CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS):
Our CTMS is a flexible, controlled multi-server environment for running high performance, secure clinical studies. Our Optimized Hosting resides in a SSAE 16 Type II SOC 1
data center and meets ISO 27001 standards for information security.
The data center statement and associated documentation may be made available for viewing by client as part of a vendor audit.
Highlights Include:
- Validated and optimized for running CTMS Enterprise with the highest level of security and
GCP compliance - Blazing speed and reliable performance on the Akamai network
- Zero data loss
Technical Features:
- Dedicated application server for each client Supported Instance
- Powered by fastest solid state hard disk technology available (Fusion-io) – run data extracts 5x faster!
- Hardened application server and database server security via Cisco ASA firewall, intrusion detection, traffic encryption
- Multi-site redundancy architecture for disaster prevention and recovery
- Security audit report
- Data centre secured by key-cards, biometric scanning
and surveillance - Constant network monitoring for latencies and intrusion and predictive failure
ELECTRONIC DATA CAPTURE:
- CRF development
- Rules configuration
- Documented testing
- Study validation documentation
- Data migration
- Systems integration
Our team will help ensure your study’s success by:
- Implementing your study to maximize ease-of-use
- Configuring edit checks and rules to ensure data is of highest quality
- Tailoring the study configuration to your protocol’s data management and analysis needs
- Providing critical regulatory documentation
Reference: https://www.openclinica.com/optimized-hosting
INTEGRATED WEB RECOGNITION SYSTEM:
- Our IWRS automated randomization systems use the modern statistical methods, programming and authentication procedures. This guarantees quick, correct patient assignments, balanced and valid subject assignments.
- The IWRS functionality totally organises and maintains the drug supply from initial shipment to re-supply thus guaranteeing proper kit numbers and the monitoring of defective or damaged supplies.