Risk-Based Monitoring and Direct Data Entry


Target Health Inc. is pleased to announce that it has initiated 3 clinical trials using direct data entry, central monitoring and risk-based source document verification (SDV). One study has already been completed and 2 are ongoing. The following are some of the outcomes of this paradigm shift:


1. Onsite monitoring reduced by 60%

2. Screening errors picked up early

3. Real time monitoring at the time of data entry

4. No need to do additional subject recruitment

5. EDC edit checks modified early in the game

6. Compliance issues identified in real time

7. Real-time transparency of safety issues

8. Site saved 70 hours of data entry time


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  at www.targethealth.com


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