JAMA Publishes Results of the First FDA Approved Product that Used eSource (Target e*CTR®) to Collect and Store Real Time Data in the Clinic
Many years ago a very senior executive at Pfizer told me (Jules Mitchel, a proud Pfizer alumnus) that if you can just get a product approved that used your paperless solution, we will all jump in. He added that Big Pharma will not take the chance itself, but you guys are “crazy enough to even try, so just do it.“ Well, not only did we do it, but the results of the clinical program was just published in JAMA.
On 14 February 2017, JAMA, the Journal of the American Medical Association, (volume 317:606-614) published a paper entitled “Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer.“ Target is honored to have managed and executed this entire program, and to be co-authors on this ground-breaking treatment for women undergoing breast cancer chemotherapy.
From the clinical research operational perspective, this study was executed using Target Health’s patented, web-based, eSource solution, Target eClinical Trial Record (Target e*CTR®), which was fully integrated with Target e*CRF®, Target Health’s proprietary EDC system. Both Target Health and 3 major medical centers were subject to FDA inspections which were passed with no findings related to Target Health’s paperless clinical trial solution, and Target Health’s approach to risk based monitoring and Quality by Design. There was only one minor finding at one of the research sites related to GCP, as nothing is perfect.
Related articles include: Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials and eSource Records in Clinical Research, and more papers can be found on our website.
Sunrise in NYC
Every once in a while, the early bird catches the worm. Another spectacular sun rise looking towards Europe.
Sunrise of the 24th Floor©Target Health Inc.
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 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