Criterium provides Quality Solutions, reduces Costs, and accelerates Timelines. Our staff members are motivated to make sure each and every client is satisfied. When we exceed clients’ expectations for the entire clinical research process everybody wins.
John Hudak, MBA —
President and Founder (18 years)
jmhudak@criteriuminc.com
John Hudak, President and Founder of Criterium Inc., has more than 36 years of experience in the pharmaceutical research and business development arena serving the pharmaceutical and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning and tracking, proposal design and custom-services development, international project management and clinical study completion, protocol design and implementation, electronic data capture, and market communications. Recognizing the inefficiencies inherent in traditional clinical studies, Mr. Hudak has developed technology service solutions to reduce the time and cost required to manage clinical trials. A well-respected industry thought leader, Mr. Hudak is the author of numerous articles and white papers and speaks often at conferences and events.
Ronny Schnel — Executive
Director, Business Development and Client Services (12
years)
rkschnel@criteriuminc.com
Ronny Schnel is Director of Business Development and Client Services. Her background includes management of clinical investigative sites, implementation of innovative systems for the successful completion of clinical studies, compliance with good clinical practices, and the effective use of negotiation and mediation techniques to reduce project-related stress caused by organizational issues. Ms. Schnel manages client requirements through frequent contact and monitors progress of projects to ensure compliance with timelines and budget projections, Criterium’s standard operating procedures, and sponsor guidelines. Working with management teams. she assists in analyzing and recommending value-based strategic and financial alternatives that enhance a client’s ability to accomplish its mission and meet or exceed its financial goals. Ms. Schnel is the author of numerous articles and is a frequent speaker at industry events.
Mary Stefanzick — Director,
Data Operations (14 years)
mtstefanzick@criteriuminc.com
Mary Stefanzick has more than 14 years of experience in implementing and supporting interactive voice response systems and has been instrumental in developing Criterium’s proprietary Clinical Data Liaison approach to clinical trial management. In her current operations role, she assesses a project’s needs. She is responsible for hiring, managing, and training the staff and consultants required to complete the project. This includes full-time, part-time, and contract administrative, data management, and information technology staff. Ms. Stefanzick continues to improve processes while adapting new technologies to provide excellence in all trial management solutions. She also oversees software-testing activities and she has been instrumental in the development of quality systems and 21 CFR Part 11 compliance.
Lawrence Reiter, PhD — Director
of Global Affairs (6 years)
L_reiter@criteriuminc.com
Dr. Reiter has experience in both pharmaceutical and CRO organizations. His extensive global experience enables him to communicate and assist with a wide range of clients and clinical sites worldwide. In addition to South Africa, Dr. Reiter has managed clinical studies in the United States, Europe, Eastern Europe (including Russia), Australia, and other African nations. He has experience managing HIV/AIDS, sepsis, malaria, infectious disease (herpes, pneumonia), GI, oncology, cardiovascular, pulmonary, and allergic rhinitis studies. Dr. Reiter also is well-known in South Africa for his role in training sites and industry professionals in Good Clinical Practices. Dr Reiter is responsible for affairs outside of the United States by managing the establishment, development and operations of Criterium offices worldwide. In addition, Dr Reiter directs all Project Management activities, overseeing the monitoring, training management of studies and global sites.
Gregory J. Bailey — Director
of Programming (9 years)
gjbailey@criteriuminc.com
Greg Bailey is responsible for providing quality technology solutions to meet the needs of clients. He uses his extensive background in medical IT organizations as a platform to develop creative, secure, and quality applications. Mr. Bailey’s main role is to provide the continuing support and enhancement of StudyControl™ Criterium’s proprietary clinical trial data management application.
