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WHAT’S NEW – Champions of The Paperless Clinical Trial and First FDA Approval Using eSource When Entering Data in Real-Time at the Clinic Visit

Champions of The Paperless Clinical Trial and First FDA Approval Using eSource When Entering Data in Real-Time at the Clinic Visit

 

Target Health Inc. is a software company that provides CRO services, and a CRO that includes software services as part of its offering. Some of our clients just use our software, while others want us to provide CRO services, fully integrated with our software suite. In our most recent paperless clinical program in dermatology, sponsored by Big Pharma, 65% of patients electronically signed the informed consent document, and 90% of forms were entered on the day of the clinic visit; over the course of 12 months, there were just 29 monitoring visits at 13 sites, including 3 sites in Japan, while 151 central monitoring reports were issued and electronically signed. All features, including the monitoring reports, were at one website with no dedicated devices. A major program is ongoing in autism and other programs are starting in psychiatry and diabetes.

 

The first-ever FDA clearance of a direct data entry, eSource program, occurred in 2015.  There were FDA inspections at 3 medical centers and at Target Health; and only one 483 at one of the sites, which was easily addressed. The results were recently published in JAMA.

 

Below describes our software suite:

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. 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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