1. EDETEK, Inc. | 1 Independence Way, Suite 405, Princeton, NJ 08540 | T: (609) 720‐0888 | F: (609) 720‐0880 | www.edetek.com
Panther Data Standardization Platform (DSPTM
)
Accuracy Performance Power Agility Passion Quality
Standardization can improve clinical research through increased efficiency, enhanced quality, better data integration, streamlined data
exchange, higher‐level of regulatory compliance, and facilitation of regulatory review and audits. But done incorrectly, it can also incur
additional costs, delays, confusion, lost transparency, and even worse, lowered data quality.
Architectural Considerations
Panther DSP provides fully metadata driven and
scalable solution to company wide data standardization
needs.
 The separation of semantic, logic, and physical
layers ensures easy user adoption, smooth
integration, as well as decoupling of changes from
application requirements or standards.
 Physical implementations are completely
automated, reducing project cost and time.
 The centralized metadata repository provides easy
access and sharing of metadata through multiple
channels, such as dashboard or web services API.
Panther DSP has been used in hundreds of studies,
bringing the unmatched performance and
manageability to data standardization projects of all
sizes.
Benefits
Leveraging industry standards and metadata
technology, Panther DSP strives to achieve the
highest quality, and highest efficiency, while
lowering the overall costs. Business rules and
processes are defined at the scientific concept
level, and only need to be defined once.
Comprehensive library and template support
ensures 100% reusability.
Panther DSP’s unique layered architecture
isolate end users from implementation details
and standard changes. Aligned with industry
standards and regulatory requirements, Panther
DSP protect today’s investment from future
changes.

2. EDETEK, Inc. | 1 Independence Way, Suite 405, Princeton, NJ 08540 | T: (609) 720‐0888 | F: (609) 720‐0880 | www.edetek.com
DSP/EX
DSP/EX is an enterprise focused centralized metadata and data repository based on the BRIDG model. The Study Architect is the central module
which manages all the study metadata extracted from the Protocol, and SAP, as well as industry and company standards. These metadata are
used to drive down‐stream modules, including Study Conduct (EDC, IXRS, CTMS, etc.), Study Analysis (Biometrics), and Regulatory Applications.
Study Conduct
Protocol SAP
CDR
Standards
Study Analysis
SDTM
ADM
Analytical
Reporting
TLFs
Visualization
Business and
Scientific Activity
Monitoring and
Reporting (BAM)
PPVs
Study Architect
Custom
MDR
BRIDG Based
Metadata and
Data Repository
Panther DSP/EX utilizes a semantic layer that masks
the underlying complexities, making it easier to
interpret the data without ambiguity.
Because of its flexible data design structure, the
BRIDG model provides a single definition of the truth
which leads to enhanced data quality and semantic
interchangeability. The BRIDG model is application
agnostic, providing the bridge between all physical
applications and systems.
Through partnership with Actio SolutionsTM
, Panther
DSP/EX offers business activity monitoring and
reporting capabilities to proactively manage study
events at real time.
Panther DSP Features
Usability and Efficiency
 Intuitive User Interface
 Modularized Rule Development
 ISS/ISE Support
 Integrated Validation
 Automated Submission Package Creation
Metadata Driven
 Impact and Dependency Analysis
 Knowledge Management and Auto‐Mapping
 Compliance and Consistency Evaluation
Workflow Managed
 Version Controlled
 Team Collaboration
Library Support
 Standardization Routine
 Data Profiling
 Fully Integrated and Open Architecture
Integrated and Open Architecture
 Integral Component of CTMP
 Role Based Security
Scalability and Extensibility
 Unlimited Customization and Expansion
Standard Support
 Automated Code Generation
 Unlimited Scalability
 Full Comparison
About EDETEK
EDETEK, Inc., a CDISC Registered Solutions Provider, is an innovative CRO that provides high‐quality technology and service to
pharmaceutical, biotechnology, and device companies. We utilize our in‐house Panther platform, which was developed under
ISO 9001:2008 certified processes, to fulfill our clients’ data engineering and business analytics needs. Our comprehensive
metadata driven solutions offer unparalleled advantages in terms of data quality, time to completion, and cost efficiency.