1. EDETEK, Inc. | 1 Independence Way, Suite 405, Princeton, NJ 08540 | T: (609) 720‐0888 | F: (609) 720‐0880 | www.edetek.com
Panther EDCTM
Accuracy Performance Power Agility Passion Quality
Panther EDCTM
is an integrated component of Panther CTMPTM
. Together with Panther IWRS and Panther CTMS, Panther EDC offers
streamlined, standards based, and user friendly eClinical Solutions to today’s clinical trials that require the capacity to manage
complex study design, intricate workflows, while offering the best quality, efficiency, and the lowest cost.
Panther EDC is built on industry standards, such as CDASH, and comes with comprehensive library management capacities to ensure
reusability, consistency, and efficiency. Through an intuitive drag‐n‐drop interface, users can build eCRFs with all the edit check
programming within days. Comprehensive workflow and task management ensure that all activities are coordinated smoothly and
completed promptly. Built‐in as well as customizable reports provide insights to the study status and outstanding issues. Risk based
monitoring, SDV, patient profile creation, adjudication support, dashboard, unified portal, as well as easy integration and exchange
data with 3rd
party systems are the additional capacities that make Panther EDC one of the most mature systems available.
Panther EDC allows users to freely design eCRF layouts,
develop customized libraries and utilize standardized
templates. It even allows hybrid study design by supporting
the mixing of paper based and electronic data collection.
Panther EDC is equipped with
powerful features which can be
designed with the intuitive eCRF
Designer. It can take ODM as input,
and setup a fully functional EDC
environment in minutes.
Annotated CRFs with controlled
terms and data structure are one
click away. eCRFs can be published
into the library for future reuse.
The design file can be exported in
ODM for easy integration with
other systems.
Data Standardization
Reporting
Data RepositoryStudy Administration
Query
Management
Study
Management
Site
Management
Investigator
Management
Patient
Management
Data Capture
External Data
Integration
Coding
Monitoring
Standardization
(SDTM)
CRF Design
Forms & Items
Presentation
Layout
Edit Checks
Standardization
Rules
Administration Coding
CDASH
Sponsor
Standards
Edit Check
Library Document
Management
Unified Access Portal
Study Protocol
Web Services
External System
Panther CDMSTM

2. EDETEK, Inc. | 1 Independence Way, Suite 405, Princeton, NJ 08540 | T: (609) 720‐0888 | F: (609) 720‐0880 | www.edetek.com
Feature List
eCRF Development
 User friendly drag‐n‐drop interface
 Total control of screen layouts
 Support of CRF Libraries and Templates
 CDISC Standards Supported
(SDM/ODM/CDASH/SDTM)
 SDTM datasets can be directly generated
 Full multi‐arm, branching and workflow
management
 Dynamic field, record, form, and visit support
Study Management
 Role‐based site‐level security
 Support of hybrid studies (paper and EDC)
 Seamless integration of external data
 Built‐in risk based SDV and monitoring support
 Built‐in adjudication support
 Built‐in document management
 Task management
 CRF and SDV tracking
 Integrated medical coding
Monitoring and Quality Management
 Workflow based query management
 Real time and batch edit checks
 Support of complex cross form and cross visit
validation
 Full reports on edit checks and queries, complete
with links to data fields
 Onscreen annotation, query, validation and change
history at field level
 Soft and hard locks, as well as sign‐off at form, visit,
subject, site, and study levels
 Full 21 CFR Part 11 compliance
Reporting
 Customizable reports and alerts
 Messages and alerts can be displayed on dashboard
and distributed through email
 Full audit trail
 Patient profiles with graphs for clinical review
 Subject PDFs can be generated on demand
 All reports can be exported to CSV, Excel, and PDF
Integration
 All modules are integrated with Study Designer
 Seamless integration with other Panther eClinical
Solution modules, such as IWRS and CTMS
 Seamless integration with Panther CTMP,
streamlined processing from data collection to
statistical analysis and reporting
Unlimited Scalability
 Multi‐tier application provides unlimited scalability
 Support multiple data center global trials
Flexible Licensing and Service Models
 Hosted or in‐house
 Licensing or full‐service
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.