The Site App is purpose-built mobile application that helps with the high quality & real-time electronic data collection at source (eSource). The application runs on standard mobile devices in a complete offline mode, with all ‘edit checks’ enabled, ensuring a very clean and high quality data collected digitally at the point of care. The application has built in functionality to support electronic consent, telemedicine, Randomization. It also supports IP Management and integration with EHRs and Lab systems for a smooth end-to-end digital dataflow.
CliniOps eSource solution is a mobile, cloud-based digital solution where data is collected at sites, via mobile tablets, with complete offline functionality. Powerful edit checks within the eSource solution ensures that data collected at the ‘point of care’ is of the highest quality. Data is then automatically uploaded in near real-time to the central data hub, once network connection is available. CliniOps eSource solution has been designed as per FDA guidelines and the data collected on the mobile device is considered ‘source data’ (aka eSource), that eliminates the need for a separate paper record. Data can then be accessed and analyzed by the different modules of the CliniOps Suite.
CliniOps eConsent module ensures patient understanding of the study requirements and expectations and enforces study compliance. This allows the sites to conduct the eConsent process either in-person or remotely, including Ascent, LAR (Legally Authorized Representative) and other modes of consent. The module provides a controlled workflow with checks and balances to ensure the consent form is signed before any other study data is collected. During the consent process, the patient signature is seamlessly captured on the mobile device, along with the geo-location and the system-timestamp. Thus making the whole consenting process completely paperless and transparent. It also has the capabilities to ensure that the patient has the appropriate understanding of the study before they provide the consent.
Telemedicine module offers the study team the option to interact with the patient, via a secure digital platform. The study team can initiate the interaction via the mobile app, or the web portal, over a built-in video conference functionality to connect with the patient on his/her Smartphone, Tablet or Web browser. This not only allows the site, an option to convert some in-person patient visits to tele-visits but also significantly increases the outreach for patient recruitment and brings diversity in clinical trials. It also helps with patient retention, increases patient engagement and protocol adherence, by constantly interacting with patients via alerts, reminders and notifications.
CliniOps eIRT module (Electronic Interactive Response Technology) leverages various web and mobile technologies to support patient randomization for blinded studies. It can support studies with simple randomization to complex stratified randomization including cross-over trials. It also simplifies the process of assigning randomization codes based on barcodes and minimize errors.
CliniOps offers standard APIs to integrate with 3rd party applications. Electronic Health Records have remained isolated Islands for years. Now, with CliniOps and its partner ecosystem, you have access to over 450 sites, available with integrated EHR to EDC data to get your clinical trials started rapidly. SMART on FHIR standards for data transfer GCP-compliant process for controlling the data. CliniOps is agnostic to the Data Source and makes standardized data available from over 55 EHR systems.
CliniOps offers standard APIs to integrate with 3rd party laboratories. A study can get data from one or more central labs and each lab can be configured for lab normal ranges based on the protocol and lab manuals provided by the labs. CROs can get near real time access to lab data and reconcile those with the study data to speed up the review process and make faster decisions.