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DZS Software Solutions, Inc. (www.clinplus.com) 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. Presently, over 50 clients globally 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 produc- tivity and maximized the value of clinical research investments and gained a com- petitive 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, 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 all. Manage System Administrative functions. A collection of system configuration parameters is used to customize the system to the unique requirements of each company and project. Parameters are first defined at the system level, but can then be inherited and optionally overridden at the project level. This allows system administrators and project managers to easily enable or disable features and choices that are not required for a specific project. CROs also can assign configuration parameters based on the preferences of their sponsors. About DZS Software Solutions, Inc. Technology | Consulting | Outsourcing ClinPlus is a registered trademark of DZS Software Solutions, Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. Microsoft is a registered trademark of Microsoft Corp. in the U.S. and other countries. Excel is a registered trademark of Microsoft Corp. in the U.S. and other countries. ® indicates USA registration. DZS Software Solutions, Inc. +1 732.764.6969 For more information, please visit: www.clinplus.com ClinPlus® CTMS 10 Regardless of the size, scope or status of your study, ClinPlus CTMS will improve productivity, decrease costs, improve safety, and satisfy all applicable regulations. ClinPlus® Clinical Trial Management System (CTMS) • Expedite trial design and study set-up • Efficiently collect and manage patient and trial administration data • Benefit from secure, stable, and centralized access to sites, trials, and programs • Reduce trial administration costs • Manage the investigator payment process • Remain FDA-compliant Technology | Consulting | Outsourcing Reduce staff training requirements. The ClinPlus CTMS solution requires minimal user training because of its familiar and intuitive web-based user interface. Screens and menus are laid out in a logical pattern, with icons and behaviors that are common to most current websites. Perform reporting on trial activities and gather business intelligence. A library of built-in reports and tools allows authorized users to access, view, and print study management data, as well as export report data to a variety of other file formats. Ensure 21CFR Part 11 compliant, role-based security. ClinPlus CTMS can either maintain its own database of users and passwords or authenticate users with your organization’s existing Microsoft Active Directory platform. Users are restricted to viewing features or reports based on their project-specific role, and can only view projects for which they have been granted access. 7 8 INTEGRATED BLOGS Integrated Blogs: Blogs (or “Weblogs”) are used to manage and share communications, issues, or messages to all members of the project team. Blogs are available at the Project, Site, and Subject level, and can also include customizable tags for easy searching and reporting. Team members can add comments to each blog entry. “Organizations are increasingly turning to clinical trial management systems (CTMS) to improve trial efficiencies, cut trial costs, and enhance the productivity of trial participants..” 9 • Complex and time-consuming trial design, planning, and training • Inefficiencies in capturing patient data either manually or electronically • Lack of visibility to reliable and up-to-date information • Inability to connect to, communicate with, and manage trial sites, investigators, and sponsors • Managing the investigator payment process • Remaining compliant with FDA guidelines • Lack of access to archived regulatory materials, including SOPs, forms, and study protocols ClinPlus® Clinical Trial Management System (CTMS) PROJECT MANAGEMENT OVERVIEW EXECUTIVE OVERVIEW Pharmaceutical and biotechnology companies can spend as many as 15 years and up to $900 million to bring a 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. Two glaring statistics point to a major obstacle in shortening time-to-market and lowering cost: 1. Almost half of this cost, or close to $400 million, is accrued during the clinical trial phase. 2. Recent studies also indicate that 75 percent of all trials conducted in the United States are behind schedule by one to six months. Most clinical trials involve massive quantities of data, both paper-based and electronic, from thousands of patients and hundreds of sites – data that must be collected, transmitted, analyzed, and archived. The good news is that companies can reap significant cost and time savings with better management of this clinical trial data. That is why DZS Software Solutions has released the ClinPlus® Clinical Trial Management System (CTMS), a flexible and scalable web-based, .NET-based software solution that empowers pharmaceutical organizations and contract research organizations (CROs) to manage clinical trial operations more produc- tively and efficiently. The ClinPlus® CTMS was developed on the principle that by improving user accessibility and communications, tremendous efficiencies and time savings could be realized, manual operations could be reduced, and redundant data and tasks could be eliminated. This system was designed specifically to help organizations overcome the following technical challenges associated with clinical trials: ClinPlus CTMS: The