DZS/ClinPlus® Introduces ClinPlus CTMS 2.0 with Enhanced Functionality including Framework for Integration with Medidata Rave® Electronic Data Capture System

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Clinical Trial Management Solutions Organization Introduces ClinPlus CTMS 2.0 Offering New Software-as-a-Service Model, Integrated Site Visit Report Tools and Automatic Sharing of Trial Data with Medidata Rave EDC/CDM System and others

DZS Software Solutions, a specialty provider of ClinPlus® clinical data and trial management services and solutions, today announced the availability of ClinPlus CTMS 2.0. The latest version of ClinPlus CTMS 2.0 offers pharmaceutical, biotech and medical device sponsors and contract research organization (CROs) customers simplified delivery under a new SaaS subscription model in addition to traditional installed and 3rd party hosted delivery options. Enhanced functionality enhances operational visibility beyond the capabilities of earlier versions with the addition of site visit report authoring and review workflow, automated email notification of events and alerts, scheduled report execution with email delivery, enhanced EDC integration and improved data importing capabilities.

A built-in standards-based framework supports automatic transfers of trial data from Medidata Rave®, an industry-leading system for electronic data capture (EDC) and clinical data management (CDM). The system leverages the Medidata Web Services API to automatically transfer critical trial data collected in Rave into ClinPlus CTMS. This data sharing enables sponsors to improve clinical productivity by reducing the amount of duplicate data entry and maintenance, increasing the awareness of data changes through automated notifications and the acceleration of internal processes such as investigator reimbursement approvals. The system also supports data import and export with other systems.

“The rapid sharing of trial data between Medidata Rave and the ClinPlus CTMS will help our customers reduce their trial management burden and run more efficient trials,” says Glen de Vries, President of Medidata.

With an efficient and error-free method of bringing trial data captured within Medidata Rave into ClinPlus CTMS, DZS and Medidata can now serve their customers with rapid, automated transfers of trial data, such as patient enrollment, patient visit, dropout and discontinuance data. The integration with Medidata Rave allows users to schedule and manage import types, key fields, values, data sets and visits.

The addition of the new Site Visit Report Tool feature in ClinPlus CTMS 2.0 will enable CRAs and Project Managers to author and review trip reports, while managing the workflow from first draft through final approval. This new feature will enable clients to configure report templates based on visit type and country, and to integrate CTMS data directly into the trip report. Unlike many other trip report authoring tools, the data entered by the CRA while creating the report is deeply integrated with the main features of the CTMS to reduce data redundancy. Updates to system data elements commonly found in the trip report sections such as regulatory documents, issues, enrollment, SAEs and deviations are done while creating the report and do not need to be re-entered into other areas of the system.
The availability of ClinPlus CTMS in a SaaS delivery model is another extremely important and timely development for many emerging Life Science organizations struggling with the challenges of improving clinical trial productivity while at the same time reducing expenses.

"The appeal of our new SaaS delivery model is its immediate availability to Life Science organizations of all sizes, and its ability to accommodate a wide range of the requirements needed to quickly and effectively deploy the software and get clinical studies up and running in weeks and not months,” said Bob Borysko, DZS’s VP of Product Development. “By improving global user accessibility and communications, tremendous efficiencies and time savings can be realized, manual operations can be reduced and redundant data and tasks can be completely eliminated.”

"DZS continues to focus on improving clinical trial productivity in all phases of the clinical trial process by using technologies that leverage the value of trial data and improve the quality of that data to support regulatory approval for new compounds and medical devices. Our partnership with Medidata Solutions positions DZS to take advantage of a leading EDC breakthrough solution that is quickly becoming a major force in the drug development arena,” said Doron Steger, CEO, DZS Software Solutions.

To speak to a product expert or a personalized demonstration, please contact salesandmarketing(at)clinplus(dot)com or visit http://www.clinplus.com/ctms-landing---clinplus-clinical-trial-management-copy

About DZS Software Solutions, Inc.
DZS Software Solutions, Inc. is a privately held company founded in 1996 providing clinical trials software for clinical data management and analysis to the biotech and pharmaceutical industry worldwide. Over 50 clients globally presently use ClinPlus® software for data collection and capture, data cleansing, coding, analysis, clinical trial management and reporting. When the software is coupled with DZS services and training, many ClinPlus clients have dramatically improved productivity and maximized the value of clinical research investments and gained a competitive advantage to get medicines and products to market faster.

The ClinPlus® Software Solutions Suite for Clinical Trials provides premium tools required by pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers to expedite clinical trials and meet the strict data formatting requirements of the FDA and other global regulatory agencies.

The ClinPlus® Software Solutions Suite’s unmatched cost-of-entry, scalability, flexible delivery options and exceptional training and support have gained DZS a reputation for delivering exacting quality and helping clients achieve early visibility to reliable clinical data. DZS software engineers possess decades of statistical analysis, clinical data management, clinical project management, and ADE/Drug coding and table/list/report building experience. This real-world experience is incorporated into every ClinPlus® system design and is evident in the reliability and enhanced features found in every system!

Keith W. Ward
Director of Global Marketing & Sales
DZS Software Solutions, Inc.
1661 Route 22 West,
Bound Brook, NJ 08805-1258
Office: (732) 764-6969 Ext: 129
Fax:    (732) 764-6755
http://www.linkedin.com/profile

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Keith Ward
DZS Software Solutions
(732) 764-6969 x129
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