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European CRO and US-based Trial Management Organization Announce Unique
Partnership to Ensure Highest Quality of Clinical Trials in India
June 17th 2009 Zürich/Chicago– In response to growing demand by
European and US biopharmaceutical companies for clinical trial support services
in India from established and proven providers, Excel Life Sciences (ELS), a
US-based India-focused clinical trial management organization and PFC Pharma
Focus (PFC), a Switzerland-based pan-European contract research provider,
announce the launch of PFC India, a full-service contract research organization
specializing in clinical monitoring and data management services.
The exclusive relationship between ELS and PFC to launch PFC India combines the
strengths of a long standing and successful European CRO in PFC with the local
expertise, ground-based business savvy and quality focused trial management
organization servicing global clients in ELS.
PFC India is established as a division of PFC and is a distinct entity from ELS
and will service biopharmaceutical companies and CROs with their clinical trial
support needs in India. The office will be located in New Delhi. Specifically,
PFC India will offer its clients study planning, monitoring, audit and data
management services.
“I am very pleased that we can extend our clinical research services with PFC
India from Europe to Israel to India and to offer our clients access to a large
diverse patient population as well as to a significant number of patients
suffering from rare diseases" said Dr. Kurt Pfister, CEO and co-founder of PFC
Pharma Focus Ltd. in Switzerland. India offers the unique opportunity of highly
trained medically qualified persons and a legal and regulatory environment fully
supporting international GCP standards. ELS is well established in India and the
team has market leading experience in conducting global trials. They have a
proven track record in involving high performing centers with very good patient
recruitment and retention rates and will enable us to make a smooth entry into
this geographical area. “Selection of ELS as a partner was a result of rigorous
due diligence and a shared vision to conduct clinical research with the highest
levels of credibility, ethics and integrity” said Dr. Pfister.
“We are excited about this unique new relationship, brining one of the most
respected European-based CROs to India. PFC India will bring an unprecedented
focus on quality data and good clinical practice to India, at a time when the
FDA and Drugs Controller General’s office of India is stepping up it’s
compliance standards and pharmaceutical companies are requesting a high level of
service, preferably from an experienced and established brand” said Dr. Vijai
Kumar, President and Chief Medical Officer of Excel Life Sciences.
The number of new clinical trials initiated in India is currently growing at
more than 50% annually, a growth rate that is requiring a substantial amount of
participation from India’s strong physician base and medical institutions in the
form of new clinical investigators and research sites. In addition, the number
of patients participating in trials in India is growing as well. Combined, these
market changes make it essential that all studies are monitored and managed at
or above the highest international standards to ensure quality, timeliness and
safety.
About Pharma Focus
Based in Switzerland, PFC Pharma Focus is a premium contract research
organization (CRO), providing product development services in the life science
and health care industries. Founded in 1992 by prominent experts in all realms
of clinical services, the mission of PFC Pharma Focus is to bring a new look to
the drug development experience by addressing the limitations of conventional
study practices. This year marks PFC 17 anniversary providing clinical services,
and our clients and partners include pharmaceutical, biotechnology, medical
device, and academic and government organizations. PFC services include running
clinical studies from phase I to IV+, medical writing, importing through storage
to distribution of clinical material, training in pharmaceutical medicine and
development of risk management plans. For more information visit:
http://www.pfc-cro.com/pages/index.cfm
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington
DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one
of the most experienced and fastest growing trial management and site support
organizations in India, offering customized clinical trial solutions including:
regulatory consulting, preparations, submissions and query resolution; site
identification and selection; patient recruitment and retention; training of all
clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in
India with over 125 years of collective experience in conducting more than 350
global and domestic trials at hundreds of sites and with thousands of patients.
ELS has also trained over 1,500 clinical research personnel in India. For more
information visit:
www.excellifesciences.com
Contact: Kurt Pfister
PFC Pharma Focus Ltd.
Zürich, Switzerland
Phone : +41 44 908 66 66
Kurt.pfister@pfc-cro.com
www.pfc-cro.com
Contact: Mohit Mehrotra
Excel Life Sciences
Chicago, IL
Phone: 773 251 2976
Mohit@ExcelLifeSciences.com
www.ExcelLifeSciences.com
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