Key Features
Customizable Randomization Systems
Offers adaptable web-based randomization tailored to various research designs, including stratified or grouped randomization systems. Supports adaptive designs for flexible randomization and product assignment, accommodating evolving trial requirements.
Product Management and Tracking
Manages assignment of research products to treatment arms, oversees stock tracking, and ensures proper disposal. Allows detailed tracking of product logistics and inventory through the entire trial lifecycle.
IVR and Symptom Tracking
Employs an Interactive Voice Response (IVR) system to conduct surveys and monitor symptoms, enabling real-time communication with trial participants. Provides instant notifications to research teams on adverse events or other critical data points.
Regulatory Compliance
Ensures compliance with KVKK, FDA, and GDPR regulations, maintaining software and reporting standards in line with global privacy regulations. Adheres to FDA CFR 21 Part 11 compliance, ensuring secure handling and documentation of electronic records.
Security and Infrastructure
Data is securely hosted on Omega CRO’s servers in Turkey, which are certified with PCI-DSS v3 security protocols and meet NATO AQAP standards with TIER 4 infrastructure. Guarantees high levels of data security and accessibility to protect sensitive research data.
Rapid Deployment
Fast setup and deployment with a turnaround of 4-6 weeks for web-based IWRS/IVRS software, including validation, training, and operational readiness. Supported by a dedicated team offering continuous technical support and assistance.
User-Friendly Interface
Provides an intuitive interface that facilitates easy use for research teams and field personnel, streamlining trial operations. All modules are designed for use through a single, unified interface for efficiency and ease-of-use.
Scalability and Adaptability
Scalable design tailored to the size and scope of each study, from single-center to multicenter trials. Supports adaptive trial designs and multi-language capabilities, ensuring broad applicability.
Volunteer Management
Enables efficient volunteer randomization, ensuring adherence to randomized lists and accommodating stratification needs. Provides tools for managing volunteer data and ensuring alignment with trial protocols.