The Patient App makes the clinical trials more Patient Centric by enabling data collection via telemedicine, with patients at their homes or at their normal care facility. It also helps increase Patient Engagement and Retention with regular reminders, notifications, alerts as needed, which also helps with the adherence as patients stay engaged and alert. The Patient App also increases a much wider Patient Outreach in resource poor areas which otherwise would not have been possible to reach, including newer geographies, usually considered very remote and difficult to operate. This can either be the ability to reach patients who lives several hours away from the research site, or access to newer patient pool in Africa, Asia and the like.
Telemedicine module offers the patient the option to interact with the physician and/or nurse, from the comfort of their home. This is conducted via the mobile app over a built-in video conference functionality on the patient’s Smartphone, Tablet or Web browser over a secured network. So, patient has the choice of an onsite visit, tele-visit, or even a home visit by a mobile visiting nurse or a phlebotomist. This significantly increases patient retention, patient engagement and protocol adherence.
CliniOps eConsent module ensures patient understanding of the study requirements and expectations and enforces study compliance. This module guides the subject through the consent process so that they can get all the right information regarding the risk and benefits in the trials and hence make more informed decision regarding enrolling in a study. Subjects can sign the informed consent either in-person at the clinic or remotely over a tele-visit session.
CliniOps eCOA module is designed to engage patients via smartphones, allowing them to report clinical outcome data remotely and more frequently. Supports rapid configuration and rollout of standard eCOA instruments, including Quality of Life Questionnaire (QoL) instruments for measuring the quality of an individual's life across a broad range of specific areas. Patient outcome data can be collected on either a provisioned device or in a BYOD (Bring Your Own Device) model. It also supports automated alerts and notifications to both patients and sites, via SMS, email or push notifications, as configured.
CliniOps ePRO module is designed to engage patients via smartphones, allowing them to report patient data remotely and more frequently. It also allows for seamless site-patient interactions, with various patient engagement features. This module has proven to increase both patient retention and protocol adherence. Patient data can be collected on either a provisioned device or in a BYOD (Bring Your Own Device) model. It also supports automated alerts and notifications to both patients and sites, via SMS, email or push notifications, as configured.
CliniOps mobile app can seamlessly connect with several wearables, sensors and connected devices. CliniOps system is integrated with devices to collect heart rate, blood oxygen, electrocardiogram, respiratory rate, blood pressure, temperature et al, to name a few. Device data is collected via the app from patient home and is transmitted to the patient database that can be accessed securely by the study team based on their access control. The system supports several data formats including alpha, numeric, image, voice, video, wave formats etc. CliniOps also has built in real-time alerts, that gets triggered if the device data shows abnormal fluctuations, or beyond normal ranges.
An important aspect of decentralized trials is to keep the patient constantly engaged with the study team. This will ensure that the patient dosent feel disconnected and gradually gains the confidence and gets comfortable with the remote model. One important way to achieve this, is to keep the patient constantly aware of study related details throughout the process. The Patient App supports study documents, videos, newsletters and other related information that can be shared by the study as the study progresses.