The multi-platform drug trial solution will allow patient centric data to be collected and viewed in real time to improve patient safety. The mobile phone solution will allow patients and clinicians to enter data in compliance with CFR 21 Part 11 with digital signatures and full audit trail to guarantee provenance of information.
Ease of configuration and localisation will allow the international participation and allow data transfer and analysis in line with robust clinical governance guidelines.
The platform adheres to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations.
The ease of use will facilitate medication and protocol compliance as well as allowing faster data collection for analysis and monitoring for side effects and potential unforeseen complications.
PATIENT SAFETY & COMPLIANCE
Improved patient safety due to real time alerts and reporting of adverse events. Medication reminders improve compliance
BIOMETRIC DATA COLLECTION
Cross platform data collection using mobile phone technology improves speed of data acquisition and reduces cost
OLAP reporting database allows rapid data analysis and issuing of real time and adhoc reporting. Digital signatures comply with CFR 21 to allow export of data
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