For Immediate Release
Contact: Ronny Schnel
310-377-7517
rkschnel@criteriuminc.com
October 7, 2005
Criterium participants from the United States, South Africa, India, and The Netherlands met for a week of intense cross-training workshops.
(SARATOGA SPRINGS, NY, October 7, 2005)
– Criterium, Inc., a global technology-based
contract research organization with in-depth
experience in providing clinical-research solutions,
has just completed their annual meeting.
Staff members from Criterium’s three offices, consultants,
and strategic partners gathered at the company’s headquarters
in Saratoga Springs for a weeklong meeting of workshops, presentations,
and team building exercises. Criterium’s annual meeting is conducted
to standardize procedures, enhance cross-cultural communication, and
re-evaluate the company’s strategic plan. “All of Criterium
staff, alliance partners and consultants made this meeting an unmitigated
success. A meeting of this nature was necessary as we position ourselves
for additional multi-national expansion,” says President and
Founder, John Hudak.
Since opening the office in South Africa two years ago, Criterium
has made it a point to ensure that there is a strong sense of team
unity and that the core philosophies of the company are practiced
in each office. Criterium typically has multi-national project teams
working closely together throughout the length of a project. “We
have been successful in the past due to our integration of user-friendly
technology, dedicated teams, and excellent communication. Having the
opportunity to spend a week together improves communication and allows
us to streamline our processes even more. It’s priceless,”
states Mary Stefanzick, Manager of Operations.
The entire staff participated in the Applied Good Clinical Practice GCP training conducted by Lawrence Reiter, Managing Director of Criterium Clinical Research (PTY) Ltd. in South Africa. Mr. Reiter is also the director of Applied Good Clinical Practice, which is a registered non-profit organization in South Africa that offers a variety of clinical research training courses. After attending the course each participant must pass a test to receive a certificate of competency. Criterium requires that all staff members maintain up-to-date knowledge of ICH GCP standards.
Dr. Gavin Leong conducted educational seminars on Anti-Infectives and HIV/AIDS. As a member of the staff in South Africa, Dr. Leong is a CRA and Medical Monitor. He periodically presents to the staff to ensure that everyone is educated about the implications and latest developments in the therapeutic areas that Criterium works.
In reflection of the meeting Ronny Schnel, Executive Director of Business Development and Client Services said, “This week was an opportunity for all of us to re-evaluate ourselves and our processes. It was a huge success, our capabilities are outstanding, and the possibilities are endless. Now more than ever, I encourage everyone to Get to Know Us!”
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
