Less visits. More subjects. Lower budget

No worry about data collection as measurements are collected automatically. A huge time saver for the investigator, this enables less visits in your study protocol. In addition, you can closely monitor participant compliance.

 

You will save on your budget and improve enrollment!

Safety first!

The assessment of safety is based primarily on the frequency of serious adverse events. Using telemedicine to collect vital signs increases safety for the study participant. The investigator can respond immediately when serious adverse events occur. The vital signs can be monitored during washout and also during the study to detect treatment-emergent events. This will significantly increase the safety of the study participant during the entire study period.

Reliability

Increasing the reliability of your research data has never been easier! With NetMedical's telemedicine you can avoid transcription errors in your eCRF. The fully automatic data collection avoids manual data input and with that improves the speed and quality of data collection. Individual readings can be traced back to the study participant, covering you for any audit you may face. Reliability you can count on!

Automated Self Measurements more reliable?

More clinical trials leaders are accepting automated measurements, performed by subjects at home, as a standard. It provides a simple and cost effective means of obtaining a larger consistent dataset, measured always the same way and therefore very valuable for research. Also the iModem works with top quality devices of vital signs monitor manufacturers such as Omron, A&D, CSL and Lifescan. The medical devices have been clinically validated and approved, making them very suitable for research. Home self measurements reduces white coat hypertension and improves compliance. Currently the iModem supports Blood Pressure Monitors, Blood Glucose Monitors, Weighing Scales and the Digital Pen for handwritten reports.

Gain higher compliance and response in the trials

Because the measurement data is immediately at the disposal of the investigator, they can respond directly when participants do not comply with the protocol. The investigator calls a participant or even schedules an appointment to re-instruct the participant. This continued feedback increases the compliance of participants in the trial. This will increase the amount of available valid measurements dramatically.


Automatic, Effective, Faster

Collection of vital signs is fully automatic with the iModem. Your subjects and investigators do not need to take any manual action. It is not necessary to collect prints of the measurements, copy thermo paper and manual insert the data in the eCRF. The end result: faster and higher quality data, with a lot less data cleaning activities upon study close. Enhancing the speed of data submission this way improves the analysis of study data and lowers costs on all sides.

Quick responses

If anything seems out of the ordinary, immediate response is possible. On the part of the investigator this is a time saver, especially when participants are home monitored for longer periods. In short; save time and money.



Telemedicine data primary end-point data?

Not yet. But we are getting close! NetMedical's iModem has been applied in Phase IV studies where the iModem-collected measurements were used directly to form conclusions for the research, but the clinic visits maintain to be required and regarded to be the main end-point data.


The FDA/EMEA have a positive attitude towards telemedicine in general, though. Because of the need to get the market to accept it as a means of gathering reliable end=point data, NetMedical is moving forward with seeking acceptance of the iModem system by the FDA/EMEA as primary data source for a study. Although they understand the challenges in data quality and safety, they also realize the ever stringent budget requirements and do subscribe to the concepts of the iModem system.