Clinical Data Repository
As the volume of scientific data continues to grow, integrating electronic data capture (EDC), electronic patient reported outcome (ePRO), labs, trial supply information, images and other data sources into one central system can help reduce the time and effort associated with managing multiple point-to-point integrations and streamline data management activities.
Data Integration/ Version Control
The Phase Forward Clinical Data Repository (CDR) is designed to handle
data, files, programs and documents for all trials within one central
environment. The system provides the flexibility to easily configure
the repository to meet the needs of any organization. In addition,
the Phase Forward CDR provides out-of-the-box integration for EDC
systems like InForm™ that helps automate system set-up and the
delivery of data, including queries, CRF status information and links
to make it easier for data managers to quickly navigate to the data
source. The CDR also helps automate the data import process and provides
complete traceability between related objects managed by the system.
Any modifications or deletions to the audited objects are kept in
an accessible “audit trail” that is visible through standard
reports.
Simplify and Automate Tasks — Metadata
Driven System
The Phase Forward CDR is a metadata driven system that helps simplify
database set-up, provides end-to-end traceability and assists with
the automation of repetitive tasks. The metadata driven system captures
every data handoff, data change and data point association—providing
a scalable way for organizations to effectively manage continual flow
of new information and improve overall quality and integrity.
Multi-stakeholder Access and Collaboration
The security model of the Phase Forward CDR allows controlled access
to objects stored within the data repository, which facilitates and
safeguards the sharing of sensitive information between various groups
such as partners and collaborators, including data management, biostats
and CROs. The information stored in the data repository tables can
be accessed based on relevant business needs.
Validate, Review and Transform Imported Datasets
Clinical data can come from a wide variety of sources and formats,
such as SAS®, ASCII or XML datasets, throughout the trial lifecycle.
The Phase Forward CDR allows an organization to validate, review,
update, transform, organize and track the information from one environment.
Users can quickly validate new datasets by comparing it to the defined
study metadata within the CDR. The new datasets can then be easily
reviewed, corrected and transformed using many tools, including the
built-in Phase Forward CDR Query Builder Interface. In addition, the
CDR has plugins to applications such as SAS®, Excel®,
Spotfire®, IReview® and JReview® to support
the entire process from within one environment, including cleaning
and reviewing. Data can also be converted to and from SAS datasets
to Oracle data structures on a scheduled basis. This includes generating
standard views such as CDISC’s SDTM standard.
