The FDA has cleared for marketing a medical cooling device from Lund, Swedenbased Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.
The Society for Clinical Research Sites (SCRS), the trade organization representing over 2,600 global clinical research sites in 42 countries, announces today the finalists for the 2015 SCRS Eagle Award.
Dr. Jules Mitchel shares what it's like being an inspiration to the industry, how he inspires his team and peers, who has inspired him, and the innovations he is seeing in the industry.
PharmaVOICE interview with Dr. Jules Mitchel, the Commander in Chief of Target Health, Inc.
Dignitana AB announced that the company has submitted for review an application to the US Food and Drug Administration (FDA) Center for Devices and Radiologic Health for approval of the DigniCap™ System. Dignitana engaged the Clinical Research Organization (CRO) Target Health Inc., with offices in New York, in 2011, and Dignitana has been working in close collaboration with Target Health to interact with FDA, conduct the pivotal clinical trial and prepare the FDA application.
When original data are captured through validated electronic systems, there is no need to perform source document verification (SDV)> The key to regulatory compliance becomes the availability of validated, independent, contemporaneous copies of source records.
The Society for Clinical Research Sites (SCRS) is pleased to recognize and welcome Target Health, Inc., an industry leading full service eCRO, as a new Site Development Partner.
Target Health and Life-On-Key are pleased to announce that Year 2 of a 2 year project, sponsored by a grant from the BIRD Foundation, has begun. The goal of the project is to integrate any electronic medical record (EMR) with any electronic data capture (EDC) system used in clinical trials.
Target Health is a Made in NYC health company, founded by couple Jules Mitchel and Joyce Hays. Serving the pharmaceutical community since 1993, the company has met incredible success in its 20 years through innovative optimization of drugs, biologics, and devices.
Target Health Inc., and TechnoSTAT Ltd., are pleased to announce a strategic collaboration to provide high quality and competitively priced 21 CRF Part 11 compliant electronic data capture (EDC) and paperless clinical trial solutions to Israeli life science companies.
Target Health Inc., and LifeOnKey Inc., announced at CLINTECH 2013 that they are recipients of a $900,000, 2-year award from BIRD Foundation. The award, entitled, “EMR/EDC HUB - An Electronic Bridge between Medicine and Science," will integrate the EMR with electronic data capture (EDC) systems for clinical trials.
Newest version of the company’s Internet-based Document Management and Document Sharing Software.
Target Health was Protalix’s CRO partner and together with Cato Israel, who monitored outside of North America, we took this product from toxicology to the pre-IND meeting, IND submission, Phase I, Phase III, Orphan Drug, Fast Track, Expanded Access, multiple FDA meetings and now the eCTD NDA submission.
Robust Document Management Solution for Clinical Trials.
Target Health, Inc is one of thirty-five leading organizations from the clinical research community have pledged support for new initiative.
According to Target Health’s President, Dr. Jules T. Mitchel, “Target e*CRF Version 1.7 was developed in close partnership with one of Target Health’s premier clients, and is based on input from all areas of the clinical trial process, including trials management, data management, and biostatistics.”
Target Health, Inc. is one of the twenty-seven leading organizations from the clinical research community have already pledged support.
CytoDyn, Inc. (Pink Sheets:CYDY) has selected Target Health, Inc. for the preparation and electronic filing of CytoDyn’s upcoming FDA application using Target Health’s proprietary e*CRF® system.
"This alliance delivers us immediate speed and efficiency to our drug development efforts resulting in quality clinical trial data at high levels of regulatory compliance," stated Tom Davis, arGentis' Chief Executive Officer. "Target Health's proven track record of NDA and PMA approvals verifies that we will be able to accrue valuable clinical study performance through enhanced planning and achieve favorable end points to our trials."
Newest version of the company’s Internet-based Document Management and Document Sharing software.