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"After reviewing a variety of competitive CTMS systems, DZS's ClinPlus CTMS emerged as the most logical fit for our needs and budget", said Cindy Croissant, PhotoThera's Director of Clinical Operations. "One of the main reasons we decided on DZS, was the fact that we found the intuitive design of the system to be easy to navigate, which we felt eventually would translate into less training time and less potential for errors and frustration among the system users. We were also impressed with the simple elegance of the system, the attention to detail, and DZS's commitment to configure and deliver a product to meet our unique requirements," added Ms. Croissant.

Cindy Croissant

Director of Clinical Operations-PhotoThera

CTMS Software as a Service (SaaS)

CTMS Features

ClinPlus CTMS includes all of the key features you would expect in an enterprise CTMS solution, such as:

Project Management and Enrollment Projections
Project and Regulatory Document Storage
Global Contact and Central Investigator Database
Centralized Project Communications
Enrollment and Subject Visit Tracking
Investigator Budgets and Subject Payments
Data Import and Export Utilities
Companies can track and obtain reports on every aspect of day-to-day trial management. This enhances operational and project management control. Moreover, the CTMS allows managers to deploy monitoring resources in the most appropriate manner to address a particular issue.
Delivers relevant information to study stakeholders as rapidly as possible. Helps to manage the relationship between CRO and Sponsor as well as enhancing operational control of individual studies and the entire program.
Helps sponsors promote operational and workflow standards.
Standardizes processes across all project teams and increases efficiency, by sharing common data across clinical studies.
Ensures timely investigator payments and allow accurate financial reporting. Timely payments help maintain investigators' interest in and commitment to the study.

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ClinPlus Clinical Trial Management System (CTMS)

EXECUTIVE OVERVIEW

The Current Situation - Pharmhaceutical, biotechnology and medical device companies can spend as many as 15 years and up to $900 million to bring a single drug to market. Faced with increased competitive and regulatory pressures, it is clear that shortening time-to-market for new drugs is more critical than ever.

The ClinPlus Clinical Trial Management System (CTMS) helps improve trial management processes and better manage costs. Cost management is a particular priority for pharmaceutical and biotechnology companies aiming to maximise their return on investment or minimise the financial burn. It is estimated that keeping a trial running costs around US$40,000 per day. The impact on lost sales revenue is even more marked: every extra day that a drug remains in clinical studies costs the sponsor at least US$600,000 in lost sales. Apart from making it easier for sponsors to attain key clinical trial milestones and helping to control costs, CTMS also offers intangible benefits, such as improved regulatory compliance, reduced complexity, superior information flow and enhanced relationships with clinical investigators.

The Challenge for Sponsors and CRO's - Almost half of this cost, or close to $400 million, is accrued during the clinical trial phase, where patient data must be efficiently collected, transmitted, analyzed, archived and auditable. In response to these clients needs, DZS Software Solutions developed the ClinPlus® Clinical Trial Management System (CTMS), a flexible and scalable web-based, .NET-based software solution that empowers pharmaceutical, biotechnology and device organizations and contract research organizations (CROs) the ability to manage and collaborate on their clinical trial operations more productively and efficiently.

ClinPlus knows what you need - The ClinPlus®CTMS was developed on the underlying principle that by improving user accessibility and communications, tremendous efficiencies and time savings could be realized, many manual operations could be reduced or eliminated, and redundant data and efforts could be eliminated.

How our CTMS is different - While many software organizations have introduced CTMS solutions, very few have proven to be intuitive and straightforward enough to achieve rapid deployment and training across an organization, and can often fail at reducing time-to-market. Even fewer CTMS solutions provide the flexible tools to easily configure the system to meet a variety of user needs, provide on-the-fly visibility to critical trial data and operations milestones to satisfactorily meet the changing trial demands of CRO's and Sponsors.

ClinPlus developer Steve Trigilio

ClinPlus CTMS design and development has been led by Steve Trigilio, a leader in CTMS design technology. Steve has been developing CTMS and Data Management applications since the early 1990s, following a long history of Clinical Research roles. From Research Lab Manager to CRA, Project Manager, and Data Manager, Steve has the experience required to fully understand all aspects of a well-designed and easy-to-use CTMS. Steve was most recently the Chief Technology Officer at a CRO, and has been recognized as a Microsoft Certified Solutions Developer for .Net Applications.

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Value of ClinPlus CTMS:

Expedites clinical trial design and clinical study set-up
Efficiently collects and manages patient and trial administration data
Users benefit from a secure, stable, and centralized access to multiple sites, trials, and programs
Dramatically reduces trial administration costs
Manages the investigator/patient payment process
Helps Sponsors to Remain FDA-compliant

The ClinPlusCTMS can be configured to track, measure and report on virtually every aspect of a clinical trial or study program. The relational database at the heart of the CTMS groups, analyses and filters clinical trial operations information at various levels including, among others, trial, country, site, investigator, product, clinical research associate (CRA) etc. As a result, ClinPlusCTMS provides a view of trial management data suited to a variety of individuals within the organization, including high-level, consolidated metrics for senior managers. The ClinPlusCTMS allows managers to view the progress of multiple studies and compare protocols in order to optimize future studies. Financial managers can view the total costs and expenditures across clinical programs. The ClinPlusCTMS can also provide detailed reports allowing, for example, a project manager to view enrolment figures for a specific site or investigator and assess the performance of the study recruitment strategy to respond in a timely manner by opening new study sites or taking other actions to ensure target timelines can be met.