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 ClinPlusclients 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 SolutionsSuite 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 SolutionsSuite’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 SystemAdministrative functions.
A collection of system configurationparameters is used to customize thesystem to the unique requirements ofeach company and project. Parametersare first defined at the system level, butcan then be inherited and optionally
overridden at the project level. Thisallows system administrators and projectmanagers to easily enable or disablefeatures and choices that are not requiredfor a specific project. CROs also can assignconfiguration parameters based on thepreferences of their sponsors.
About DZS Software Solutions, Inc.
Technology | Consulting | Outsourcing
ClinPlus is a registered trademark of DZS SoftwareSolutions, Inc. SAS and all other SAS Institute Inc.product or service names are registered trademarksor trademarks of SAS Institute Inc. Microsoft is aregistered trademark of Microsoft Corp. in the U.S.and other countries. Excel is a registered trademarkof 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, decreasecosts, improve safety, and satisfy all applicable regulations.
ClinPlus® Clinical TrialManagement System(CTMS)
• Expedite trial designand study set-up
• Efficiently collect andmanage patient and trialadministration data
• Benefit from secure, stable,and centralized access tosites, trials, and programs
• Reduce trialadministration costs
• Manage the investigatorpayment process
• Remain FDA-compliant
Technology | Consulting | Outsourcing
Reduce staff trainingrequirements.
The ClinPlus CTMS solution requiresminimal user training because of its familiarand intuitive web-based user interface.Screens and menus are laid out in a logicalpattern, with icons and behaviors that arecommon to most current websites.
Perform reporting on trialactivities and gather businessintelligence.
A library of built-in reports and tools allowsauthorized users to access, view, and print
study management data, as well as exportreport data to a variety of other file formats.
Ensure 21CFR Part 11 compliant,role-based security.
ClinPlus CTMS can either maintain its owndatabase of users and passwords orauthenticate users with your organization’sexisting Microsoft Active Directoryplatform. Users are restricted to viewingfeatures or reports based on theirproject-specific role, and can only viewprojects for which they have beengranted access.
7
8
INTEGRATED BLOGS
Integrated Blogs:Blogs (or “Weblogs”) are used to manage andshare communications, issues, or messages toall members of the project team. Blogs areavailable at the Project, Site, and Subject level,and can also include customizable tags foreasy searching and reporting. Team memberscan 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 dataeither manually or electronically
• Lack of visibility to reliable andup-to-date information
• Inability to connect to, communicatewith, and manage trial sites, investigators,and sponsors
• Managing the investigator paymentprocess
• Remaining compliant with FDAguidelines
• Lack of access to archivedregulatory materials, includingSOPs, forms, and study protocols
ClinPlus® Clinical Trial Management System (CTMS)
PROJECT MANAGEMENT OVERVIEW
EXECUTIVE OVERVIEW
Pharmaceutical and biotechnology companiescan spend as many as 15 years and upto $900 million to bring a drug to marketFaced with increased competitive andregulatory pressures, it is clear thatshortening time-to-market for new drugsis more critical than ever.
Two glaring statistics point toa major obstacle in shorteningtime-to-market and lowering cost:
1. Almost half of this cost, or close to$400 million, is accrued during the clinicaltrial phase.
2. Recent studies also indicate that75 percent of all trials conducted in theUnited States are behind schedule by oneto six months.
Most clinical trials involve massivequantities of data, both paper-based andelectronic, from thousands of patients andhundreds of sites – data that must becollected, transmitted, analyzed, and archived.The good news is that companies can reapsignificant cost and time savings with bettermanagement of this clinical trial data.
That is why DZS Software Solutions hasreleased the ClinPlus® Clinical Trial ManagementSystem (CTMS), a flexible and scalableweb-based, .NET-based software solution thatempowers pharmaceutical organizations andcontract research organizations (CROs) tomanage clinical trial operations more produc-tively and efficiently. The ClinPlus® CTMS wasdeveloped on the principle that by improvinguser accessibility and communications,tremendous efficiencies and time savingscould be realized, manual operations couldbe reduced, and redundant data and taskscould be eliminated.
