivan. The award was presented in Mumbai by Dr. Ajaykumar Sharma, pharmaceutical practice head, Frost & Sullivan, Middle East & India.
SIRO Clinpharm takes initiative in medical writing training
SIRO Clinpharm a leading Contract Research Organisation (CRO) based out of India and Western and Central Eastern Europe recently announced its plans to launch CEMW (Centre of Excellence for Medical Writing), a first of its kind training institute in the field of medical writing in India.
SIRO Clinpharm announces launch of 'On Trak' – clinical trial management platform for its Indian
operations
Monday, 11th October 2010
SIRO Clinpharm, a leading Contract Research Organization (CRO) based out of India and Western and Central Eastern Europe, today announced launch of 'On Trak', its Clinical Trial Management System.
SIRO joins with DreamCIS to access Korean patient pool
Monday, 08th February 2010
SIRO Clinpharm has formed an alliance with South Korea-based CRO DreamCIS to expand its clinical trial offering in Asia Pacific and provide clients with more options for patient recruitment.
SCDM Board of Trustee Elections Strengthen Global Focus
Tuesday, October 20, 2009
Nimita Limaye, CCDM, was elected as vice chair for 2010. Limaye, vice president of CDM and medical writing at
SIRO Clinpharm in Mumbai, India, is the first non-North American to serve as an officer on the SCDM Board of
Trustees.
DBMS Consulting Successfully Completes Roll out of Oracle Health Sciences Applications (OHSA) Suite for
SIRO Clinpharm
Wednesday, October 7, 2009
DBMS Consulting announced that it has successfully completed deployment of Oracle Life Sciences
Applications (OHSA) Suite and Oracle E-Business Suite (EBS) for SIRO Clinpharm, one of the leading global CROs
headquartered in Thane, India. OHSA offers fully automated capabilities in management of clinical trial process,
clinical trial data and global adverse event reporting.
SIRO Clinpharm Selects Oracle's Life Sciences Applications
Wednesday, February 20, 2008
SIRO Clinpharm Private Limited (SIRO), a clinical research organisation (CRO), is going to implement
a new IT framework comprising Oracle's Life Sciences Applications (OLSA) and other Oracle applications running on
Sun Microsystems' hardware platform.
Siro Clinpharm offers clinical trials for Indian firms in overseas sites
The Mumbai-based Siro Clinpharm Pvt Ltd, one of the leading players in the Indian contract research
industry, is planning to offer clinical trials for Indian pharmaceutical companies in overseas sites such as the
US and Europe.
The Indian CRO sector registered 70 percent growth in 2006-07 over the previous year's revenues of Rs
425 crore with exports dominating the sector.Datamonitor's R&D Strategies 2007 report points out that the drug
developers have become increasingly dependent on CROs, which themselves have become increasingly globalized.