OVERVIEW

Clinical data management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration, and availability of data at appropriate quality and cost. It also supports the conduct, management, and analysis of studies across the spectrum of clinical research.

 

The Objective

Opera’s EDC provides a solution that assures:

  • Greater Control Over Your Study

Rapidly configure protocols, eCRFs using intuitive tools that require no programming. Monitor your study progress in real-time.

  • Higher Quality Data

Streamline data capture from clinical professionals. Powerful tools for ensuring accurate and timely data.

  • Supports all phases and types of studies.

 

EDC Clinical Trial Design

The EDC solution allows for a systematic approach for the Clinical Trial Design. A checklist is provided automatically by the system that guides the Data Manager through all the important steps and components that compose a finished electronic Clinical Trial.

 

EDC’S APPLICATION MAIN FEATURES

 

User Role Management

The EDC solution offers multiple user roles with specific permissions that follow the workflow of a typical clinical trial.

 

CRF Design

The EDC solution allows for the creation of CRFs in a flexible way with options ranging from simple drop-downs and multiple selections to validation rules for data entry values etc.

 

Compliance and Security

The EDC solution is compliant with the GCP/ICH rules, 21 CFR Part 11 and EU applicable Directives.

 

Clinical Trial Design

Integrated study design workflow, allows for a systematic approach in creating and managing clinical trials in the EDC solution.

 

Client – Server Web Architecture

Server – client architecture allows maximum flexibility as the system requires only a browser application on the client side.

 

Data Export & Import

Automated and manual capabilities for importing, exporting, and exchanging clinical trial data.

 

Integrated Audit Trail

The integrated audit-trail system records all changes and actions performed in the system and offers easy access to the information in the user interface.

 

Datasets

Based on the user role and permission type, data sets can be created any time during the duration of the Clinical Trial. The data can be exported using flexible criteria and multiple formats – e.g. CDISC, SPSS, XML, CSV etc.

 

Serious Adverse Event reconciliation

The CRF collects adverse events reported during the conduct of the clinical trial however there is a separate process which ensures that Serious Adverse Events are reported quickly. The clinical data manager must ensure that data is reconciled between these processes.

 

Database Finalization and Extraction

Once all expected data is accounted for, all data queries closed, all external data received and reconciled and all other data management activities complete the database may be finalized.

 

EDC’S SOUTION MAIN ADVANTAGES

 

Sites

Keep sites productive and compliant

Give sites an easy, and intuitive way to provide accurate study data. Auto-notify site users with actions required. Auto-manage study calendars.

Apply electronic signatures.

 

Data Managers

Maintain control over your study data.

Powerful tools for centrally reviewing data, resolving queries, and flagging discrepancies. Sophisticated edit checks to ensure accurate data capture. Maintain accurate data to close studies faster. Aggregate data from disparate sources. Provide data to stakeholders in useful formats. Tools for study closeout.

Monitors

Simplify your monitors’ work.

Give your monitors a mobile friendly dashboard to assist them in the field, showing what they need to do, and when they need to do it. Review site activities, verify data against source.