Image Solutions Inc., (ISI), a leader in providing software and service solutions to support the drug development lifecycle, announced today the appointment of Dennis Nazareno as ISI’s Director of Clinical Solutions. Nazareno brings nearly 20 years of industry experience and knowledge to ISI’s clinical solutions team and will spearhead the development of the company’s next-generation clinical solutions. He comes to ISI most recently from Organon, where he led the company’s global efforts to select, evaluate and implement various clinical trial management solutions.
The appointment represents ISI’s continued efforts to innovate in the clinical arena, enabling the company to provide integrated solutions that help companies manage processes across the clinical and regulatory domains. Recognizing that most pharmaceutical companies today employ both electronic and paper-based approaches to manage clinical trials, ISI has been aggressively enhancing its clinical solution suite to accommodate industry’s current business processes and the move to Electronic Data Capture (EDC).
“A 100 percent electronic approach to clinical trials is an industry aspiration but probably won’t be a reality for years – if ever,” said Nazareno. “Even the largest pharmaceutical companies with extensive IT resources have struggled to implement eClinical solutions. It’s clear that the benefits of automation face a considerable barrier in that, today, more than 90% of clinical trials still use paper as the medium to collect, communicate, and manage data. Recognizing the market’s desire for a simplified, pragmatic solution for clinical trials, ISI is developing a powerful ‘hybrid’ solution that is built on common paper/electronic processes and is fully integrated with EDC solutions, clinical data management systems, as well as document management systems.”
One of the most difficult aspects of data management in clinical trials is the management and global collaboration of patient information contained in thousands of case report forms. In addition to dedicating significant R&D resources to new product development, under Nazareno’s leadership ISI is enhancing its flagship clinical product, CRFTrack – an intelligent document imaging, management, tracking and reporting system used to manage Case Report Forms (CRFs) both during clinical trials and while preparing for electronic submissions.
In combination with product enhancements, ISI is strengthening its global outsourcing capability to accommodate the life sciences’ industry growing presence in emerging markets. Currently, many of the world’s largest pharmaceutical companies use ISI to process and archive CRFs for both clinical and regulatory use. The combination of CRFTrack, with outsourcing support from ISI around CRFs, significantly improves decision making and collaboration among key team members and ultimately streamlines clinical and regulatory processing.
Nazareno joins ISI after having successfully implemented CRFTrack at Organon’s Roseland facility. Nazareno held a number of positions at Organon since he began his career there in 2001, including application manager in Clinical Development Operations, project manager, business IT analyst, and technical lead for Organon’s Clinical Development unit. Paul Chung, ISI’s Senior Vice President of Software & Services Operations stated: “I am extremely optimistic to have Dennis join the ISI team, and I look forward to the added value he brings to the organization and the far reaching effects it will have for ISI’s continued growth as market leader within the clinical space.”
About Image Solutions, Inc. (ISI)
With operations in the US, Europe and Asia, Image Solutions, Inc. (imagesolutions.com) is a global, privately-held company founded in 1992 with an established reputation as the worldwide leader in providing comprehensive software and outsourcing solutions to clients in the Life Sciences, Government and other regulated industries. Today, ISI performs work for over 120 clients worldwide, including the top 50 Pharmaceutical and Biotech organizations worldwide.
Since 1992, ISI has pioneered innovative electronic submission and document management tools, earning an unprecedented reputation of delivering exacting quality, while improving their clients’ speed-to-market regulatory approval timeliness for new medicines.
ISI World Headquarters are located in Whippany, New Jersey, with west coast offices in San Francisco, California, and satellite offices throughout the United States. ISI International is headquartered in Frankfurt, Germany with additional offices in and Bristol, United Kingdom. ISI Research supports operations in Seoul, South Korea, and through a partnership with CAC Corporation, ISI also markets its products and services in Japan and the Pacific Rim countries.