MRN has >25 years of experience in the design and management of IVD clinical studies. We have designed and implemented >100 research and regulatory trials in oncology, infectious and other diseases. We apply sound statistical design principles, and have the capability to recruit and initiate multiple centers to support enrollment rates to meet the most aggressive timelines. With extensive industry experience, MRN offers many clinical study design solutions to minimize time and cost.
We have written, designed and managed over 20 FDA submissions including 510(k), PMA, and HUD classifications. We are experienced with most diagnostic assay formats and technologies, Companion Diagnostic testing, and requirements for Analyte Specific Reagents, RUO and IUO classifications. We also have extensive experience with the design of clinical and regulatory strategies to support commercialization of Laboratory Developed Tests.
With over 50 published full-length manuscripts in peer-reviewed journals, MRN provides comprehensive medical writing leading to successful manuscript publication. We are expert in data analysis and presentation, manuscript design, writing, and submission electronically or in hard copy format. Authorship or Acknowledgment of manuscript writing follows published guidelines to minimize concerns around “ghost writing” of published manuscripts.
MRN has designed and led dozens of Scientific Advisory Boards for various purposes including strategic R&D direction, guidance in new product commercialization, and clinical trial design and management. With our experience in recruiting high quality faculty, board meeting design and meeting leadership, your Advisory Board meeting will be guaranteed to achieve internal objectives. We also provide ancillary Ad Board services such as Executive Summaries and Physician Educational Programs designed to bring important scientific and medical information to large numbers of clinicians across the globe via printed journal supplements or a wide variety of internet activities.
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