For Immediate Release
Contact: Ronny Schnel
310-377-7517
rkschnel@criteriuminc.com
November 18, 2005
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.
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.
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 <a href="connect.php">IVR</a>
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 <a href="connect.php">IVR</a>
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
