Since 1996, ClinPlus® Data Management software (CPDM) and services have helped clients in the pharmaceutical, biotechnology, medical device and contract research industries to manage clinical studies across multiple therapeutic areas and to collect quality data, while meeting strict timelines and staying within budget.
Our latest release of CPDM, Version 3.4, represents a major effort by DZS development, QA and our technical writing staff to improve the system and meet today's technology standards and evolving regulations. Our hard work, expertise and industry experience are evident in this clinical data management software, and we believe it to be the most feature-rich, flexible and intuitive CDMS system ever marketed.
Though CPDM was originally designed to support paper-based trials, many clients are having great success with CPDM for EDC studies as well. Enhancements in Version 3.4 further EDC usability.
ClinPlus Data Management 3.4 integrates directly with our ClinPlus Coding 3.1 software and ClinPlus CTMS to make you even more productive. We have purposely retained the ease-of-use and the low IT support requirements that you have come to expect from ClinPlus. In fact, we believe that CPDM 3.4 is even easier to use.
ClinPlus Data Management (CPDM) is a comprehensive, 21 CFR Part 11 compliant, SAS®-based system specifically designed for managing clinical trial data and projects. The system allows users to easily navigate the ever-changing data collection, analysis, research and evaluation requirements of today's clinical trials. Clinical data management has never been so user-friendly and comprehensive.
From database design, through end-of-study, CPDM provides tools to achieve efficient data processing and high quality clinical data with minimum investment in software installation and setup. The software includes an array of features and functions that facilitate page, record and query tracking, review and cleanup cycles, complete audit trail maintenance, and role-based security.
CPDM can support paper-based and electronic studies, site-based entry, or any combination of the two within the same study. By managing all of your clinical data within one system, you are ensured a smooth progression, from entry of the first casebook, to a clean and secure database lock.
CPDM utilizes the power of Base SAS, enabling you to easily develop unique databases and screens for each study, even if you are not a SAS programmer. Your data is entered into SAS datasets and is instantly accessible for analysis and reporting.
Clinical Study Design
CPDM is flexible enough to build complex data entry systems, as well as simple ones. Range checks for individual variables, intricate cursor movement and pop-up selection lists are among the many features that can be utilized when setting up clinical studies. Structures and screens can be modified in minutes, mid-study, with only a minimum disruption to the data entry process. In cases where protocols are similar, complete studies can be cloned, modeled and adapted quickly to additional protocols. CPDM also supports the creation and maintenance of a library of standard databases and screen designs.
Clinical Data Entry and Verification
With CPDM, you can perform single- or double-key entry. Verification for double-key entry is done concurrently with second key; verification status is maintained at the variable level. Many CPDM features enhance data entry operations in different ways. For example, screens can be presented in any order, second key verification may be skipped for specified fields, and values can be initialized or carried over from screen to screen. These timesaving extras can significantly strengthen the overall performance of your data processing team.
Clinical Data Review and Correction Cycle
Data cleanup does not have to impact a project's momentum, as CPDM supports both manual and computerized review, before, during, or after data entry. You can maintain a library of standard questions to speed Data Resolution Form (DRF) preparation and to promote consistency. Users can customize and generate DRFs for printing, faxing or email, as well as to track each DRF and question. When DRFs are returned, data processing personnel scan or type in a pre-assigned “page key,” which immediately brings up the record for correction, saves the amended record, updates audit trail information, automatically changes the record status, and, if all the questions for that page are resolved, updates the page status. Thus, each correction to the database is made in a single action with a complete audit trail.
CPDM offers superior capabilities for accessing information through all processing phases of your project. CRFs may be tracked individually, at the visit level, or at the casebook level; bar codes may be used to identify pages. CPDM supports batch tracking and provides the ability to have key information embedded in bar codes.
Audit Trail Maintenance
All user functions are logged, including all data entry/initialization actions, changes to verified data, query resolution, security settings, data structure changes and SAS format changes. A variety of reports are at your fingertips that summarize the status and history of each page/record, allowing you to meet all audit trail requirements.
Clinical Study Management
Throughout each study, you'll want to evaluate progress, including the number of pages at each stage of the process, pages and queries that are past due, and personnel performance. CPDM 3.4 now includes a Dashboard that includes key study metrics and an interactive view and access to each patient's casebook, CRF tracking, queries and clinical records
Additionally, You can run pre-defined data integrity checks, adjust security levels and passwords, update data correction codes, and create a wide variety of tracking and performance reports, and customizable data listings. In a single step, CPDM's import utility allows you to import data from other sources, such as labs, fax, OCR and email, and make them system-compatible. The data is always accessible as SAS data sets, from the beginning of entry, to database lock. CPDM is quite simply your complete solution for data management.
The system can be extended to support Electronic Data Capture (EDC) with the use of Citrix.
ClinPlus Data Management requires Base SAS, SAS/AF and SAS/Share software.