Prelude Computer Solutions, Inc.

  Clinical Trial Qualification, Monitor and Auditor Management

The Clinical Trial Qualification, Monitor, and Audit Management Software for Quality Assurance automates the process of monitoring Clinical Trial sites by the corporate Quality Assurance unit.

This software, designed in conjunction with a major pharmaceutical client, provides a methodology for auditing the clinical trial sites in accordance with the "Food and Drug Administration Compliance Program Guidance Manuals".  

The three major categories of Clinical Trial Monitoring are: 

  • Sponsors, Contact Research Organizations and Monitors (CP 7348.810)
  • Clinical Investigators (CP 7348.811)
  • In-vivo bioequivalence, institutional review boards (CP 7348.009) and toxicology laboratories (CP 7348.808)

The Clinical Trail Quality Assurance database facilitates compliance with these FDA standards by offering a structured and flexible methodology for recording all relevant information concerning the monitoring of a study.  Ample provision is provided for entering notes, comments, follow-up actions and dates, and other narrative information. 

The major benefits are: 

  • Monitor those events that are critical to the investigation.
  • Create reports on Audit Activities based upon the needs of a protocol.
  • A searchable database for answers to inquires about who, what, why and where across all Studies.
  • Guidance for entering and monitoring Clinical Trial information
  • Maintains Study attributes and statistics such as Screened, Entered, Randomized, completed, etc?
  • Records information on Key Study Dates:  (Protocol and IRB information, Clinical Supplies, and enrollment start date, etc.)
  • Essential Documents Check List.  An extensive table that that facilitates monitoring all aspects of records retention for both in-house and on-site documents.
  • Information on Study site locations, clinical investigators and all contacted personnel.
  • Comprehensive reporting for front line management review.
  • Summary Extracts for executive review.
  • Program can be run on portable and allows for use at site locations.
  • The Audit Activities and Essential document check lists are table driven and can be easily revised or upgraded as regulations evolve.
  • Audit Certificates.



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