PPD Informatics' TableTrans 2.1 Provides Advanced Security

PPD Informatics, the clinical data consulting services and software solutions division of PPD Inc, announced the release of TableTrans 2.1, an innovative data transformation software that supports compliance with federal regulations governing electronic records and signatures submitted in new drug applications.

TableTrans is a versatile software tool used for data migrations and integration, populating data warehouses, creating statistical data sets and exchanging data with other sources. The new features of TableTrans enable users to configure the software to their specific requirements for security, user access and auditing in support of generating data for submission to the Food and Drug Administration in compliance with federal regulations issued in 21 Code of Federal Regulations (CFR) Part 11.

When using TableTrans 2.1 to migrate data in a regulated environment, clients now have the capability to limit access to authorized individuals within five different privilege levels based on job roles and functions. The enhanced software ensures that only authorized individuals can use the system, alter a record or perform steps and operations in the permitted sequence. TableTrans uses encryption to block unauthorized attempts to open and run TableTrans data transformations and generates a secure, time-stamped audit trail.

"The new features of TableTrans 2.1 represent significant advancements in the areas of security and auditing that support the creation of 21 CFR Part 11-compliant applications and solutions," Liz Rolison, vice president of PPD Informatics, said. "From the outset, we designed TableTrans for ease of use and quality performance, and we continue to seek enhancements that help our clients successfully manage complex clinical data challenges."

Working with the Oracle relational database management system (RDBMS), TableTrans helps to generate, store and document code for complex data transformations in an easy-to-use visual manner. TableTrans allows users to develop complex data transformations visually by connecting a series of graphical icons, each representing a distinct data transformation task. The proprietary software will automatically generate the structured query language (SQL) code from the diagrams, execute the transformation and provide an interactive environment for data review. In addition, both the diagrams and the generated code can be stored for reuse. Designed for the rigors of clinical data processing, TableTrans also documents the transformations and summarizes the data for design review and quality assurance.

The upgrade version of TableTrans 2.1 is now available, and current subscribers to PPD Informatics' TableTrans annual maintenance plan will automatically receive this advanced software tool.

PPD Informatics provides clinical data consulting services and software systems for the pharmaceutical and biotechnology industries, government and drug development service providers. With offices in the U.S. and Europe, PPD Informatics designs, develops and implements clinical research computer systems and provides proprietary software tools to manage complex clinical data projects. PPD Informatics is a division of PPD Development, the drug development services subsidiary of PPD Inc.

PPD Inc, www.ppdi.com, is a leading global provider of discovery and development services and products for the pharmaceutical and biotechnology industries. With a corporate mission to provide services that maximize the return on clients' R&D investments, PPD provides innovative technologies, therapeutic expertise and comprehensive services for drug discovery and preclinical programs, Phase I-IV clinical development and post-market support. The company has more than 3,800 professionals in 48 offices in 20 countries around the world.