screens have been designed for easy navigation and consistency throughout the system. Easily move between the various areas with a click of the mouse. Most screens present summary information first, and allow the user to drill down for more detail. Access to projects, sites, menus and features is restricted using role-based security. The “My Favorites” feature allows users to add shortcuts to their most frequently used screens or reports onto the menu bar. Manage the Investigator payment process. A powerful templating tool allows managers to define budget templates based on user- defined site groups, subject groups, and protocol amendments. Individual site budgets can be based on these templates, yet can still be customized for each investigator. The ClinPlus CTMS system can then auto- matically calculate payables and payment amounts for each site based on subject screening, enrollment, and visit information. Each payment type can be configured for automatic payment, or may call for management approval. 6 PROJECT EVENTS Project Events: Project Events are used to track key milestones during the course of a clinical research project. Events are customized for each project. “Existing generic competition, the impending loss of major patents and a relatively thin pipeline will all apply substantial pressure to the branded pharmaceutical industries, because of the nature of the clinical trials industry, it will, in turn be under increasing pressure.” Deploy clinical trial studies faster and more efficiently. Developed using Microsoft .Net technology, ClinPlus CTMS is flexible enough to handle evolving trial requirements, yet scalable to accommodate virtually any size trial. It can be rapidly deployed for new projects using default configuration variables, and can be accessed using only a standard web browser. Gain on-demand access to current trial data. Subject enrollment and visit data can be imported into ClinPlus CTMS from other electronic systems, or manually entered from fax enrollment sheets. Centralized access to this clinical trial data delivers greater data visibility to decision makers across the organization and allows them to easily identify important issues, productivity bottlenecks, and performance improvement opportunities that can optimize and significantly expedite trials. SITE EVENTS 1 2 Site Events: Startup Events are used to manage the process of moving a Site through the various stages from Initial Contact through Site Initiation. Study Events maintain a history of key events during the study. ClinPlus CTMS is a powerful and intuitive solution that allows you to: Project Charts: Charts are used to visually demonstrate trends in project data, such as Enrollment, Screening, Site Initiations and Site Visits. Data Import is used to import project data from other systems, such as EDC or IVRS. PROJECT CHARTS Facilitate team interaction. Users have access to shared data with ClinPlus CTMS, eliminating redundant, non-secure, and outdated information that is commonly found in individual spread- sheets or documents. A global contact database, shared document repository, and innovative project blogs enable a level of information sharing that keeps everyone on the project team working more effectively. Key features will also be available using personal digital assistants (PDAs) for access virtually anywhere. Access to critical trial documents. ClinPlus CTMS provides a central document repository for the various protocol-specific documents needed by project team members. For example, protocols, amend- ments, forms, training materials, regulatory documents, and frequently asked questions can be uploaded to help resolve questions and streamline many administrative trial tasks. Traveling users can securely access these documents without requiring complicated VPN technology. 4 5 SITE BUDGET PAYMENTS Automate clinical trial processes. ClinPlus CTMS performs many routine trial functions automatically to help improve overall trial efficiency and reduce trial admini- stration and monitoring costs. Automated notifications alert managers of key events or issues, while an integrated task system informs each user of their responsibilities. Subject visit schedules are automatically defined, milestones are maintained, and enrollment completion projections are calculated on-the-fly. MORE FROM CLINPLUS ClinPlus also offers a complete range of support services to help you maximize your software investment and assure your success. Our dedicated staff average over 15 years experience in the clinical trials arena, and can provide immediate support in the following areas: • Training • Hosting • Study Set-Up • Screen Design • ADE/Med Coding • Template Design • Table & Listing Design • CDISC/SDTM/ADaM Conversion • SAS Programming 3 PROJECT PROJECTIONS Project Projections: The system will use the existing enrollment and site startup data to estimate project enrollment completion dates. In this example, the rate of enrollment would have to almost double (from 0.50 to 0.92 subjects/site month) in order to achieve an on-time completion. Site Budget Payments: CTMS calculates payment amounts for each trial subject based on user-configurable events such as screening, enrollment, or subject visits. Accrued amounts for each event may be reduced using adjustments for missing procedures. Events may be set to either automatically pay once the event is posted, or to first require a manager’s approval. Payments to investigators may be reduced by site-specific holdback percentages. “Sponsors and CROs are expecting the use of CTMS technology to dramatically improve