| Name | Title | Contact Details |
|---|---|---|
Shawna Felix |
Director, IT Integration - Optum Northwest | Profile |
Learn about the first and only holistic Regulatory Information Management (RIM) software for medical device companies that consolidates all the functions of regulatory affairs.
Roha Food Colors is a Trumbull, CT-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Imaging Endpoints (IE) is an imaging research and core laboratory that provides imaging CRO services to evaluate drug and device efficacy. We specialize in providing the industry`s leading radiology expertise and most advanced technologies through exquisite service. • LOCATIONS: Imaging Endpoints is based in Scottsdale, AZ, with offices in Waltham, MA, and Hyderabad, India as well as new offices opening soon in Basel, Switzerland; Amsterdam, the Netherlands and Shanghai, China. • AFFILIATES: We are an affiliate of HonorHealth, one of the largest healthcare systems nationally. We are also an affiliate of Scottsdale Medical Imaging, Ltd., part of the largest private radiology group in the US. • DEEP SCIENCE: Our Medical and Scientific Affairs Team includes world-class leaders in imaging science. Over 50 publications in leading journals have established us as a technology leader. IE`s experience spans hundreds of successful studies across all phases of development, including the most complex and high-profile Phase 3 trials in the industry. • EXPERT READERS: Our team includes over 100 physician readers comprised of 40 in-house radiologists and academically based expert radiologists, oncologists, surgeons and other physicians in the US. • GLOBAL SERVICES: We are one of the largest global imaging CROs in oncology. We receive/read scans in real-time from hundreds of imaging sites in over 35 countries. • SETTING NEW QUALITY STANDARDS: Our imaging Quality Management System (iQMS) is designed to exceed industry standards. All inspections by FDA and EMEA have resulted in zero observations, clearly demonstrating our leadership in quality. • EXCEPTIONAL STABILITY: IE has experienced a decade of high growth with no ownership change or executive leadership change in over five years.
Caron Products is a provider of incubators & chambers for cell growth and product environmental testing in biological research, scale-up culture, and drug and biological QA/QC testing. Caron`s products are integral to workflows ranging from cell & gene therapy to medical device manufacturing. Caron`s expanding resources, with manufacturing facilities in both the USA and Europe, and a worldwide network of sales and service personnel aligns with the needs of the global biomedical industry.
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness. PhlexTMF, the company`s Trial Master File software, and Regulatory Solutions including PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for their out of the box best practices capabilities, use of automation technology, and user-focused design. PhlexNeuron, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end to end solutions offering from Phlexglobal. Phlexglobal is a PharmaLex Group company. The PharmaLex Group now has over 2,300 employees, with 53 offices in 25 countries and more than 1,000 satisfied clients worldwide.