Criterium's Executive Management

John Hudak- MBA -President and Founder
jmhudak@criteriuminc.com

Mr. Hudak, President and Founder of Criterium, Inc., has more than 30 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 conceived technology service solutions to reduce the time and cost required to manage clinical trials.

Ronny Schnel- Executive Director, Business Development and Client Services
rkschnel@criteriuminc.com

Ms. 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. She has worked as a consultant with an Asian-based CRO to develop international communications systems. Ms. Schnel holds a master's degree in negotiation and conflict management and she is responsible for identifying, evaluating, and assisting in the negotiations of all contracts. She assesses personnel and systems critical to delivering quality service to Criterium’s pharmaceutical, biotechnology, and medical-device clients. She manages client requirements through frequent contact, and monitors progress of projects to assure 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.

Mary Stefanzick- Associate Director, Operations
mtstefanzick@criteriuminc.com

Ms. Stefanzick has more than 10 years of experience in implementing and supporting Interactive Voice Response systems. In her current operations role, she assess a project's needs and hires, manages, and trains the staff and consultants required to complete the project. This includes full-time, part-time, and contract administrative, data management, and information technology staff located at the company’s headquarters in Saratoga Springs, NY. 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.

Eduardo Jahn- Associate Director, Operations

Mr. Jahn understands the diversity and cultural issues central to managing global clinical trials and is able to communicate these issues to our client partners. With more than 15 years of experience in international negotiations, Mr. Jahn brings a perceptive eye to the central issue of cultural awareness in the global pharmaceutical research industry. In addition, he has served as lead monitor for clinical studies in the United States as well as South America, England, Europe, South Africa, and Southeast Asia. In the office he is responsible for critical document image management, which includes regulatory documents, source documents, and patient CRFs.

Lawrence Reiter, PhD- Director, Global Affairs/ Managing Director, Criterium South Africa
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 in South Africa. 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.

Gregory J. Bailey- Director of Programming
gjbailey@criteriuminc.com

Mr. Bailey is responsible for providing quality IT solutions to meet the needs of our clients. His extensive background in medical IT organizations provides a platform to develop creative, secure, and quality applications. Mr. Bailey's main role is the continuing support and enhancement of StudyControl ™ Criterium's proprietary clinical trials data management application.