We are developing a quality-assured and fully regulatory-compliant Electronic Data Capture (EDC) system for use in regulated clinical trials.
To achieve this, we maintain a comprehensive Quality Management System (QMS) in which we structure all regulatory requirements (requirement specification) and document the respective technical implementation (functional and design specification). Upon request, we grant customers selective read access to this QMS.
Unless otherwise agreed, all data is processed and stored in the ISO 27001-certified Telekom Cloud in Germany.
ICH Compliant GCP E6
ICH GCP E6
International clinical trial standard focusing on ethical conduct, data quality, and patient protection.
Among others, ensured by:
Logged role and rights system for write and read permissions
Two-factor authentication (mandatory per study if desired)
Source Data Verification (SDV) and Query Management
FDA Compliant 21 CFR Part 11
FDA 21 CFR Part 11
Regulates electronic records and signatures in clinical trials to ensure data integrity and traceability.
Among others, ensured by:
Automatic and audit-proof audit trail with timestamp
Cryptographic electronic signatures after re-login
Password policies and automatic logout during inactivity
EU Compliant Annex 11
EU Annex 11
Supplements the EU-GMP guidelines and describes requirements for computerized systems in pharmaceutical manufacturing.