OPIS applies standardized and established data management processes to ensure integral, analysable data and real-time availability in a secure and protected environment.
- EDC Platform(*)
- Study design
- eCRF/database creation (customized to company requirements)
- CDISC Standards
- IVRS/IWRS set-up
- Edit check implementation
- Query management
- Data cleaning
- SAS Programming
- Listings and Patient Profile creation
- Data review
- Project status and metrics reports
- Medical coding
- SAE reconciliation
- Protocol Deviation management
- Drug management
- Safety management
- Laboratory management
- Third-party data handling
- Training and Technical Support
All our procedures are ICH/GCP and GDPR compliant
(*) Clinical.net is an OPIS brand and was thoughtfully created as a solution to manage clinical trial data in a complex international environment.
Systems are FDA CFR Part 11 compliant and ISO 27001:2017 certified, all user-friendly modules are customizable and external sources of data are easily integrated.