Home > ClinPlus eClinical Overview
The ClinPlus eClinical Platform combines our electronic data capture (EDC), interactive web response system (IWRS), clinical trial management system (CTMS) and electronic trial master file (eTMF) software into one, easy-to-use platform that maximizes productivity while minimizing risk. The ClinPlus suite of software is designed to be flexible and is delivered via a compliant private cloud. Whether you need the entire suite, an integrated platform or a single system, DZS Software Solutions can provide you with the exact solution you need for improved performance, visibility and coordination.
ClinPlus® Electronic Data Capture (EDC)
ClinPlus Electronic Data Capture (EDC) allows you to capture, manage and analyze clinical data more efficiently and deliver more visibility into your study. ClinPlus EDC is designed to be easy to use with no programming needed regardless of the size, phase or complexity of your clinical trial.
Key Benefits
Supports risk-based monitoring
Provides customizable workflows for data entry, review, monitoring, signing and locking
Defines simple and complex edit logic without programming
Integrates seamlessly with ClinPlus Coding
Enables optional licensing of IWRS study by study to support randomization
Integration with ClinPlus CTMS is inherent and provides real-time trial management info and metrics to clinical operations
Allows users to easily define form groups and conditional form schedules
Provides flexibility with extensive configuration tools without having to rely on software vendor
Key Features
Multi-language support
Advanced form table and form design tools
Comprehensive library of CDASH-compliant tables and forms
Includes many standard data management reports, ad hoc systems and clinical data listings
Designed to be used in a 21 CFR Part 11 and HIPAA compliant environment
Enables you to manage global contacts, project and site teams
Role-based security and access controlled at the system, domain, project, country and site levels
Allows you to define tool-tips and author form-specific data entry guidelines and instructions
Complete in-line query management
Interactive Web Response System (IWRS)
Interactive web response system (IWRS) services can be customized to provide the exact level of functionality required for your study, including group limits, auto group assign, support for blinded/un-blinded studies and randomization.
ClinPlus® Clinical Trial Management System (CTMS)
ClinPlus Clinical Trial Management System (CTMS) is designed specifically to help sponsors and CROs overcome the technical challenges associated with managing clinical trials. By improving user accessibility and communications, manual operations can be reduced and redundant data and tasks can be eliminated, resulting in more efficient workflow.
Key Benefits
Quick Study Setup - Create standard templates for project and site documents, events, milestones, site visit reports and budgets and modify as needed for each study. Sites, site teams and project teams are assembled from global contacts and global institution files.
Superior Document Management - Electronic trial master file (eTMF) structures may be defined for document organization. Documents may reside in the CTMS database, Microsoft SharePoint or in a directory structure. Document sharing, notifications for expired or expiring documents and collection statistics are included.
eTMF Harmonization - ClinPlus CTMS and eTMF integration delivers a simplified, cost-effective process of managing, tracking and storing documents within a single system. By using the included Drug Information Association (DIA) reference model, sponsors and CROs can easily define a project-specific TMF structure.
Fully Integrated Monitoring Tools - The calendar feature, integrated with Microsoft Outlook, allows project managers to view the project team’s schedule easily. The fully integrated site visit report (SVR) tool simplifies SVR creation, eliminates duplicate data entry and supports review and workflow management each step of the way.
Excellent Project Insight - Enrollment rates, document collection and milestones are displayed graphically for projected versus actual values. More than 100 statistics, maintained for projects, countries and sites, may be included on the dashboard and in more than 80 standard reports.
Study Finance Management - With ClinPlus CTMS, you can define site-specific budgets from a default budget template, track accrued payments and future obligations, define automatic or manual approval of each payment type and produce invoices on behalf of investigators.
CTMS/EDC/IxRS Integration - ClinPlus CTMS supports web services technology to provide seamless, automatic integration with many popular EDC and IxRS products. For systems not supporting web services, integration is supported via an export/import mechanism. Our ability to integrate with Rave EDC has helped ClinPlus become the first to earn Medidata Technology Partner status.
CTMS Implementation - ClinPlus CTMS is available as a cloud-based solution or can be installed on site. The system is installed preconfigured to common industry standards, while any client- and study-specific configurations are easily accomplished using the built-in configuration modules so custom programming is not required.
ClinPlus product specialists are available to help bring the system to production status quickly with minimal costs.