This system was designed specifically to help organizations overcomethe following technical challenges associated with clinical trials:
ClinPlus CTMS: The screens have been designed for easy navigation and consistency throughoutthe system. Easily move between the various areas with a click of the mouse. Most screens presentsummary 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 toadd shortcuts to their most frequently used screens or reports onto the menu bar.
Manage the Investigatorpayment process.
A powerful templating tool allows managersto define budget templates based on user-defined site groups, subject groups, andprotocol amendments. Individual site budgetscan be based on these templates, yet canstill be customized for each investigator.
The ClinPlus CTMS system can then auto-matically calculate payables and paymentamounts for each site based on subjectscreening, enrollment, and visit information.Each payment type can be configuredfor automatic payment, or may call formanagement approval.
6
PROJECT EVENTS
Project Events:Project Events are used to track keymilestones during the course of a clinicalresearch project. Events are customizedfor 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 studiesfaster and more efficiently.
Developed using Microsoft .Nettechnology, ClinPlus CTMS is flexibleenough to handle evolving trialrequirements, yet scalable toaccommodate virtually any sizetrial. It can be rapidly deployedfor new projects using defaultconfiguration variables, and canbe accessed using only a standardweb browser.
Gain on-demand accessto current trial data.
Subject enrollment and visit data can beimported into ClinPlus CTMS from otherelectronic systems, or manually enteredfrom fax enrollment sheets. Centralizedaccess to this clinical trial data deliversgreater data visibility to decision makersacross the organization and allows themto easily identify important issues,productivity bottlenecks, and performanceimprovement opportunities that canoptimize and significantly expedite trials.
SITE EVENTS
1 2
Site Events: Startup Events are used to manage the process of moving a Site through the variousstages from Initial Contact through Site Initiation. Study Events maintain a history of key eventsduring the study.
ClinPlus CTMS is a powerful and intuitive solution that allows you to:
Project Charts:Charts are used to visually demonstratetrends in project data, such as Enrollment,Screening, Site Initiations and Site Visits.Data Import is used to import project datafrom 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 thatis commonly found in individual spread-sheets or documents. A global contactdatabase, shared document repository, andinnovative project blogs enable a level ofinformation sharing that keeps everyone onthe project team working more effectively.Key features will also be available usingpersonal digital assistants (PDAs) foraccess virtually anywhere.
Access to critical trialdocuments.
ClinPlus CTMS provides a central documentrepository for the various protocol-specificdocuments needed by project teammembers. For example, protocols, amend-ments, forms, training materials, regulatorydocuments, and frequently asked questionscan be uploaded to help resolve questionsand streamline many administrative trialtasks. Traveling users can securely accessthese documents without requiringcomplicated VPN technology.
4 5
SITE BUDGET PAYMENTS
Automate clinical trial processes.ClinPlus CTMS performs many routine
trial functions automatically to help improveoverall trial efficiency and reduce trial admini-stration and monitoring costs. Automatednotifications alert managers of key events
or issues, while an integrated task systeminforms each user of their responsibilities.Subject visit schedules are automaticallydefined, milestones are maintained, andenrollment completion projections arecalculated on-the-fly.
MORE FROM CLINPLUS
ClinPlus also offers a completerange of support services to helpyou maximize your softwareinvestment and assure your success.Our dedicated staff average over15 years experience in the clinicaltrials arena, and can provide immediatesupport in the following areas:
• Training
• Hosting
• Study Set-Up
• Screen Design
• ADE/Med Coding
• Template Design
• Table & Listing Design
• CDISC/SDTM/ADaMConversion
• SAS Programming
3
PROJECT PROJECTIONS
Project Projections:The system will use the existing enrollment and site startup data to estimate project enrollmentcompletion 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 foreach trial subject based on user-configurableevents such as screening, enrollment, orsubject visits. Accrued amounts for eachevent may be reduced using adjustmentsfor missing procedures. Events may be setto either automatically pay once the eventis posted, or to first require a manager’sapproval. Payments to investigators may bereduced 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 thatis commonly found in individual spread-sheets or documents. A global contactdatabase, shared document repository, andinnovative project blogs enable a level ofinformation sharing that keeps everyone onthe project team working more effectively.Key features will also be available usingpersonal digital assistants (PDAs) foraccess virtually anywhere.
