eSource and Direct Data Entry – 2 New Programs in Oncology
Target Health is pleased to announce that it has received 2 new programs in oncology that will utilize Target e*CTR® (eClinical Trial Record) fully integrated with Target e*CRF®. The programs will be at major oncology centers in the US.
Target e*CTR allows the clinical study sites to perform direct data entry into any EDC system. This patented process generates a read-only, human readable electronic document, which can be designated as the primary source data (eSource). These records, maintained in a secure, read-only trusted 3rd party environment, are available to the clinical study sites, monitors and regulatory agencies in a human readable format, and carry a full audit-trail.
These 2 new studies under 2 INDs add to the 11 studies under 6 INDs which have utilized Target e*CTR. Bottom line, around 3% of forms are queried and about 1% of forms are being changed. We can assure our readers that the changes made to the database do not affect patient safety, data integrity, data quality and trial outcomes. What is happening is that data are entered and reviewed in “real time,” and when the study subject leaves the clinic, there is virtually no more work to do till the next visit.
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.