PharPoint Research

 
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Data Warehousing Service

In today’s clinical trials, data is 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.

A clinical data warehouse solution provided by PharPoint will provide a centralized, integrated system for data storage, analysis, reporting, and ad-hoc query of program clinical data. 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 regulatory compliance as well as aid in FDA submission. Divergent data sources could include:

  • Clinical Data Management systems (CDMS)
  • EDC (Electronic Data Capture) systems
  • 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 standard data models in CDISC standards 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.

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 will be accomplished through the use of standard SAS programming or web-base reporting. Additional options could include document management solution, change/version control, work flow, and electronic signatures. The results of a clinical data warehouse would be to create datasets that are submission ready.

PharPoint offers the following data warehousing services:

  • Convert legacy data to CDISC SDTM compliant datasets
  • SDTM compliant pooled database for ISS/ISE analysis
  • Data Warehouse design and conversion

PharPoint can create clinical data workflows that transform chaos into clarity and provide an integrated vision for data collection, management, storage, analysis, review and submission.