GlobalSys EDC
GlobalSys EDC is a niche electronic data capture (EDC) platform serving clinical trial sponsors, contract research organisations (CROs) and academic study sites in the DACH region. EDC is the clinical-research category that replaces paper case-report forms with a validated electronic system that captures, cleans, queries and exports patient data for regulatory submission. GlobalSys EDC competes in a market dominated globally by Medidata Rave, Veeva CDMS and Oracle Clinical, with a smaller European cohort (Castor, OpenClinica, ClinCapture) and a long tail of specialist DACH-localised products. GlobalSys EDC positions for mid-sized sponsors and investigator-initiated trials that need GCP-compliant data capture without the licensing weight of the global platforms.
Functional scope
GlobalSys EDC covers electronic case report form (eCRF) design, patient enrolment, data entry by site staff, automated edit checks, query management, source-data verification workflow, audit trail, electronic signature, and regulatory-grade data export in CDISC SDTM and ODM formats. Study-builder tools allow trial managers to configure eCRFs without programming, with conditional logic and validation rules. The randomisation and trial-supply-management (RTSM) module is included or available as an add-on depending on the licence tier. The product covers the standard EDC scope expected by regulators but is less broad than the full clinical-data-management suite that the global platforms provide.
GCP and regulatory compliance
The platform is designed around ICH GCP (Good Clinical Practice) and 21 CFR Part 11 (the FDA electronic-records regulation), with the audit trail, electronic signature, role-based access control and validation documentation that those frameworks require. The vendor supplies system validation documentation (URS, FRS, IQ, OQ, PQ templates) for the sponsor's own validation file. EU GDPR compliance covers the patient-data privacy requirements; data hosting is in EU data centres. The vendor publishes its computer-system-validation approach and supports sponsor audits of the platform as part of standard onboarding.
Target user segment
GlobalSys EDC targets mid-sized pharmaceutical sponsors, contract research organisations and academic clinical-trial units in DACH that run small to mid-sized clinical trials (typically up to a few hundred patients per study) and want a GCP-compliant EDC without the per-study licensing weight of the global platforms. Large pharma sponsors running multi-thousand-patient registration studies typically remain on Medidata, Veeva or Oracle Clinical; very small investigator-initiated single-site studies often use OpenClinica or REDCap. GlobalSys EDC sits in the middle of that spectrum.
Pricing model and TCO
Pricing in the EDC category is typically per-study with a base platform fee and a variable charge based on patient count, eCRF complexity and study duration. GlobalSys EDC sits below the global platforms on a per-study cost basis, which is the primary commercial argument for the mid-sized sponsor segment. The vendor does not publish list pricing centrally; buyers should request a written quote with the specific study scope, patient count, site count and required modules (RTSM, ePRO, integrations).
Selection considerations
GlobalSys EDC is a credible choice for mid-sized DACH sponsors and academic CTUs running GCP-compliant clinical trials at a study scale where the global platforms are commercially out of reach. It is less compelling for large pharma sponsors with multi-study global portfolios where Medidata, Veeva or Oracle Clinical provide deeper integrations with safety, central-lab and ePRO systems, and for very small single-site investigator-initiated studies where REDCap or OpenClinica are commonly sufficient. Sponsors comparing GlobalSys EDC should validate the system-validation package depth and the regulatory-submission export quality (SDTM, ODM) for their specific therapeutic-area requirements.
Related Topics
Vendor homepage of Globalsys EDC
Current view of the website https://www.globalsys.de/
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Frequently Asked Questions
Is GlobalSys EDC 21 CFR Part 11 compliant?
Yes. The platform is designed around 21 CFR Part 11 with the required audit trail, electronic signature, role-based access control and validation documentation. The vendor supplies the computer-system-validation package supporting sponsor inspections.
Does GlobalSys EDC export CDISC SDTM?
Yes. Regulatory-grade data export in CDISC SDTM and ODM formats is part of the standard product, supporting FDA and EMA submission packages. The export configuration is typically reviewed during study setup by the data-management team.
How does GlobalSys EDC compare with Medidata Rave?
Medidata Rave is the global pharma-industry EDC standard with the deepest integration ecosystem (safety, central lab, ePRO, eTMF) and the largest validated user base. GlobalSys EDC is materially smaller and less feature-broad but is more economical at the mid-sized-study scale and is locally supported in DACH. The choice typically comes down to portfolio scale and integration breadth.
Where is the platform data hosted?
In EU data centres, in compliance with EU GDPR for clinical-trial patient data. Sponsors can review the hosting and validation arrangements as part of their vendor-qualification process.