Services
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