Real-time data. Real-time reports. Real-time results in clinical research.
We develop and implement effective and efficient Interactive Response Technology solutions that are customized for each client and every study.
Our goal is to provide contract research organizations, pharmaceutical, biotechnology, and medical device companies with global applications that put key decision-making information at their fingertips.
How we’re different:
- We’re ePRO experts. We develop and customize telephone scripts and electronic patient diaries (ePRO or electronic Patient Reported Outcomes).
- We keep it simple with seamless integration. We’re dedicated to developing Interactive Response Technology systems that interface seamlessly with other technologies (such as EDC) to provide data collection and comprehensive management of each clinical study, including Adaptive Trials.
- We’re agile. IVRCC provides a fast and effective solution to gather and report data for clinical development firms of all sizes.
- We’re global. Our ePRO solutions have global reach and capability.
Our Leadership Team
John Hudak, MBA
President and Founder
John Hudak, MBA
President and Founder
John Hudak, President and Founder of IVR Clinical Concepts Inc., has more than 40 years of experience in the pharmaceutical research and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning, proposal design, custom-services development, international project management, and clinical study completion. He’s also an expert in protocol design and implementation, tracking, and electronic data capture. 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.
Kathleen Wanser
Director, Technology Platform
Kathleen Wanser
Director, Technology Platform
Ms. Wanser directs the “technical backdrop” of the supporting servers and telephony lines to maintain flawless up-time performance and continuous daily functioning of the nuts and bolts hardware of our systems. She directs the high security and compliance of systems throughout, paying particular attention to uninterrupted performance, system robustness, regulatory compliance and intense daily monitoring of the systems.
Gregory J. Bailey
Senior Programming Manager
Gregory J. Bailey
Senior Programming Manager
Greg Bailey is responsible for providing quality technology solutions to meet the needs of our clients. He uses his extensive background working 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 IVR and IWR applications, with particular skills in e-clinical integration applications.
Mr. Bailey specializes in developing programming solutions. His own company has developed FDA audited database interrogation software for contract research organizations, corporate relations management software for universities, time management and membership tracking applications for several organizations. He has previously worked as a senior programmer for Mathew Bender and Associates, Glens Falls Hospital, Fleet Financial, and Digital Equipment Corporation.
Nancy Hudak
Business Development Account Manager
Nancy Hudak
Business Development Account Manager
Nancy Hudak came to the clinical study technology industry through her passion for all things “science”, and a desire to provide solutions to make people’s live easier. After earning Biology and Psychology degrees from Williams College, she joined a small business in the metalworking lubricants industry where she advanced from entry-level chemical technician to Director of the regional lab.
In 2008, Nancy relocated to Saratoga Springs to further her career in the world of clinical studies, first taking a role helping a long-established CRO’s Business Development Team, and eventually shifting to their sister company, IVRCC. In her current role, Nancy specializes in helping clients apply custom technology solutions for improved data collection with IVRCC’s continually advancing voice, web and mobile digital technologies. She also helps coordinate budgeting and contracting, project management, technical training, business development and marketing.
Our Partners
IVR Concepts
IVR Concepts is a premier vendor of world-class Interactive Voice Response (IVR) hosted telecom solutions and Interactive Web Response (IWR) applications. Our technology platforms are capable of hosting a multitude of simultaneous applications, any of which can utilize our standard functions, including Prompt Playback, DTMT Digit Capture, Voice Sample Recording, Incoming Call Redirects, Call Blocking, Voice Transcription, Audio Call logging, Credit Card Processing, Custom Database Integration and Extranet Web Site Integration.
Our state of the art facility has all the resources needed to provide impeccable IVR services, both in- and out-bound. These resources include redundant hardware and software, long distance carrier connectivity and text to speech functions. We offer hosted service bureau solutions based on the latest carrier grade, field proven Voxpilot VoiceXML automated speech recognition (ASR) platforms, text to speech (TTS) as well as low-cost , highly efficient touch-tone (DTMF) technologies.
IVR Concepts is a leading provider of hosted IVR and IWR solutions and services that facilitate cost savings and increased efficiency. Our design and customer care teams work closely with our clients to develop applications that automate a wide variety of tasks, eliminating the drawbacks associated with paper data collection methods. and help to avoid non-compliance issues. Our innovative solutions, from reminder, alert and notification messages to the most complex clinical trial processes, can help keep your project on time, prevent budget overruns and ensure protocol compliance.
By providing exceptional customer service, quality and value in our hosted and managed IVR and IWR services, IVR Concepts has earned the trust, confidence and loyalty of clients both domestic and international. We offer organizations of all types and sizes outstanding personal service, platform reliability, advanced technology, industry compliance, large capacity and cost savings.
Criterium Inc.
Criterium Inc. is a full service, global and technology driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, and pharmaceutical, medical device and CRO industries. From thought to finish, Criterium provides timely and accurate clinical trial data and support services at every phase of development allowing customers to make sound and cost effective decisions about their clinical trials. Drug development companies can 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. To learn more about the Criterium Edge, visit the website. Criterium has corporate headquarters in Saratoga Springs, New York with offices in Florida, California, South Africa, India, Netherlands, Israel, Russia and Canada.
Caligor Coghlan Pharma Services
The capabilities of Caligor Coghlan Pharma Services include clinical commercial drug sourcing, clinical packaging, labeling, worldwide distribution, logistics, storage, and destruction as well as various consulting services.
Biomedical Statistical Consulting
Biomedical Statistical Consulting is a contract research organization specializing in the design, implementation, and presentation of clinical trials and other medical research studies since 1986. BSC generates randomization algorithms for clinical trials using block, stratified randomization, and covariate adaptive techniques to support management of balancing sample sizes and controlling the influence of covariates a priori. They have extensive experience in a wide variety of therapeutic area clinical trials conducted to support the regulatory process including 510(k), PMA, and post approval studies. They employ a wide range of statistical tools to studies including frequentist and Bayesian study designs, adaptive study designs, and propensity score methods. An additional benefit is excellent ability to collaborate with Sponsors and their scientific consultants in the design of studies, including hypothesis and outcome measure development; statistical power and sample size analysis; and in the interpretation and presentation of statistical analysis results.
BSC is expert at providing representation for Sponsors at FDA meetings including pre IDE and Panel meetings. They also have substantial experience in ANDA studies for clinical bioequivalence and in scientific research and development including modern classification and prediction technology. The Principal Biostatistician has co-authored over 160 publications in peer-reviewed medical research journals, and is also Adjunct Associate Professor of Statistics in the Medical School of the University of Pennsylvania. BSC staff includes experienced Associate Biostatisticians, Statistical Analysts, Statistical Programmers, and Data Base Managers. Visit their website and see their interactive consulting resume for more information, including lists of past and current clients, experiences, and areas of expertise.
Our Clients