efficiencies and data quality.” Facilitate team interaction. Users have access to shared data with ClinPlus CTMS, eliminating redundant, non-secure, and outdated information that is commonly found in individual spread- sheets or documents. A global contact database, shared document repository, and innovative project blogs enable a level of information sharing that keeps everyone on the project team working more effectively. Key features will also be available using personal digital assistants (PDAs) for access virtually anywhere. Access to critical trial documents. ClinPlus CTMS provides a central document repository for the various protocol-specific documents needed by project team members. For example, protocols, amend- ments, forms, training materials, regulatory documents, and frequently asked questions can be uploaded to help resolve questions and streamline many administrative trial tasks. Traveling users can securely access these documents without requiring complicated VPN technology. 4 5 SITE BUDGET PAYMENTS Automate clinical trial processes. ClinPlus CTMS performs many routine trial functions automatically to help improve overall trial efficiency and reduce trial admini- stration and monitoring costs. Automated notifications alert managers of key events or issues, while an integrated task system informs each user of their responsibilities. Subject visit schedules are automatically defined, milestones are maintained, and enrollment completion projections are calculated on-the-fly. MORE FROM CLINPLUS ClinPlus also offers a complete range of support services to help you maximize your software investment and assure your success. Our dedicated staff average over 15 years experience in the clinical trials arena, and can provide immediate support in the following areas: • Training • Hosting • Study Set-Up • Screen Design • ADE/Med Coding • Template Design • Table & Listing Design • CDISC/SDTM/ADaM Conversion • SAS Programming 3 PROJECT PROJECTIONS Project Projections: The system will use the existing enrollment and site startup data to estimate project enrollment completion dates. In this example, the rate of enrollment would have to almost double (from 0.50 to 0.92 subjects/site month) in order to achieve an on-time completion. Site Budget Payments: CTMS calculates payment amounts for each trial subject based on user-configurable events such as screening, enrollment, or subject visits. Accrued amounts for each event may be reduced using adjustments for missing procedures. Events may be set to either automatically pay once the event is posted, or to first require a manager’s approval. Payments to investigators may be reduced by site-specific holdback percentages. “Sponsors and CROs are expecting the use of CTMS technology to dramatically improve efficiencies and data quality.” Manage the Investigator payment process. A powerful templating tool allows managers to define budget templates based on user- defined site groups, subject groups, and protocol amendments. Individual site budgets can be based on these templates, yet can still be customized for each investigator. The ClinPlus CTMS system can then auto- matically calculate payables and payment amounts for each site based on subject screening, enrollment, and visit information. Each payment type can be configured for automatic payment, or may call for management approval. 6 PROJECT EVENTS Project Events: Project Events are used to track key milestones during the course of a clinical research project. Events are customized for each project. “Existing generic competition, the impending loss of major patents and a relatively thin pipeline will all apply substantial pressure to the branded pharmaceutical industries, because of the nature of the clinical trials industry, it will, in turn be under increasing pressure.” Deploy clinical trial studies faster and more efficiently. Developed using Microsoft .Net technology, ClinPlus CTMS is flexible enough to handle evolving trial requirements, yet scalable to accommodate virtually any size trial. It can be rapidly deployed for new projects using default configuration variables, and can be accessed using only a standard web browser. Gain on-demand access to current trial data. Subject enrollment and visit data can be imported into ClinPlus CTMS from other electronic systems, or manually entered from fax enrollment sheets. Centralized access to this clinical trial data delivers greater data visibility to decision makers across the organization and allows them to easily identify important issues, productivity bottlenecks, and performance improvement opportunities that can optimize and significantly expedite trials. SITE EVENTS 1 2 Site Events: Startup Events are used to manage the process of moving a Site through the various stages from Initial Contact through Site Initiation. Study Events maintain a history of key events during the study. ClinPlus CTMS is a powerful and intuitive solution that allows you to: Project Charts: Charts are used to visually demonstrate trends in project data, such as Enrollment, Screening, Site Initiations and Site Visits. Data Import is used to import project data from other systems, such as EDC or IVRS. PROJECT CHARTS Reduce staff training requirements. The ClinPlus CTMS solution requires minimal user training because of its familiar and intuitive web-based user interface. Screens and menus are laid out in a logical pattern, with icons and behaviors that are common to most current websites. Perform reporting on trial activities and gather business intelligence. A library of built-in reports and tools allows authorized users to access, view, and print study management data, as well as export report data to a variety of other file formats. Ensure 21CFR Part 11 compliant, role-based security. ClinPlus CTMS can either maintain its own database of users and passwords or authenticate users with your organization’s existing Microsoft Active Directory platform. Users are restricted to viewing features or reports based on their project-specific role, and can only view projects for which they have been granted access. 