2015 NORD Meeting


Last week, Target Health attended the NORD annual meeting, held in Crystal City, VA and participated on a Panel entitled “The Path to Progress – Rise in Orphan Drug Approvals and Breakthrough Designations.“ The Panel was chaired by Dr. Gayatri Rao, Director Office of Orphan Products Development and Panel members included, in addition to Dr. Jules Mitchel, President of Target Health, Dr. Peter Marks, Deputy Director, CBER; Dr. Jeff Allen, Executive Director, Friends of Cancer Research and Dr. Amit Sachdev, Executive Vice President, Policy, Access and Value, Vertex Pharmaceuticals.


The meeting was attended by over 400 participants with a major presence by patients, patient advocates and FDA and was inspirational.




Quality by Design (QbD) and Risk-based Monitoring Presentation at CBI Conference


On November 5-6, 2015, at Hilton Philadelphia City Avenue, Dr. Jules Mitchel, President of Target Health will be presenting a Case Study on Risk-Based Approaches to Clinical Trial Management. Here is a summary:


The best risk-based clinical monitoring plan starts with a well-designed protocol and if followed properly, assures patient safety and data quality. Monitoring of a trial includes risk-mitigation strategies with the understanding that not all risks have equal weight. The FDA wants to know if informed consent was obtained properly. Was the protocol followed? How was the protocol monitored? Were critical safety issues reported? Was the investigational product used as instructed? This case study will show: how risk-based trial management (and monitoring) begins with the protocol and underscores the definition of quality as the absence of errors that matter and are the data fit for purpose. The case study will also analyze metrics derived from actual studies ranging from small single center studies to studies as large as 1,000 subjects at 40 clinical sites. Dr. Mitchel will present results from a recent FDA inspection of a study using RBM where sites entered data in real time into EDC, with no paper records.


ON TARGET is the newsletter of Target Health Inc., a NYC – based, full – service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.


For more information about Target Health contact Warren Pearlson (212 – 681 – 2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.


Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor



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