CliniOps offers a Unified Platform to support Hybrid and Virtual Clinical Trials, powered by Integrated Telemedicine. The solution is designed with study team stakeholders like you in mind, offering you the access to real-time data for informed decision making and seamless collaboration. The solution is structured to mimic the real world. As with the demands of the growing clinical trials, your CliniOps platform has time and again proven to be extremely configurable and scalable, to meet your demands of the trials spanning several therapeutic areas, and the journey through your regulatory pathways across phase I, II, III & IV trials.
The Study Portal is a single unified platform to streamline ‘Clinical data management’, ‘Clinical operations’, and accelerated ‘Regulatory submission’ processes. The efficiency and quality of several down-stream activities of the clinical trial workflow, depends on high quality & real-time data collection at source, also enabling central and remote monitoring (rSDV). Sponsors and CROs can view the data along with powerful dashboards, reports and study KPIs, via the portal with all eClinical functionalities, to support decentralized, Virtual or Hybrid trials.
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.
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.
Patient safety is the integral principle of any trial, but suddenly we now have Covid-19 situation where having patients come into clinical sites for their scheduled visits poses a significant risk to their health and well being. And not just patient alone, but also the safety of the study team, including the monitors, the data managers, the CRAs, for any activity that requires a visit to the site. CliniOps decentralized solution offers the safety and comfort across all stakeholders, with increased efficiency and highest data quality.
Clinical Data Interchange Standards Consortium (CDISC)
Society for Clinical Data Management (SCDM)
Medical Dictionary for Regulatory Activities (MedDRA)
Uppsala Monitoring Center (WhoDRUG)
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