Establish libraries of standard, reusable templates in a consistent format
Producing high-quality statistical reports in a consistent format can be time-consuming and tedious work.
With the BioStats TLF system, libraries of standard, reusable templates can be established in the format you require.
BioStats TLF is a SAS based Report Software – FDA Submission capable -quality statistical table and listing authoring tool for creating the highest quality safety and efficacy tables, listings and patient profiles from any type of clinical data. Our software can create simple data listings as well as complex statistical summary tables, while supporting the unique data and presentation standards of your biostatistics team.
BioStats TLF has been adopted by many leading organizations, including several top tier pharmaceutical companies worldwide due to the ability to deliver superior presentation quality in a standardized, validated system. All BioStats TLF programs may be delivered to and executed by third parties such as sponsors and regulatory agencies. Hundreds of FDA submissions have been made using BioStats TLF software.
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. A complete library of more than 60 customizable safety table and listing templates is included.
BioStats TLF is designed to produce an expansive variety of reports, using any one-proc-away data structure including the CDISC ADaM standard. BioStats TLF is so flexible you can use it for marketing, financial or any other type of data analysis.
Rich Text Format (RTF) is produced directly from BioStats TLF for inclusion in word processing programs as native tables. A single style sheet may be used for all tables and listings regardless of the number of columns and rows. Additional style sheets may be defined to support the requirements of different sponsors or presentation types (submissions, publications, etc.).
Our report software includes the ClinPlus ADaM Data Conversion ToolKit and Template Library. This toolkit provides metadata-driven conversion of SDTM data to ADaM data and flexible production of metadata-driven safety tables and listings from the ADaM data structures, using custom or the included library of report templates.
BioStats TLF is the most flexible and powerful statistical table and listing production system available in the industry today. The true value is apparent in the time and money ClinPlus saves you in T&L development, quality control and final report assembly.
KEY FEATURES THAT COME STANDARD IN CLINPLUS: