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GxP-Box Clinical Research

Clinical Trial Support for IMP and Medical Device as follows:

  • Handling and Support of Ethic Committee submission (principally for Germany)
  • Handling and Support of Competent Authority (CA) application and EudraCT Clinical Trial Application(CTA)maintenance
  • PIS/IC development & design
  • Monitoring of clincial trials Phase II -III and NIS
  • Study documentation according to ICH-GCP electronically with EDC and paper based CRF
  • IMP Handling
  • Study Site Selection and Feasibility Study/Check
  • Initiation Visits, Site Monitoring, Co-Monitoring, Close Out Visit

GxP-Box Quality Support

QC, QA and QM Support:

  • Clinical Trial Monitoring according to ICH E6
  • Planning and Performing of System-, In-house- and On-site Audits according to ICH E6
  • SOP System: Development (locally, regionally and globally) and Process Management
  • IT System Validation and Technical Documentation
  • CAPA Management
  • Deviation/Violation Management
  • Document Review and Compliance Management

GxP-Box Training

Training Support:

  • Support, set-up and maintenance of Electronic Learning Management Systems (ELMS)
  • GCP Training Curriculum set-up
  • GCP Training Courses

GxP-Box IT

We provide individual information technology solutions:

  • Technical Documentation
  • Programming: Java, Java-Script, VB, VBA, PHP, Ruby, xml, xsl
  • IT-Validation: DQ, IQ, OQ and PQ
  • IT Document Management interfaces and e-Signature solutions
  • Development Environment: NetBeans, VisualStudio and Eclipse