Clinical Reporting Solution™
|
| Download PDF
Overview |
| 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
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| The Clinical Reporting Solution™ standardizes and automates reporting-Statistical Programmers and Statisticians can quickly and easily build, view, run and store SAS® programs and produce pre-specified standard tables, listings and graphs and nonstandard TLGs. |
| DataCeutics' Clinical Reporting Solution™ has data-driven flexibility and is designed to readily accommodate different data structures, including CDISC SDS standards. Data attributes are not coded in the application, but are specified by the system user. Output can be produced in ASCII, PDF, RTF, HTML, XML and Graphics format. |
| The Clinical Reporting
Solution™ is a complete reporting system
consisting of two components: |
- Front-end Report Portal (DRP™)
- Back-end Report Generator (CR Toolkit™)
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| Front-end Report Portal
(DRP™) |
The
thin-client, server-based, HTML and SAS application provides users with an
easy to use
front end. Users log in, select a project and a study within
the project. Study selection activates the study functions. Functions
include: |
- 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
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| Additional DRP™
features: |
- Enforces a 21 CFR Part 11 compliant SAS programming
environment
- Management of a development/production SAS programming
environment
- Application level security to control access at a project
level
- Server-based application requiring only a web browser, i.e., SAS
is not required on the client
- Generates one stand-alone SAS program for each
listing, summary table, in-text table or graphic. The SAS programs
can then be executed on other platforms
- Allows for the inclusion of
custom SAS programs into the work flow
- Leverages current reporting software or commercially available
reporting software
- Provides support for multiple output formats, (e.g., ASCII, HTML,
RTF, PDF, XML) through full support of the SAS Output Delivery
System
- Centralizes management of project/study meta data (e.g., titles,
footnotes, report registration data)
- Allows report titles and footnotes to be defaulted and
modified
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| Custom Report Templates |
Your reporting needs are
satisfied through the Customizable Report Templates component of the
DRP™.
Report Templates are SAS programs. They generate user-friendly selection
screens that less experienced SAS users can use to produce stand-alone SAS
report programs. The Build Templates are used to configure your standard
reports with various user defined selections. The Report Templates
can produce both standard Tables, Listings and Graphics (TLGs) and
nonstandard TLGs. The DRP™
is delivered with several pre-configured Report Templates.
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. |
| Back-end
Report Generator (CR Toolkit™) |
| The DRP™ acts as a user
interface to the CR Toolkit™, the report generation software is stored on the
SAS server. Via the DRP™ thin-client user interface, the CR Toolkit™
produces the reports that are included in regulatory submissions. The CR
Toolkit™ is a comprehensive set of SAS macros that quickly and easily
generate reports, tables, listings and graphs. Data-driven tools provide
automated formatting of output based on the data submitted. |
