Study Portal In A Nutshell

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.

Built-In Modules

eConsent

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.

Coder

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.

CTMS

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.

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