Clinical Reporting Solution™
Meeting 100% of Your Reporting Requirements
Now you can standardize and automate your clinical reporting process and achieve major process improvements:
- Save time
- Reduce operating costs
- Improve reporting quality
- Achieve and maintain regulatory compliance
The Clinical Reporting Solution™ standardizes and automates reporting. Statistical Programmers and Statisticians can quickly and easily generate SAS® programs to produce tables, listings and figures. The DataCeutics’ Clinical Reporting Solution™ has data-driven flexibility and is designed to readily accommodate different data structures, including CDISC standards. Data attributes are not coded in the application; they are collected from the source data or specified by the user.
The Clinical Reporting Solution consists of two components:
- Front-end Report Portal (DRP™)
- Back-end Report Generator (CR Toolkit™)
We have the experience you need to get the results you want since many of our team members have an average of 15 to 20 years in the clinical data environment. >> more
Always looking for the very best talent, we offer an excellent benefits package and many opportunities to advance your skills >> more
We have a unique solution to help you do just that. The Clinical Reporting Toolkit™ (CRToolkit™), a SAS®-based software product, that works as a stand-alone SAS® application or in concert with the DataCeutics Report Portal™, provides you with a better way to create validated tables and listings that are so critical to the regulatory submissions your company has to make.
Create Reports Within Minutes…For a Fraction of the Cost
Without CRToolkit™, a single programmer would likely spend one to two hours just to create a single listing using SAS® System’s programming language. CRToolkit™ cuts that time to 5 minutes. Multiply that by the number of tables and listings your company does in a year, and the benefits are obvious – you could potentially be saving hundreds of thousands of dollars simply by freeing up and reallocating costly programming resources. And since CRToolkit™ speeds the creation of these reports, your company can make regulatory submissions sooner, accelerating the process of getting products on the market.
CRToolkit™ generates 99% of data listings, 80-90% of safety reports, and up to 50% of efficacy reports. As a result, you’ll notice these time- and cost-saving benefits:
Improves productivity by:
- Automating page layout for all output
- Speeding the production of Listings, Tables and Graphics
- Reducing the need for validation
Improves quality by:
- Ensuring consistency and accuracy of reports…regardless of who is running them
- Greatly reducing the lines of SAS® code
- Enforcing one method of report generation…thus reducing programmer style variability
- Reduces cost of generating and validating reports because less programming resources are required.
- Support SAS® ODS, produces output in ASCII, RTF, XML, PDF or HTML formats.
- Allows more timely submissions to regulatory agencies.
- Flexible, easy-to-use, and easy-to-maintain.
Your Reports Will Be Accurate…Every Time
Clean, error-free reports, listings, tables and analyses are critical for successful submission and regulatory approval. A single error can cause weeks of delay. Your company can’t afford to make mistakes. With CRToolkit™, errors in tables and listings are a thing of the past. The software is fully validated, so you can be assured that every report you generate is accurate. And even if programmers change, the results will remain consistent and accurate. Because CRToolkit™ provides you with pre-built report templates, programmers don’t have to write or revise code to create new reports – helping eliminate any chance for errors when programmers change.
- Selecting data files and creating data subsets that can be used in reports
- Building and saving SAS® report programs.
- Executing the SAS® programs to generate reports.
- Viewing and downloading the SAS® source files, log files and report output on the user’s workstation.
- Managing files includes deleting and archiving files, audit trail to track the life of a SAS® program, moving SAS® programs from development to production, modifying report titles and footnotes, viewing and managing subsets, and reviewing the status of a study.
- Automates SAS®-Based Analysis and Reporting.
- Supports a CFR Part 11 compliant SAS® programming environment.
- Uses host-based and application-based security.
- Supports the use of separate development and production areas in the SAS® reporting environment.
- Utilizes the registration of directories to manage study-specific data, program, log and output files.
- Utilizes registration of general and custom SAS® programs manage report generation.
- Can use the CR Toolkit™ reporting software or custom reporting software.
- Generates output in ASCII, HTML, RTF, PDF and XML format.
- Supports the SAS® Output Delivery System (ODS).
- Allows report titles and footnotes to be defaulted and modified.
- Manages report titles and footnotes in a single file for a study.
- Front-end User Interface Software is customizable.
- Fully validated.
- The Listing Generator Template is used to create an ad-hoc listing programs for any domain.
- The Combined Frequency and Descriptive Statistics Template are used to create combined frequency count and descriptive summary table programs using multiple variables from a domain. The template includes p-value generation for common statistical procedures.
- The Subject Frequency Template is used to create subject-level frequency count summary table programs using up to three categorical variables from a domain. The template includes p-value generation for common statistical procedures.
- The Descriptive Statistics Template is used to create a descriptive statistics summary table program using up to two categorical variables, one test variable and a result variable from a domain. The template includes p-value generation for common statistical procedures.
The default Report Templates can be configured by the in-house SAS® programming team to create Build Templates that completely fit your report generation needs. The in-house development team is trained as part of the Clinical Reporting Solution™ Technology Transfer.
OUR COMPREHENSIVE CAPABILITIES INCLUDE:
- SAS® Statistical Programming
- SAS® QC/Verification/Validation
- Protocol Deviation Programming
- SAS® Verification Programming
- Clinical Reporting Tools
- SAS® Systems Development
- Systems Development Life Cycle Methodology
- IEEE Development Methodology
- Standards Implementation
- CDISC CDASH/STDM and ADaM Services
- Electronic Submissions
- Statistical Computing Environment Support
- IT Environment Support
- Clinical Study Report Auditing
- Regulations/GxPs/21 CFR Part 11 Training
- Compliance Assessments
- Vendor Audits
- Business Process Consulting
- SOP Development
- Systems Selection & Implementation
- Test Scripts
- User Acceptance Testing
- Electronic Data Capture (EDC) System Support
- Clinical Programming
- Edit Check Programming
- Data Entry Support
- Clinical Data Management Support
- Medical Writing