Phase 3 Study Begins Using Target e*CTR as eSource and Associated Risk-Based Monitoring

 

A meeting was held with FDA on 19 July 2012 to discuss our approach to the paperless clinical trial and Risk-Based Monitoring and no obstacles were identified. Minutes of the meeting, redacted, are available by request. Since that time, Target Health is pleased to announce that a fully paperless Phase 3 clinical trial has begun. In terms of software:

 

  1. Target e*CRF®is being used for EDC (24 approvals to date). In addition to the standard functionality of EDC, Target e*CRF includes:
    1. Real-Time Direct Data Entry (RT-DDE) at the time of the office visit using Target e*CTR™ as the eSource software
    2. Target Encoder® for medication and AE coding
    3. Target Monitoring Reports™ for Qualification, Initiation, Interim (central and onsite) and Closeout Visits
    4. Target e*Pharmacovigilance to generate Form 3500A and CIOMS1 forms
  2. Target Document® for the eTMF
  3. Target e*CTMS for study startup and project management

 

In addition, Risk-Based Monitoring has been implemented using the Clinical Data Monitoring Plan (CDMoP).

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

 

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