genae offers cutting edge solutions that may change clinical research practice and improve workflow, quality, accuracy and speed.

Life science companies are continuously looking for ways to improve clinical research to achieve faster time to market and reduce costs related to development and research. Big data analytics and new clinical technology - such as mobile health solutions and wearable devices - will impact the way trials are conducted and how an increase in data equity and scientific knowledge may be achieved.

Wearable technology
Wearables i.e. accessories incorporating computer and advanced electronic technology, are emerging as a solution for creating a more adept and effective clinical trial process. Although the technology is in an early phase, there are clear benefits of using wearables in the clinical trial setting such as computational power and predictive analytics tools which enable a volume increase of the collected data, and improved workflow processes and speed, which ultimately may lead to decreased health care costs while achieving faster times to market.

INTEGR8 study
genae launched the INTEGR8 study in July 2015 to demonstrate and validate the integration of a wearable device (Microsoft Band) in an EDC (edc2go). The INTEGR8 program combined:

  • daily quality of life related questions
  • sent from edc2go, and answers transmitted to a smart-phone (Bluetooth) and encrypted (3G/WIFI) to edc2go
  • 19 subjects across 4 countries
  • follow-up of 1 month

The study illustrated the possibility of storing and processing real-time data, from patient to data collection workflows. Not only did the study design demonstrate a 2-way communication between wearable and EDC; it also achieved a next level of intelligence by correlating data entries. Throughout the study, smart questions were triggered when subjects provided specific answers for 3 consecutive days.

genae has already initiated two follow-up studies to optimize data collection workflows and to expand data collection with tracked quantifiable and objective metrics such as the wearer’s heart rate and steps walked. These studies will be rolled out in 2016 and genae aims at commercializing this novel technology in the next 12 to 24 months.

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From an investigator’s perspective, the integration of this wearable technology in data collection workflows may have a positive impact on patient compliance and medical costs.

Dr. Stefan Verheye

ZNA Middelheim, Belgium

Lower study costs with hybrid monitoring

The genae difference

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