Access to critical trialdocuments.
ClinPlus CTMS provides a central documentrepository for the various protocol-specificdocuments needed by project teammembers. For example, protocols, amend-ments, forms, training materials, regulatorydocuments, and frequently asked questionscan be uploaded to help resolve questionsand streamline many administrative trialtasks. Traveling users can securely accessthese documents without requiringcomplicated VPN technology.
4 5
SITE BUDGET PAYMENTS
Automate clinical trial processes.ClinPlus CTMS performs many routine
trial functions automatically to help improveoverall trial efficiency and reduce trial admini-stration and monitoring costs. Automatednotifications alert managers of key events
or issues, while an integrated task systeminforms each user of their responsibilities.Subject visit schedules are automaticallydefined, milestones are maintained, andenrollment completion projections arecalculated on-the-fly.
MORE FROM CLINPLUS
ClinPlus also offers a completerange of support services to helpyou maximize your softwareinvestment and assure your success.Our dedicated staff average over15 years experience in the clinicaltrials arena, and can provide immediatesupport in the following areas:
• Training
• Hosting
• Study Set-Up
• Screen Design
• ADE/Med Coding
• Template Design
• Table & Listing Design
• CDISC/SDTM/ADaMConversion
• SAS Programming
3
PROJECT PROJECTIONS
Project Projections:The system will use the existing enrollment and site startup data to estimate project enrollmentcompletion 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 foreach trial subject based on user-configurableevents such as screening, enrollment, orsubject visits. Accrued amounts for eachevent may be reduced using adjustmentsfor missing procedures. Events may be setto either automatically pay once the eventis posted, or to first require a manager’sapproval. Payments to investigators may bereduced by site-specific holdback percentages.
“Sponsors and CROs are expecting the use
of CTMS technology to dramatically improve
efficiencies and data quality.”
Manage the Investigatorpayment process.
A powerful templating tool allows managersto define budget templates based on user-defined site groups, subject groups, andprotocol amendments. Individual site budgetscan be based on these templates, yet canstill be customized for each investigator.
The ClinPlus CTMS system can then auto-matically calculate payables and paymentamounts for each site based on subjectscreening, enrollment, and visit information.Each payment type can be configuredfor automatic payment, or may call formanagement approval.
6
PROJECT EVENTS
Project Events:Project Events are used to track keymilestones during the course of a clinicalresearch project. Events are customizedfor 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 studiesfaster and more efficiently.
Developed using Microsoft .Nettechnology, ClinPlus CTMS is flexibleenough to handle evolving trialrequirements, yet scalable toaccommodate virtually any sizetrial. It can be rapidly deployedfor new projects using defaultconfiguration variables, and canbe accessed using only a standardweb browser.
Gain on-demand accessto current trial data.
Subject enrollment and visit data can beimported into ClinPlus CTMS from otherelectronic systems, or manually enteredfrom fax enrollment sheets. Centralizedaccess to this clinical trial data deliversgreater data visibility to decision makersacross the organization and allows themto easily identify important issues,productivity bottlenecks, and performanceimprovement opportunities that canoptimize and significantly expedite trials.
SITE EVENTS
1 2
Site Events: Startup Events are used to manage the process of moving a Site through the variousstages from Initial Contact through Site Initiation. Study Events maintain a history of key eventsduring the study.
ClinPlus CTMS is a powerful and intuitive solution that allows you to:
Project Charts:Charts are used to visually demonstratetrends in project data, such as Enrollment,Screening, Site Initiations and Site Visits.Data Import is used to import project datafrom other systems, such as EDC or IVRS.
PROJECT CHARTS
Reduce staff trainingrequirements.
The ClinPlus CTMS solution requiresminimal user training because of its familiarand intuitive web-based user interface.Screens and menus are laid out in a logicalpattern, with icons and behaviors that arecommon to most current websites.
Perform reporting on trialactivities and gather businessintelligence.
