This comprehensive SAS-based system is ideal for authoring safety and efficacy tables and listings as well as other tables and listings including patient profiles. A new Report Template library containing over 60+ commonly used tables can significantly increase programmer productivity when developing custom tables. The system requires SAS Base and SAS Stat software to operate.
DZS is a licensed reseller of SAS and can often provide discounted pricing.
EXECUTIVE OVERVIEW
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A major goal of biostatisticians and clinical data managers throughout the industry is to implement consistent internal processes to monitor and maintain data management compliance.
At the same time, along with medical writers and programmers, they must produce accurate and consistent statistical tables and listings to present the data and their findings. Because they operate in a highly demanding and ever-changing environment, they must accomplish these goals while struggling with the ambiguities of current regulations.
With the Clinical Data Interchange Standards Consortium (CDISC) setting out additional standards - the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) - the situation becomes ever more daunting. However, adhering to and properly managing these data standards among workgroups, between departments and across the enterprise, can result in dramatic time-savings, increased productivity and earlier visibility to reliable clinical data. |
DZS Software Solutions ClinPlus® Report has emerged as the industry's most widely-proven, SAS®-based, statistical table and listing authoring tool for creating the highest quality statistical tables and listings from any type of clinical data.
With unmatched versatility ClinPlus Report can create simple data listings as well as complex statistical summary tables. In fact, because of it's unmatched ability to control the look and feel of how data and tables are formatted, it has been adopted by over 50 organizations, including most of the top tier pharmaceutical companies worldwide.
Our latest enhancement to the software, the ClinPlus ADaM Data Conversion Toolkit and Template Library, is the most powerful solution for generating safety tables and listings and providing the supporting documentation in a validated, standardized CDISC/ADaM compliant manner.
Customize tables and listings to suit your needs or the Sponsor's!
ClinPlus Report has many features that address the complex requirements of clinical reporting. Below are just some of the options that allow you to control the look of your tables and listings:
- Inclusion/exclusion of columns, not present in the data
- Joining of categorical and continuous statistics within a single cell
- Decimal point alignment
- Text-wrapping on word boundaries
- Variable stacking within a column
- Multiple justification within a single title/footnote line
- Flexible page-numbering (n of tot, n (Last), etc.)
- Conditional footnotes
- Extensive page-handling intelligence and much more!
The system has three major components:
The Report Engine,
The foundation of the system, the Report Engine has been used by pharmaceutical companies in the U.S. and internationally since 1989.The Report Engine doesn't rely on canned procedures such as Proc Report, Proc Tabulate or Proc Print, for report presentation, thus eliminating many of the inherent limitations in those SAS procedures, but still retaining complete reusability.
The Report GUI (Graphical User Interface)
The Report GUI provides point-and-click access to the Report Engine. This eliminates syntax errors and extends the system to a wider range of users. It allows you to create and manage pure metadata templates that can be recalled, modified and used to create stand-alone SAS programs.
Other features, like a global titles and footnotes library and format builder, are also included. Many leading pharmaceutical companies are leveraging this capability in a post-marketing and epidemiologic capacity to provide insight into drug safety and efficacy trends, and to track unusual values and other relationships within extremely large patient data populations.
The RTF Engine
The RTF Engine is used to generate true RTF (Rich Text Format) tables for your final report without any modification allowing it to be easily utilized in most Microsoft Office applications. This proprietary engine which does not rely on SAS's ODS, was designed with the complex formatting demands of medical writers, and biostatisticians in mind. A single RTF style sheet may be used for all of your data-based presentations.
QC and Third-Party Execution
ClinPlus Report produces a separate executable SAS program containing only the SAS procedure code that was used when the table was created. When executed, it produces raw procedure output showing your calculations as they appear in your table. This is generally used for QC purposes or as back up documentation. All ClinPlus Report programs are stand-alone SAS programs, and may be delivered to a third-party along with the Report Engine macro catalog for execution.
ClinPlus Report allows you to easily produce a variety of complex FDA-ready tables and listings in New Drug Application (NDA) quality. It also produces effective statistical tables, and utilizes over 70 different statistical values across numerous SAS/STAT procedures. You can choose precision, group and class variables, sub-setting, or subtotals, and you always have the final word in controlling the appearance of the table. ClinPlus Report's extensive format control features are a tremendous asset when preparing any summary you require and producing tables and listings in any format you need.
Standardize the appearance of your data
RTF (rich text format) is produced directly from ClinPlus Report for inclusion in word processing programs as native tables. By creating RTF style sheets, you can control the font, point size, color, shading, border styles, etc., and eliminate the need to reformat your tables in a final report.
