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.
CliniOps EDC module supports all the clinical data management activities that are performed throughout the study including study setup, study conduct and study closeout 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 dashboards, reports, analytics and several rich capabilities. Instant access to the study data shortens study timelines, lowers cost, and significantly increases data quality. Data can also be seamlessly exported in various formats including but not limited to xls, CDISC odm, xpt, pdf et al.
CliniOps eConsent module facilitate the consent process. CRO can use this module to monitor the compliance of the sites’ consent process without compromising on patient PHI information. PHI information is redacted based on access control. Signed informed consent forms with the time stamp and geo location can be accessed through this module.
CliniOps offers remote video interaction between CROs and sites for site initiation and other remote monitoring activities. CliniOps also offers remote source data verification through centralized access control of specific users to access site data remotely. In addition, data that requires SDV are configured ahead of time that drastically minimizes the on-site SDV effort, since most data is collected as electronic source (eSource) at the site, and may not need SDV. The ability to remotely perform this task in lieu of on-site SDV saves significant time, money and effort, reduces travel to sites, and keeps the study moving forward without interruptions.
CliniOps Coder module provides auto-coding functionality with speed and accuracy to support coding for any clinical trial, including customizable 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). This module seamlessly integrates with EDC and Coded values are stored directly within the CliniOps EDC database.
CliniOps IRT module (Interactive Response Technology) leverages interactive web response systems (IWRS) to support patient randomization for blinded studies. CROs can use this module to monitor the IP inventory at site on a real-time basis and take decisions accordingly.
CliniOps eTMF module is architected out of the DIA Reference model, and brings the trial master file requirements from source, to provide the clinical trials a very rich trial experience. End to End Audit Trails, helps you stay inspection ready throughout the study, and meet any inspection and compliance requirements. The eTMF module also offers customizable dashboards to keep track of essential study metrics on document status.
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 built-in modules. This module offers comprehensive management of trial planning, document management, country and site progress, monitoring activities, along with state-of-the-art reporting capabilities.
CliniOps Data Science for Life Science feature has built-in Artificial Intelligence (AI), Machine Learning (ML) and Natural Language Processing (NLP) capabilities. These capabilities can be put to good use to help the Study team to streamline operations, proactively take informed decisions, leverage the power of data science. The Analytics is based on intelligent algorithms to analyze study trends and patterns. These features can be used across a wide variety of use cases across Study Setup, Study Conduct and Study Closeout activities.