7 8 INTEGRATED BLOGS Integrated Blogs: Blogs (or “Weblogs”) are used to manage and share communications, issues, or messages to all members of the project team. Blogs are available at the Project, Site, and Subject level, and can also include customizable tags for easy searching and reporting. Team members can add comments to each blog entry. “Organizations are increasingly turning to clinical trial management systems (CTMS) to improve trial efficiencies, cut trial costs, and enhance the productivity of trial participants..” 9 • Complex and time-consuming trial design, planning, and training • Inefficiencies in capturing patient data either manually or electronically • Lack of visibility to reliable and up-to-date information • Inability to connect to, communicate with, and manage trial sites, investigators, and sponsors • Managing the investigator payment process • Remaining compliant with FDA guidelines • Lack of access to archived regulatory materials, including SOPs, forms, and study protocols ClinPlus® Clinical Trial Management System (CTMS) PROJECT MANAGEMENT OVERVIEW EXECUTIVE OVERVIEW Pharmaceutical and biotechnology companies can spend as many as 15 years and up to $900 million to bring a 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. Two glaring statistics point to a major obstacle in shortening time-to-market and lowering cost: 1. Almost half of this cost, or close to $400 million, is accrued during the clinical trial phase. 2. Recent studies also indicate that 75 percent of all trials conducted in the United States are behind schedule by one to six months. Most clinical trials involve massive quantities of data, both paper-based and electronic, from thousands of patients and hundreds of sites – data that must be collected, transmitted, analyzed, and archived. The good news is that companies can reap significant cost and time savings with better management of this clinical trial data. That is why DZS Software Solutions has released the ClinPlus® Clinical Trial Management System (CTMS), a flexible and scalable web-based, .NET-based software solution that empowers pharmaceutical organizations and contract research organizations (CROs) to manage clinical trial operations more produc- tively and efficiently. The ClinPlus® CTMS was developed on the principle that by improving user accessibility and communications, tremendous efficiencies and time savings could be realized, manual operations could be reduced, and redundant data and tasks could be eliminated. This system was designed specifically to help organizations overcome the following technical challenges associated with clinical trials: ClinPlus CTMS: The screens have been designed for easy navigation and consistency throughout the system. Easily move between the various areas with a click of the mouse. Most screens present summary information first, and allow the user to drill down for more detail. Access to projects, sites, menus and features is restricted using role-based security. The “My Favorites” feature allows users to add shortcuts to their most frequently used screens or reports onto the menu bar. DZS Software Solutions, Inc. (www.clinplus.com) 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. Presently, over 50 clients globally 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 produc- tivity and maximized the value of clinical research investments and gained a com- petitive 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, 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 all. Manage System Administrative functions. A collection of system configuration parameters is used to customize the system to the unique requirements of each company and project. Parameters are first defined at the system level, but can then be inherited and optionally overridden at the project level. This allows system administrators and project managers to easily enable or disable features and choices that are not required for a specific project. CROs also can assign configuration parameters based on the preferences of their sponsors. About DZS Software Solutions, Inc. Technology | Consulting | Outsourcing ClinPlus is a registered trademark of DZS Software Solutions, Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. Microsoft is a registered trademark of Microsoft Corp. in the U.S. and other countries. Excel is a registered trademark of Microsoft Corp. in the U.S. and other countries. ® indicates USA registration. DZS Software Solutions, Inc. +1 732.764.6969 For more information, please visit: www.clinplus.com ClinPlus® CTMS 10 Regardless of the size, scope or status of your study, ClinPlus CTMS will improve productivity, decrease costs, improve safety, and satisfy all applicable regulations. ClinPlus® Clinical Trial Management System (CTMS) • Expedite trial design and study set-up • Efficiently collect and manage patient and trial administration data • Benefit from secure, stable, and centralized access to sites, trials, and programs • Reduce trial administration costs • Manage the investigator payment process • Remain FDA-compliant Technology | Consulting | Outsourcing
