EDEDTEK, Inc. is a pioneer coupling metadata technology and CDISC standards in Clinical Data Management applications. Our mission is to fundamentally change the way the Clinical Data Management process is viewed and practiced.
While metadata is used in many standard programs to store and locate items, EDETEK takes this a step further by integrating metadata technology with CDISC standards. EDETEK's Panther CDISC SuiteTM essentially automates the Clinical Data Management process from protocol design through submission.
EDETEK has developed the Panther CDISC SuiteTM family of products to successfully address the Pharmaceutical industry 4 primary goals:
Reduced Trial Time to Completion
Faster Access to Data
Dramatically Reduced Cost
Panther CDISC SuiteTM is end-to-end, CDISC compliant, and modular. Working in concert with the Sponsor and managing CRO, CDISC SuiteTM dramatically simplifies the entire Clinical Data Management process.
During the trial set up, the protocol, Sponsor standards, and SAP are "mapped" to CDISC standards (PR, CDASH, ODM, LAB, SEND, TDM, SDTM, ADaM, Report).
CDISC SuiteTM is then able to place each individual element of data in the location required in the Clinical Data Management process as it is collected. Collection can be through the resident automated eCRF module, third party eCRF system, safety labs, images, specialty labs and the like.
Through its resident SAS programming, code is internally generated, TLFs are automatically populated, and statistical analysis is automatically performed.
Results from the initial protocol and SAP mapping, collected data, TLFs are defined and statistical analysis generated to be placed in the Report module following ICH E3 guideline. Data elements are transparent end-to-end and there is no 'Black Box Syndrome'. Output can be in any preferred format.
Trial set up time is typically less than 2 weeks
Reduced sources of input
Reduced possibilities of input error
Time and cost savings at all process points
Trial data is standardized enterprise wide across trials and therapeutic areas
Define once, reuse-everywhere features / standards / cost benefits
CDISC compliant / submission ready data and reporting – no future conversion costs
All data is validated in several hundred ways as it is entered
Resident eCRF module is largely automated
Seamless interface with most available EDC systems
Automated SAS programming (only validation programming required)
TLFs are populated in real time as data is received
Web portal unified access
Reduced Clinical Monitoring time
End-to End data transparency
Built on CDISC standards
The Panther CDISC SuiteTM is demonstrably robust, complete, deceptively simple, and cost effective.
EDETEK is a member of CDISC and a member of 6 CDISC Standards development teams.
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