| ToxVision™ is
the software platform that PharmQuest has architected
in collaboration with FDA reviewers. It receives nonclinical
data in SEND format and makes it available for on-demand
review. Reviewers at CDER plan to use ToxVision for
reviewing and analyzing toxicology and carcinogenicity
data submitted by sponsoring Pharmaceutical companies.
FEATURES
The primary benefit of the ToxVision™ platform
is more efficient and faster review of applications.
FDA reviewers will use ToxVision™ to accept data
in SEND format, extract data from various datasets and
analyze it.
SEND Compliant
ToxVision™ is SEND (Standard for Exchange of Nonclinical
Data) compliant. SEND is an open standard that will
be used to submit data to the FDA. The system will receive
and validate nonclinical data in SEND format.
Standards Based Technology
ToxVision™ is implemented using open and portable
technologies. The core of ToxVision™ is based
on J2EE, which is an open Java standard for implementing
enterprise software systems. ToxVision™ uses Oracle®
database for the data repository. The system is designed
so that it can be deployed on a variety of platforms,
including Windows and different flavors of UNIX.
Connectivity to Other Tools
The system will provide functionality to export the
data to common tools and formats like Microsoft Excel
and SAS Transport.
Easy to Use Web Interface
The system provides a web interface for easy deployment
and convenient access. The system will enable users
to query the data and perform toxicological assessments.
A general overview of how the data
from sponsor companies will be received and analyzed
by the FDA is shown in the following picture. The various
components of the system are described following the
picture.
SEND Data Package
As part of the pilot project, sponsor companies are
submitting nonclinical data in SEND format. All study
data is formatted and packaged as per the specifications
outlined in SEND.
Data Validator
Data sent by the sponsor companies is validated before
being uploaded into a database server. The Data Validator
component validates the incoming data for compliance
to SEND standard and generates a validation report.
On successful validation, the data is uploaded into
the Data Repository.
Data Repository
Validated data is uploaded into a central repository.
This repository is designed to handle the large amount
and variety of data expected in the submissions.
Analysis Engine
Once the data is uploaded into the data repository,
it is available for analysis. FDA reviewers use the
ToxVision™ to review and analyze the data. The
Analysis Engine is the heart of the ToxVision™
platform. It is designed to respond to reviewers’
queries. It dynamically builds and presents textual
as well as graphical views of the data under review.
It also enables export of data into various other analytical
tools routinely used by FDA reviewers.
A few screenshots from ToxVision™
system are included here to highlight some of the features
of the system.
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