Criterium Press Releases
For Immediate Release
Contact: Ronny Schnel
310-377-7517
rkschnel@criteriuminc.com
November 18, 2005
Criterium, Inc. Opens New Office
in India
New data management center enables
Criterium to handle large quantities of data while maintaining
“real-time” philosophy.
(SARATOGA SPRINGS, NY, November 17,
2005) – Criterium, Inc., a global technology-based
contract research organization
with in-depth experience in providing clinical-research
solutions, announced today that they have opened
an office in Pune, India
after working there for the past two years.
Gautam Jit Kanwar has been named the director of Criterium
India. Mr. Kanwar has over ten years of experience in
developing data processing solutions and managing offshore
teams. The office employs an experienced data processing
and quality assurance staff. With a dedicated team assigned
to each project, and experienced project leaders, Criterium
ensures the best quality data and the most efficient
use of time.
India is increasingly known as a major
player in software and IT talent throughout the world.
India also has the largest number of FDA approved manufacturing
facilities outside of the United States. With the annual
growth of industry increasing rapidly, President and
Founder of Criterium, Inc, John
Hudak is confident that this expansion will promote
positive growth for Criterium to ensure that clients
are continuously receiving first-rate service. “Criterium
India is comprised of top quality personnel and world-class
systems. Working in a region before opening an office
constitutes the next step in the implementation of Criterium's
strategy to flatten our process of providing world-class
clinical development services. No matter where a staff
member sits, he or she is integrated into our processes
using technology developed within the company.”
The project team in India
works directly with the teams in South Africa and the
United States. This multi-national approach to conducting
a clinical trial has
been an outstanding success for Criterium. With the
proper use of technology and unified personnel, the
data flow as well as the communication is seamless.
The time difference between Criterium’s four offices
enables the team to provide 24-hour coverage on all
projects.
About Criterium, Inc.:
With headquarters in Saratoga
Springs, N.Y., and offices in Rolling
Hills Estates, Calif., and Johannesburg,
South Africa, Criterium is a global technology-based
contract research organization
that offers a unique mix of high-quality, innovative
clinical-research solutions
and communications tools to manage the entire clinical-research
process from initial planning to approval. The biopharmaceutical,
pharmaceutical, medical-device, and CRO industries 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.
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Criterium was established with the
belief that with streamlined processes and state of
the art technology, any project will result with the
same outcome - “Done right and on time!”
Over the last decade this idea has proven itself true.
Due to repeat business and a knowledgeable staff, Criterium
has developed specific therapeutic expertise.
Allergy:
Criterium has worked with several
Intra-Nasal products, oral medication, steroids, and
anti-histamines for phase II-IV clinical, and therapeutic
bio-equivalence studies. Studies have been conducted
in the United States and South Africa. An understanding
of the allergy seasons in both hemispheres has been
beneficial for meeting strict timelines For these studies
Criterium provides centralized monitoring and remote
study management using paper-based, Automated Fax, and
collects pivotal data from TeleDiary, our trademarked
IVR System for collecting data directly from patients.
Respiratory:
Criterium has experience with metered-dose
medicinal aerosols to deliver a variety of drugs directly
to the lung. These drugs include beta-agonists and steroids
for asthma as well as oral and injectable drugs for
pulmonary fibrosis, cystic fibrosis, and respiratory
tract infections.
Women’s Studies:
Criterium’s technology is ideally
adapted for conducting large studies in women’s
health in Phase III and Phase IV and using our technology
tools, we have contributed pivotal data to NDAs, Supplemental
NDAs and ANDAs. The areas in which Criterium has experience
are:
Premature Labor and Delivery, Oral
contraception, Hormone Replacement Therapy, Bleeding
Disorders, Urinary Incontinence, Bacterial Vaginosis,
Vaginal Infection
Pain Management:
Criterium senior management has years
of experience designing, conducting, managing and summarizing
studies of agents administered for acute and chronic
pain including arthritis, surgical pain and cancer pain.
Using our TeleDiary IVR services, we collect data directly
from patients who evaluate their absolute pain, changes
in pain and pain relief when treat treated with narcotic
or non-narcotic analgesics, administered orally, by
injection or transdermally. We have provided data gathered
in this way for NDAs and Supplemental NDAs. Areas in
which Criterium has expertise include:
Narcotic, Non-narcotic, Acute and
Chronic Pain, Malignant an Non-Malignant Pain, Headache
pain, Migraine, Trancutaneous nerve stimulation
HIV/ Infectious Disease:
Criterium has worked in various capacities
to conduct studies in patients with Infectious Diseases.
Our office in South Africa is a platform for conducting
HIV studies in sub-Saharan Africa. Our South Africa
staff is experienced in the management of vaccine and
therapeutic studies. Difficult-to-find populations are
usually more readily available for study in South Africa.
Criterium also provides pharmacy management services
as well as clinical monitoring, remote study management
and data management and analysis services in the following
areas:
LRTI, Pediatric Pneumonia, Chronic
Bronchitis, Skin and Soft Structure Infection, UTI,
HIV, Bacterial Vaginosis, Fungal Infections
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