DZS Software Solutions, Inc. announces the next generation of the ClinPlus Data Management software (CPDM 3.0). This release represents a 2+ year effort by the DZS development, QA and technical writing staff to completely reengineer the ClinPlus Data Management system to meet today’s technology standards and regulations. Our hard work, expertise, and industry experience are evident in this system that we believe to be the most feature-rich, flexible, and intuitive CDMS system ever to be marketed. We are very proud to be able to provide this system to our clients and to offer it to the pharmaceutical industry.

While many new features have been added, we have retained the ease-of-use and the low IT support requirements you have come to expect with our current system. In fact, we believe CPDM 3.0 to be even easier to use. Some highlights include:

User Friendly Look and Feel A significant amount of effort has gone into aesthetics and consistent, intelligent navigation.

Security This system includes role based security. Data access control down to the variable level. Separate system logon with a time-out feature. Full read, write, and alter password protection. All implemented with 21 CFR Part 11 in mind.

Data Structures Follow a Relational Model This means increased efficiency, decreased redundancy, and easier access of data, while maintaining integrity. Data libraries have been segregated by type. For instance, clinical data, system data, data entry screens, etc. reside in separate subdirectories. Users access system and clinical data through the use of views, which are also stored in their own libraries.

Data Entry Screens The data entry screens use dynamic frames, our own technology allowing screens to be built using common objects like drop down lists, radio boxes, check boxes, list boxes and, of course, text entry boxes. Screens may also include images making it possible to scan a CRF and overlay your entry fields on the image to produce a data entry screen that is identical to your paper CRF. You can add custom controls and functionality by adding push buttons or icons. An example would be to create a link to custom help for the current screen.

Full Linking to Pertinent Information from Data Entry Screens Audit trail records, outstanding queries, and comments for the displayed record are a click away. New queries (pending issues) may be added from the data entry screens. This is analogous to placing a sticky note on your CRF. Data may also be displayed and selected in list format.

Imaging Support Studies may be set up to do side-by-side data entry from CRF images. Images are scanned, faxed, or provided through third party software, such as Teleforms, then displayed during data entry.

Comprehensive Audit Trails Every addition, change, and deletion of all clinical and system data is logged in audit trails. You have the option to turn on SAS’s audit trail in addition to the ClinPlus audit trails.

Global Variable Libraries Store variable attributes including name, type, format, informat, label, minimum, maximum, and valid values that will support standards and aid in structure design and validation.

Global Investigators Libraries Store Investigator’s names, addresses, and contact information.

Data Resolution Management CPDM 3.0 allows users to define query work flows through the use of levels. For instance, you may assign a level of “Pending DM review” to a query (issue) surfaced at data entry. The Data Manager can periodically subset and review all queries pending their review and either resolve them, promote them to another level, or generate an outstanding query. Printed queries (DRFs) are saved and easily accessed for review or reprinting. Custom DRF templates can be designed without programming. Links between resolved queries and changes to the clinical data are captured in the audit trail through a query id number allowing you the ability to track and monitor the query resolution process.

CRF Tracking Features have been added to speed the CRF tracking process such as page orders (pages increment automatically), range tracking (groups of pages can be tracked at once), and auto adding (no need to press enter after scanning).

Programmatic Data Verification Enhanced control over processing includes better sub setting, duplicate query control, program management, error handling, and job history.

CDISC CDISC import and export capabilities have been added (Operational Data Model).

SAS Import/Export Templates Export templates provide the ability to restructure data during an export. This will allow our CRO clients to maintain their own standards and deliver data as required by their clients. SAS transport files may also be generated. Import templates allow restructuring during import.

SAS/SHARE CPDM 3.0 optionally supports SAS/SHARE. SAS/SHARE’s client server technology allows multi-user access across different hardware environments. CPDM 3.0 supports multi-user access and record level locking without SAS/SHARE, however, it is recommended.
See SAS/SHARE for additional information.

Custom Reports CPDM 3.0 includes a variety of “canned” reports and allows users to access the report source code, modify it, and add it to the system as a custom report. Users may also write and add reports from scratch. Since all report modules reside in a separate catalog, we will be able to supply additional reports without having to issue a new version of the system.

Online Help The comprehensive online help system written using RoboHelp, an industry standard, includes hyperlinks, a full index, and search capabilities.

21 CFR Part 11 Compliance See Data Management Compliance Grid