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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
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.?
?
?
?
?
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