For Immediate Release
Contact: Ronny Schnel
310-377-7517
rkschnel@criteriuminc.com
Other Criterium employees to be cross-trained on MedDRA Coding.
(SARATOGA SPRINGS, NY)- Criterium Inc., announces that Ms. Sheila Apger, Clinical Data Liaison, has completed a 2-course seminar on MedDRA coding, which is the current standard for symptom classification, and is highly preferred by the US Food and Drug Administration (FDA) for use in pharmaceutical trials and treatment protocols. The seminar took place in Boston, MA on May 20 & 21, 2003, and the courses involved are called
“MedDRA Essentials”, and “Coding with MedDRA”. MedDRA (“Medical Dictionary for Regulatory Activities”) technology is a clinically validated international classification system of symptoms and procedures that is used through the entire regulatory process, from premarketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. It begins with a basic level of 26 system organ classes, and works its way through 4 levels to the most specific and precise LLT’s or Lowest Level Terms. Currently there are over 58,000 Lowest Level Terms in the MedDRA recognized database. The goal of MedDRA is to provide international multi-lingual standardized communication between all regulators and the pharmaceutical industry. Like other dictionaries, this is a dynamic database, and MedDRA will be adding new Terms as needed twice a year.
“This investment in our personnel and their skills and abilities is as always a concurrent investment in our clients”, observed Criterium, Inc. President John M. Hudak, “Our clients can feel confident that when they choose to utilize our services, they will be receiving the most complete and up-to-date procedures and methods.”
In the near future, Ms. Apger will be cross-training other Criterium personnel to enable more clients to choose to utilize MedDRA coding for their clinical trials.
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 expertis e, 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 Criterium, visit www.criteriuminc.com or call (518) 583-0095.
