PRA transforms clinical trials with an innovative approach to pharmaceutical and biotech drug development and highly skilled teams of dedicated personnel.
EXACT™ software is a breakthrough in drug development unique to PRA. This new system empowers the user to treat data in a standardized format across clinical applications, projects or trials.
What is EXACT™?
- EXACT™ is a comprehensive and flexible system replacing traditional, manually programmed processes with automated, reusable programs for:
- Data extraction
- Data transformation
- Statistical reporting
- Electronic publishing
- EXACT™ works by extracting or importing both clinical and non-clinical data from different areas and stages of clinical development, and then integrating the data in a regulatory-compliant manner for rapid analysis and reporting
- Data can be viewed and analyzed at various levels, with each module offering a set of editable features
EXACT™ Benefits for Clients
- Significant process savings on multiple task items from data extraction to statistical reporting through the use of unique industry processes and software
- Streamlined documentation for use within submission documentation
- Consistent, automated output
- Improved quality
- Allows for re-use of mappings and TFLs via a library
Key Features of EXACT™
- Designed to work with CDISC (Clinical Data Interchange Standards Consortium) models as well as client-specified standards
- Automates tasks that have previously involved researchers and biostatisticians manually writing and validating programs
- Replaces time-consuming work with an efficient model enabling SAS programs to be rapidly constructed by re-using pre-determined, but configurable, standards.
- Full data traceability
- Generation of specification documentation required by regulatory authorities (for example, DEFINE.XML)