A library of built-in reports and tools allowsauthorized users to access, view, and print
study management data, as well as exportreport data to a variety of other file formats.
Ensure 21CFR Part 11 compliant,role-based security.
ClinPlus CTMS can either maintain its owndatabase of users and passwords orauthenticate users with your organization’sexisting Microsoft Active Directoryplatform. Users are restricted to viewingfeatures or reports based on theirproject-specific role, and can only viewprojects for which they have beengranted access.
7
8
INTEGRATED BLOGS
Integrated Blogs:Blogs (or “Weblogs”) are used to manage andshare communications, issues, or messages toall members of the project team. Blogs areavailable at the Project, Site, and Subject level,and can also include customizable tags foreasy searching and reporting. Team memberscan 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 dataeither manually or electronically
• Lack of visibility to reliable andup-to-date information
• Inability to connect to, communicatewith, and manage trial sites, investigators,and sponsors
• Managing the investigator paymentprocess
• Remaining compliant with FDAguidelines
• Lack of access to archivedregulatory materials, includingSOPs, forms, and study protocols
ClinPlus® Clinical Trial Management System (CTMS)
PROJECT MANAGEMENT OVERVIEW
EXECUTIVE OVERVIEW
Pharmaceutical and biotechnology companiescan spend as many as 15 years and upto $900 million to bring a drug to marketFaced with increased competitive andregulatory pressures, it is clear thatshortening time-to-market for new drugsis more critical than ever.
Two glaring statistics point toa major obstacle in shorteningtime-to-market and lowering cost:
1. Almost half of this cost, or close to$400 million, is accrued during the clinicaltrial phase.
2. Recent studies also indicate that75 percent of all trials conducted in theUnited States are behind schedule by oneto six months.
Most clinical trials involve massivequantities of data, both paper-based andelectronic, from thousands of patients andhundreds of sites – data that must becollected, transmitted, analyzed, and archived.The good news is that companies can reapsignificant cost and time savings with bettermanagement of this clinical trial data.
That is why DZS Software Solutions hasreleased the ClinPlus® Clinical Trial ManagementSystem (CTMS), a flexible and scalableweb-based, .NET-based software solution thatempowers pharmaceutical organizations andcontract research organizations (CROs) tomanage clinical trial operations more produc-tively and efficiently. The ClinPlus® CTMS wasdeveloped on the principle that by improvinguser accessibility and communications,tremendous efficiencies and time savingscould be realized, manual operations couldbe reduced, and redundant data and taskscould be eliminated.
This system was designed specifically to help organizations overcomethe following technical challenges associated with clinical trials:
ClinPlus CTMS: The screens have been designed for easy navigation and consistency throughoutthe system. Easily move between the various areas with a click of the mouse. Most screens presentsummary 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 toadd 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 ClinPlusclients 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 SolutionsSuite 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 SolutionsSuite’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 SystemAdministrative functions.
A collection of system configurationparameters is used to customize thesystem to the unique requirements ofeach company and project. Parametersare first defined at the system level, butcan then be inherited and optionally
overridden at the project level. Thisallows system administrators and projectmanagers to easily enable or disablefeatures and choices that are not requiredfor a specific project. CROs also can assignconfiguration parameters based on thepreferences of their sponsors.
About DZS Software Solutions, Inc.
Technology | Consulting | Outsourcing
ClinPlus is a registered trademark of DZS SoftwareSolutions, Inc. SAS and all other SAS Institute Inc.product or service names are registered trademarksor trademarks of SAS Institute Inc. Microsoft is aregistered trademark of Microsoft Corp. in the U.S.and other countries. Excel is a registered trademarkof 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, decreasecosts, improve safety, and satisfy all applicable regulations.
ClinPlus® Clinical TrialManagement System(CTMS)
• Expedite trial designand study set-up
• Efficiently collect andmanage patient and trialadministration data
• Benefit from secure, stable,and centralized access tosites, trials, and programs
• Reduce trialadministration costs
• Manage the investigatorpayment process
• Remain FDA-compliant
Technology | Consulting | Outsourcing
