ClinicalTrialSuite is a comprehensive Clinical Trial Management System (CTMS) solution we developed to manage the entire life cycle of clinical trials in the digital environment.
All processes are managed in a single system — from site management to electronic case report forms (e-CRF), from query management to source data verification, from real-time monitoring to long-term archiving.
The system includes the following modules:
- User management (investigator, site coordinator, CRA, data manager, data monitor, project lead)
- Site management (single-center, multicenter)
- Study document management
- Electronic Case Report Forms (e-CRF)
- Subject inclusion / exclusion (screening)
- Randomization
- Query management
- Data cleaning
- Source data verification (SDV)
- Audit trails
- User action reports
- Data lock and database lock
- Data export
- Long-term archiving
Multiple clinical trials can be conducted simultaneously on the system.
The system can be used for single-center or large-scale multicenter retrospective and interventional or observational prospective clinical trials, and for national or international registry studies. In addition, patients can be included in the process for the direct collection of patient-reported outcomes (PRO) without compromising data protection (KVKK) compliance.
The system is fully compliant with and validated against FDA 21 CFR Part 11, which defines the requirements for electronic records and electronic signatures.