Click Here For A Description of Monitor'sTM Suite Applications

 

The Monitor's SuiteTM is an integrated, flexible set of database tools specifically designed for Clinical Research Study Monitors, Project Managers, and Quality Assurance Auditors. The system permits easy entry and rapid retrieval of information with respect to clinical study sites, subjects, regulatory files, data quality and test articles. Designed for use on site or in-house, the system can utilize notebook and/or desktop computers, to facilitate:

  1. CRF data audits and their attendant data corrections.

  2. Creating an organized inventory of study file contents to ensure the presence of required regulatory documents and to help synchronize file contents at the study site, monitor and sponsor locations.

  3. Documentation and calculation of drug accountability and reconciliation for a wide variety of parenteral and oral drug formulations used in both in-patient and outpatient study settings.

  4. Maintenance of an up-to-date directory of clinical study site information.

  5. Generating Status Reports from a current subject roster in one or more single or multi-center studies.

The Monitor's SuiteTM is an application consisting of an integrated set of database templates for FileMaker® Pro for Windows (version 3.0 or later), and requires the proper installation and operation of licensed FileMaker® Pro and Windows 95/98 software.

The Monitor's SuiteTM applications are designed to aid in managing and monitoring clinical research studies. These applications are not designed or validated for the recording or storage of clinical research data or other research data management purposes, and should not be used for such. Changes to the content of database files may be made freely without the creation of an audit trail.


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