CliniOps App Suite is purpose-built to address several data challenges currently prevalent in large global clinical trials. It streamlines ‘Clinical data management’ with ‘Clinical operations’, and accelerates ‘Regulatory submission’.
The efficiency and quality of a lot of the down-stream activities of the clinical trial workflow, depends on high quality & real-time ‘data collection’ at source, the first step in the ‘Journey of the Data’. Most large studies in global settings with sites not only just across US and Europe, but also across Africa, Asia and other resource poor settings, face significant challenges with technology adoption that negatively impacts quality data collection at source.
The application is designed with the following in mind for seamless source data collection at sites, with significant downstream benefits for sponsors and CROs:
The source data collection at the site is kept very simple. The application runs on standard mobile devices (iPads, Android tablets) in a complete offline mode, enabling the study coordinator to be fully functional without any dependency on network connectivity. All ‘edit checks’ also run at the point-of-care in complete off-line mode, ensuring a very clean and high quality data collected digitally at the point of care. Once the source data is collected offline, it periodically uploads the data to the central repository.
Sponsors and CROs on the other hand can view the data along with powerful dashboards, reports and study KPIs, via a web portal with all eClinical functionalities that are available as part of the App Suite. In addition, there are a host of innovative features that fully automates and streamlines the clinical trial workflow, including downstream activities such as data management, query resolution, statistical programming and ADaM, SDTM datasets.
The CliniOps App Suite modules are briefly described below:
CliniOps eSource solution is a mobile, cloud-based digital solution where data is collected at sites, via mobile devices, 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 App Suite.
CliniOps EDC module supports all the clinical data management functionalities throughout the study conduct phase. Data managers can generate real-time queries and engage with the sites in collaborative manner, while Data monitors get instant visibility of study KPI’s with real-time reporting, analytics and several rich capabilities. Instant visibility of the study data shortens study timelines, lowers cost, and significantly increases data quality.
CliniOps ePRO module is designed to engage patients via smartphones, allowing them to report outcome data remotely and more frequently. This module 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 also be collected from home via IoT devices if needed. CliniOps supports medical device integration with its mobile application.
CliniOps eICF module ensures patient understanding of the study requirements and expectations and enforces study compliance. The module provides a controlled workflow with checks and balances to ensure the consent form is signed before any other study data is collected. The patient signature is seamlessly captured on the mobile device, along with the geo-location and the system-timestamp during the consent process. This 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.
CliniOps Coder module provides auto-coding functionality with speed and accuracy to support coding for any clinical trial, including workflows for manual coding when needed. This module maps verbatim terms to standard codes based on World Health Organization Drug Dictionaries (WHODrug) and the Medical Dictionary for Regulatory Affairs (MedDRA). Coded values are stored directly within the CliniOps EDC database.
CliniOps IRT module (Interactive Response Technology) leverages interactive web response systems to support patient randomization for blinded studies. Randomizing study subjects into different treatment arms may introduce study subject bias during randomization, but CliniOps IRT simplifies randomization and minimizes the bias in study subject allocation using sophisticated statistical methods.
CliniOps CTMS module is designed to monitor study progress and performance, along with tracking deadlines and milestones. This module supports the clinical operations team with an adaptive framework, and exceptional breadth of functionality that enables rapid and flexible deployment, all with the power of other App Suite modules built-in. This module offers comprehensive management of trial planning, country and site progress, monitoring activities, along with state-of-the-art reporting capabilities.