Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 10, 2011
New Medical Device Integrations at CRF Health
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CRF Health
announced new medical device integrations to support both spirometers and glucometers used in Phase I-IV respiratory and diabetes clinical trials. CRF Health’s eDiary TrialMax® platform now integrates with Entra Health Systems’ Bluetooth-enabled MyGlucoHealth Wireless Meter and Vitalograph’s Asma-1 electronic Peak Flow Meter.
The wireless integration of our eDiaries with these medical devices results in more accurate data by removing the need for manual transcription of the data values. The date and time stamp of the reading and the device serial number are also transferred, providing evidence of the timeliness of the data and an attributable source. Once the eDiary receives the values from the glucometer or PEF meter, the values can automatically be sent to the ePRO database for review by the site personnel or study team. This allows very close to real-time monitoring of the subject’s status and permits timely intervention for safety or compliance concerns.
Benefits for clinical trial Sponsors include:
· Near real time access to all patient-generated data
· Defensible data that meets the FDA’s ALCOA standard
· Ease of use – no wires or cradles to connect
· High compliance to protocol (reminder alerts)
· No data transcription errors
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