Target SAE System
In today’s clinical trials, data are often stored in multiple databases or data collection systems at CROs, EDC vendors, sponsors, investigator sites, or laboratories. These databases are often non-standard and proprietary. PharPoint can streamline these multiple and divergent data sources into a single, unified data repository. PharPoint offers the Target SAE System as a direct response to FDA’s Final Rule Amending IND Safety Reporting Requirements for the Industry [21 CFR 312.32 (c)(1)(i)(C)].
Target SAE System is a clinical data warehouse solution provided by PharPoint which provides a centralized, integrated system for data storage, analysis, reporting, and ad-hoc query of clinical data including information from the safety database. This solution will enable standardization of clinical data, efficiency in project programming, and data discovery options leading to improvements in the overall drug development process. The system can also provide a platform for compliance with the Final Rule as well as aid in FDA submission. Divergent data sources could include:
- Clinical Data Management systems (CDMS)
- EDC (Electronic Data Capture) systems
- Severe Adverse Event (SAE) Reporting systems
- Laboratory data
- Clinical Trial Management systems (CTMS)
PharPoint‘s clinical data warehouse repository provides for the construction and maintenance of a centralized data repository, integration of data from multiple data sources, including CROs and other external data vendors, and distribution of data to multiple output channels. Output channels include CDISC SDTM and reports facilitating study submission activities. The solution provides an environment that takes into account the specific FDA regulatory requirements for 21 CRF Part 11 software systems and results in submission ready datasets.
Components necessary for solution delivery include creating the warehouse data model, converting the CRO data from multiple data formats and processing the data in an iterative series of steps (ETL). Reporting on this data is accomplished through the use of standard SAS programming or web-base reporting.
PharPoint can create customized solutions including additional options or a la carte solutions including: a document management solution,
- Electronic signatures. Convert legacy data to CDISC SDTM compliant datasets
- SDTM compliant pooled database for ISS/ISE analysis
- Data Warehouse design and conversion
PharPoint will create clinical data workflows that transform chaos into clarity and provide an integrated vision for data collection, management, storage, analysis, review and submission.
