Criterium Press Releases
for Immediate Release
Contact: Arthur Gonick
(518) 583-0095 x 117
aigonick@criteriuminc.com
Mumbai Investigative Meeting Conducted by Criterium,
Inc. Launches Clinical
Study Project in India for Thrombosis Research Institute.
(May 1, 2008- Saratoga Springs,
NY) – A meeting at The Mumbai Hyatt Hotel hosted
by Criterium Inc. and The Thrombosis Research Institute
(TRI) of London, England assembled over 60 investigators
from India, and marked the kick-off for a 2-year Phase
IIIB oncology study. This one day meeting prepared investigators
to conduct this major study of the incidence of symptomatic
venous thrombo-embolism (SVTE) events in patients being
treated for gastric cancer. Criterium India, Criterium
Corporate Management, and TRI management presented their
expectations to the investigators, further solidifying
the Criterium-Thrombosis Research Institute site team.
In this study Criterium is providing
Indian regulatory expertise, recruiting sites that will
screen, enroll, register and randomize 740 patients
at investigational sites representing every region in
India, monitoring the study, designing and validating
the case report forms, managing and analyzing the data,
and writing the final clinical study report.
Criterium’s New York headquarters
will coordinate real-time receipt and management of
the study data using StudyControl™, Criterium’s
innovative proprietary technology that integrates multiple
technologies with Criterium’s unique workflow
for seamless and timely reporting of results. Enrollment,
randomization, safety and efficacy information will
be available to the Criterium-Thrombosis Research Institute
team members in real-time as the data are received from
the sites immediately after each patient visit.
“The meeting was a rousing success;
the sponsor was extremely happy with the turnout and
the quality of the presentations” noted Eduardo
F. Jahn, Associate Director for Operations for Criterium
and Project Manager for this study, “This is a
tribute to the entire staff of Criterium India which
took the lead on all the many details involved in this
investigator meeting and provided an environment in
which investigators could sharpen their understanding
of this landmark study of SVTE events in patients undergoing
treatment for gastric cancer. Our team at Criterium
India made my job easy.”
StudyControl in combination with
on-the-ground Criterium staff in India allow headquarters
staff in Saratoga Springs, New York to manage the study
remotely.
Dr. Janice Manisha Maganji, Clinical
Trials Manager for The Thrombosis Research Institute,
commented: "It is very difficult for me to trust
somebody or delegate a job that I envision to be done
with a certain quality of perfection with correct, timely
flow of events. It takes time for me to be confident
and tell myself, 'my study is in safe hands'. With Criterium,
my confidence has gone from strength to strength.
Now I tell myself and my colleagues:
'Our trial is in safe, efficient and reliable hands'.
I can’t wait to initiate another and bigger project
with them.”
About Thrombosis Research
Institute: The Thrombosis Research Institute
is a multidisciplinary organization concerned with the
interrelated problems of thrombosis and atherosclerosis.
The mission of the Institute, set
out at its inception in 1990 and reiterated in 1997
is: To be the leading national multi-disciplinary organization,
providing excellence in thrombosis research, education
and patient care by seeking deeper understanding of
the molecular pathogenesis of disorders of coagulation,
in order to develop new strategies to prevent and treat
thrombosis.
The Institute’s activities
encompass drug discovery, basic scientific and clinical
research with the aims of understanding the disease
process, developing novel and affordable therapies whilst
identifying those most at risk at an early age so as
to intervene to prevent long-term disablement and early
death. For more information, see: www.tri-london.ac.uk
About Criterium
Criterium Inc., is a full service, global and technology
driven contract research organization that offers a
unique mix of high-quality, innovative clinical research
solutions for the biopharmaceutical, and pharmaceutical,
medical device and CRO industries. From thought to finish,
Criterium provides timely and accurate clinical trial
data and support services at every phase of development
allowing customers to make sound and cost effective
decisions about their clinical trials. Drug development
companies can benefit from Criterium’s expertise,
high-value services and products and high-end results.
Founded in 1991, Criterium’s services are customized
to fit each client’s specific needs, providing
a seamless flow of data and information from the investigative
site through Criterium back to the sponsor. To learn
more about the Criterium Edge, visit the website. Criterium
has corporate headquarters in Saratoga Springs, New
York with offices in Florida, California, South Africa,
India, Netherlands, Israel, Russia and Canada.
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