Key Features of ClinicalCloud®

e-Research Chart

The investigator generates, collects and records data in support of the clinical trial, which are then stored in one central location: the e-Research Chart. ClinicalCloud® provides a robust solution for recording, filing and storing of data generated in support of the trial.
  • ClinicalCloud® tools and templates allow you to create forms tailored to the study protocol. The system's hybrid forms allow both free handwriting and structured data capture within one single form. As each procedure is completed, the data is recorded electronically using the motion computing e-tablet.
  • The intuitive application ensures the completeness and consistency of the data collected. Electronic capture of data eliminates problems with legibility and attributability.
  • A procedure or document can be added to the study visit at anytime giving the application the desired flexibility.
  • Data coming from external sources, but associated with the subject visit (e.g., IVRS notifications, laboratory reports, imaging reports, etc.), is managed through document management workflows and filed in the e-chart. External documents can be received through e-mail, fax and scanned documents.
  • Documents that need approval or assessment can be routed to the appropriate study personnel through preset workflows.
  • Data is protected from unauthorized access through role-based access. Investigator and authorized study staff have immediate access to study data through a number of views.
  • Secure computer generated audit trails record the date and time of operator actions for complete transparency.

Dashboards / Workflows

  • Personalized dashboards provide single-click access to patient visit schedules and to analytical and collaborative tools, which are all easy-to-read and instantly actionable.
  • Instant notifications let you know about critical events. These alerts can be data, schedule or event driven.
  • Pre-defined workflows (which automate the manual process) previously required paper to record and monitor activities, but with ClinicalCloud® you increase individual productivity and accelerate team processes.
  • Documents that need assessments and approvals—such as lab documents—are tracked electronically ensuring compliance.

Clinical Workspace

The Clinic Workspace serves as a control center for the site/investigator. All study-related communications such as documents, activities and tasks can be found here.
  • The investigator site file and other study-related documents will be accessed and managed from this control-center.
  • Access to site/personnel calendars.
  • Predefined, protocol-specific visit calendars.
  • Personalized Dashboards and alerts, track all tasks related to the clinical trial.
  • Access finance tools for billing and reconciliation.
  • Preset reports generate study logs (screening/enrollment log, ICF log, etc.)

Clinical Research Associate (CRA) Workspace

The CRA Workspace provides tools for all study-related communication activities and tasks.
  • The CRA dashboard alerts, efficiently track all tasks related to the clinical trial and sites.
  • Communication and issue-monitoring tools help create and track communication and site issues.
  • Remote-access of source documents for study monitoring.
  • Monitor visit scheduling and tracking through CRA/study calendars.
  • Generate multiple reports associated with monitoring activity.

Management Workspace

The Management Workspace provides access to tools and metrics that aid in management decisions and risk mitigation. In the Management Workspace you'll have access to:
  • Study dashboards
  • Study calendars
  • Real-time recruitment metrics
  • Data metrics
  • CRA/CRC performance metrics
  • Site-performance metrics
  • Compliance metrics
  • Push and pull data from investigator portals in real-time (e.g., regulatory documents, newsletters and updates, etc.)

Communication Portal

The Communication Portal provides a centralized location for accessing and sharing all study-level information.
  • Directories with contact information for all study personnel including external vendors.
  • Study library serves as a repository for study-related training tools and documents.
  • Study news updates and alerts.
  • Supply order/re-order forms.