eCLINICAL PLATFORM

The ClinPlus eClinical Platform combines

our electronic data capture and clinical trial
management system software into one,
easy-to-use platform that maximizes productivity
while minimizing risk. Through superior data
and trial management, this innovative platform
keeps clinical trials running efficiently.

DZS Software Solutions, Inc. | 1661 Route 22 West, Bound Brook, New Jersey 08805
sales@clinplus.com | www.clinplus.com | 732.764.6969

ClinPlus eClinical Platform

The ClinPlus eClinical platform is an affordable, cohesive product that integrates electronic data capture (EDC), interactive
web response system (IWRS), clinical trial management system (CTMS) and electronic trial master file (eTMF) features
into a unified, easy-to-use platform. The ClinPlus suite of software is designed to be flexible. 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.

Benefits of the eClinical Platform:

Uses a single sign-in to access a role-based user interface for all eClinical components.
Eliminates redundant tasks, reduces errors and simplifies training by centrally managing system and project security,
global contacts and institutions, project design, reports, alerts and notifications.
Takes advantage of real-time visibility of key performance indicators to proactively identify problems at an early stage.
Keeps projects on track with a broad array of portfolio, project, site and enrollment metrics.
Gauges investigator performance ratings using objective and subjective data from both the CTMS and EDC modules.
Replaces EDC/CTMS integration with simple mapping and seamless web APIs when integration with third-party
systems is required.
Enables you to license EDC, IWRS and CTMS modules together or separately on a project-to-project basis. Should
you need to license separately, ClinPlus CTMS will integrate with virtually all EDC and IVRS systems and Microsoft
SharePoint. It also includes intelligent tools for importing and exporting global and project-specific data.

Support and Training

All product design, development and testing are performed by our in-house staff at DZS Software Solutions. Our responsive
support staff will address any questions quickly and accurately. Initial on-site training, topic-focused webinar sessions and
eLearning modules are available.

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 of ClinPlus EDC:

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
Internal links to ClinPlus CTMS eliminate necessity for integration and provide real-time
trial management info and metrics to clinical operations
Easily defines form groups and conditional form schedules
Extensive configuration tools provide flexibility without having to rely on the software vendor

Key Features of ClinPlus EDC:

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 system 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.

Learn more about the ClinPlus eClinical

Platform at clinplus.com/eclinical

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 workflows.

Key Benefits of ClinPlus CTMS:

Quick Study Setup: This creates standard templates for project and site documents, events, milestones, site visit
reports and budgets, which can be modified as needed for each study.
Superior Document Management: Electronic trial master file (eTMF) structures may be defined for document
organization, including document sharing, notifications for expired or expiring documents and collection statistics.
eTMF Harmonization: ClinPlus CTMS includes eTMF functionality to deliver a simplified, cost-effective process of
managing tracking and storage of documents within a single system.
Fully Integrated Monitoring Tools: The fully integrated calendar simplifies scheduling and site visit report (SVR)
creation, eliminating duplicate data entry and supporting review and workflow management.
Excellent Project Insight: Enrollment rates, document collection and milestones are displayed graphically for
projected versus actual values, with more than 100 statistics that may be included on the dashboard and in more
than 80 standard reports.
Manage Study Finances: 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 provides seamless, automatic integration with many popular EDC and
IxRS products, supported via a seamless web services interface, earning ClinPlus the Medidata Technology Partner status.
CTMS Implementation: Deployed as a private cloud solution in a secure, SOC 2 certified data center, the
system is installed preconfigured to common industry standards, with specific configurations to make custom
programming obsolete.

Learn more about the ClinPlus eClinical Platform at clinplus.com/eclinical