Titles and footnotes can appear in table cells and may contain RTF tags for the Table of Contents (TOC) or in-line style changes such as single word bolding. Automatic bolding of significant p-values, separate style for group headings and fine tuning, down to 1/100th on an inch for title and footnote alignment, are just a few features that set this system apart.
Gain unrivaled flexibility with CDISC standardization
Other systems for report generation rely on a library of pre-designed templates and require that your data structures conform to their templates or additional programming is required. ClinPlus Report is designed with a different philosophy... to be a true data-driven report authoring tool that can produce an endless variety of reports, using any data structure, including the CDISC SDTM standard. Users need only specify the location of the datasets, the views and the formats. In fact, ClinPlus Report is so flexible you can use it for marketing, financial or any other type of data analysis.
Streamline table and listing production without sacrificing quality
Generating tables and listings can be a costly and an extremely time-consuming undertaking, especially when you consider the salary of an advanced SAS programmer. ClinPlus Report streamlines your process by enabling a broad range of users, often working in desparate locations to produce identically formatted tables and listings without knowing the SAS programming language. Our point-and-click user interface makes it easy to operate and learn, and provides immediate access to your data, thereby significantly reducing the time it takes to create a new table or listing.
Create Customized Patient Profile Listings
ClinPlus Report has additional application within pharmaceutical, biotech, medical device or contract research organizations by supporting the Data Management QC requirements to produce random sample, patient profiles in a clearly formatted summary prior to database lock to ascertain accuracy.
Converting SDTM to ADaM Using the ClinPlus ADaM Data Conversion Toolkit and Template Library
Adhering to CDISC standards has proven to facilitate efficient data integration and transport as well as access and review. Ideally, the FDA will want to perform analytic review using Analysis Data Model (ADaM) standards.
Converting your SDTM data to ADaM data, and then to submission-ready tables, as well as accurately documenting the process, can present numerous challenges. One of the primary challenges is providing reviewers with complete documentation and clear descriptions of the usage, structure, contents and attributes of all the submitted datasets and variables. A second challenge when creating tables and listings is to provide a traceability as to how the ADaM datasets were derived or calculated. The process tracks each variable in the ADaM dataset back to its original source.
CDISC specifications also indicate that any variables copied or derived from an SDTM domain into an ADaM dataset must retain the integrity of the data in the SDTM domain. This allows reviewers to replicate most analyses, tables, graphs and listings with minimal or no transformation and enable them to easily view and subset the data used to generate any analyses, tables, graphs or listings without complex programming.
The final challenge is to produce and present "in-text tables and data listings" in a highly readable manner with consistent formatting from table-to-table and studyto-study. To answer these challenges, DZS Software Solutions has enhanced ClinPus Report with the ClinPlus ADaM Data Conversion ToolKit and Template Library. This enhancement responds to the needs for both metadata-driven conversion of SDTM data to ADaM data and flexible production of metadata-driven safety tables and listings from the ADaM data.
A complete library of more than 60+ "commonly-used" templates is provided and are totally customizable for any other table needs.
Let us help!
DZS's professional staff of statistical programmers and trainers can assist your organization with consulting services, set-up of your standard template libraries, on-site training, the construction of new, custom templates, and final validation of your system.
Our programmers have an average of 15 years of SAS programming experience in the pharmaceutical industry and are expert ClinPlus Report users. In addition to successfully supporting global implementations of ClinPlus Report for several Tier 1 pharmaceutical manufacturers, we provide world-class customer care to all of our clients in organizations of all sizes.
Flexible Delivery Methods
ClinPlus Report can be easily implemented by DZS experts to get you up and running quickly, whether you decide to purchase the software, lease it or have DZS do the work for you. We also provide complete validation scripts or we can perform the validation for you!
Your decision is easy!
ClinPlus Report is quite simply the most flexible and powerful statistical table and listing production system available in the industry today. Your organization will realize dramatic cost-savings benefits in T&L development, Quality Control and final report assembly time.
Reports generated with ClinPlus Report promise to be consistent, of superior quality and based on your standards, even across disparate programming groups. And you will benefit from the peace-of-mind that comes in knowing the reports you deliver are produced using a validated product and are totally CDISC-compliant when included in your eventual NDA, eCTD, NeeS marketing authorization applications. To see for yourself why so many major pharmaceutical companies, biotechs, medical device manufacturers and CROs have adopted ClinPlus Report as their standard, contact us for a personal demo today!