Statistical Control Environment
Today, regulatory reviewers want to verify results and assess the robustness and validity of submitted data. Biostats groups, therefore, need an easy way to automate end-to-end traceability between plans for analysis, the tabulation data and its values, the analysis data, and the analyses performed to streamline the submission readiness process, all while more efficiently meeting regulatory requirements.
End-to-end Traceability and Control
The Phase Forward Statistical Control Environment (SCE) offers complete
system control and end-to-end traceability within one environment
to fully optimize your statistical analysis workflows. In addition
to full user access control with complete versioning and auditing
capabilities, all of the data, Statistical Analysis Plan (SAP) specifications,
programs, macros and the outputs are automatically tracked by the
system to provide detailed dependency relationship links that can
be viewed graphically. These dependency relationships can also be
generated in reports and directly deposited into a document management
system, helping biostatistical groups easily manage, check and document
their work.
Reduce the Time it Takes to Collect, Rerun or Replicate Analyses
The Phase Forward SCE supports “as-of” processing that
allows retrospective analysis of data even after the CDR has been
updated. The system can create a snapshot of the CDR at a given point
in time, allowing analysis and results based on earlier data to be
reproduced. Data that was available at the time the conclusion was
drawn and submitted to regulatory authorities can then be included.
The “as-of” processing gives organizations the ability
to quickly and easily respond to regulatory requests during the critical
period of regulatory review.
The Most Up-to-date Information
Real-time status updates about existing data and information contained
within the environment are provided by the Phase Forward SCE. The
system lets users know if study components such as tables, listings
and figures are “up-to-date” or “stale.” The
ability of the system to track and manage the dependencies between
related elements in a study and take snapshots over time allows users
to always have access to up-to-date as well as historical information.
Decision makers are given the power to act on the latest information.
Streamline the Submission Readiness Process
The Phase Forward SCE can manage metadata for effective and efficient
submissions. Any organization submitting a New Drug Application has
to produce analysis and supporting data for its regulatory submissions.
For a single New Drug Application this could represent thousands of
analysis results and their associated datasets. Typically, this is
the last step in the analysis and submissions process and is currently
performed manually. This represents a significant manpower and time
investment near the critical deadline period of submission. Incomplete
or inaccurate documentation accompanying such a submission can result
in delays as regulatory authorities ask for clarifications and supplemental
submissions.
Using automation and software to ensure timely and accurate documentation for accompanying submissions streamlines this process. The system can create Define.pdf and Define.xml. The Phase Forward SCE also supports the direct publication of objects such as PDF reports to Documentum®, LiveLink® or other electronic document management systems.
