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Drug/Biologic/Device Development is Our Business
PRODUCTS - PAPERLESS CLINICAL TRIAL
(All Software Is 21 CFR Part 11 Compliant)

Please click on the title of the product for details.

Target e*CRF® - EDC Made Simple™
  • Used for over 150 EDC trials (since 1999)
  • Approvals:
    1. NDA (3)
    2. BLA (1)
    3. PMA (10)
    4. 510(k) (1)
  • In review:
    1. NDA (1)
    2. MAA (1)
  • 100% accepted by sites
  • Start a study in 3 weeks from final protocol
  • Protocol or study changes implemented in hours (not days)
  • One week from Last Patient Last Visit (LPLV) to database lock

Target Document®
  • Allows for a Internet-based Trial Master File (TMF) with eSignatures
  • User Friendly document management system
  • No software installed
  • Post, share, electronically sign, search, archive, etc. any electronic document
  • Users trained in less than 30 minutes
  • Can be used for any product where documents are shared and archived both within and outside of a company

Target Encoder®
  • Full integration with Target e*CRF®
    1. Used to code CRF terms to dictionaries (MedDRA, WHODRUG, etc.)
    2. Web based – no software installed
    3. Manually coded terms reside in user-defined dictionary and can be reused when identical term reappears

Target e*CTMS®
  • Features
    1. Study documents and timeline tracking
    2. Documentation of all study personnel
    3. Monitoring visits tracked
    4. Reports available to all authorized users

Target e*Pharmacovigilance
  • Full integration with Target e*CRF®
    1. Enter the data once
    2. Form populated with data pulled from Target e*CRF
    3. Medical monitor narrative entered within Target e*CRF
    4. Generates FDA approved facsimile of MedWatch Form 3500A

Target Newsletter™
  • Full integration with Target e*CRF®
  • Enrollment status pulled from database
  • Communication module with multiple address lists

Target e*CTR™ - Clinical Trial Record - Coming Soon
  • Full integration with Target e*CRF®
  • Electronic source document
  • Shift in monitoring paradigm

For additional questions or to schedule a demo, please contact:
Jules Mitchel, President
212-681-2100
julesmitchel@targethealth.com
http://blog.TargetHealth.com
http://www.targethealth.com