Key Features
Our CRAB Nebula™ systems include technologies to securely capture, store, analyze and report data. Features include:
- Customizable Electronic Case Report Forms (eCRFs)
- Randomization (Interactive Web Response System)
- Data Visualization and Reporting
- Customizable Edit Checks
- File Uploads
- Medical Images
- Lab Management
- Automated Query Tracking
- Patient Evaluation
- Unified Database for Cross-Trial Analyses
- 21 CFR Part 11 and FDA Compliant
Nebula is tailored to cancer research but is also available for use on other types of clinical trials. Trial setup time and costs can be streamlined with use of our large eCRF and report libraries. Since CRAB has wide-ranging experience in clinical trials, these libraries cover a variety of disease types and study needs.
More About Nebula
Accessible
Web-based and accessed from most modern and secure web browsers with an internet connection. Easy-to-use, highly intuitive user interface. High availability.
Customizable
Built to be customizable and flexible, understanding that every clinical trial is unique. We partner with our clients to configure our system to meet the specific needs of their clinical trial. The CRAB Nebula EDC system has supported clinical trials for 20+ years.
Reliable
Secure encrypted transmission of trial data with the use of web-based electronic case report forms. Disaster recovery plan with daily backups and secure onsite and offsite storage. Software changes undergo a seven phase development process.
FDA Registration Ready
Our solution provides web-based electronic case report forms (eCRFs) for secure encrypted transmission of trial data, compliant with 21 CFR Part 11 requirements.
User & Site Management
Our Web Administrative Module provides quick and easy entry of user and site information. As an option, user accounts may be managed across multiple trials, enabling users to use their same login information for each trial. User roles, permissions, and access can be customized within each trial.
Practice Site
We provide both a live and a practice version of the trial EDC system. The practice version may be used for real time demos of the system during site initiation visits, and may be made available to trial users for use in their own time. CRAB Trainers are also able to assist your training regimen.
Calendar Tab
At the click of a mouse, CRAB’s Calendar Tab provides a centralized view of all study forms that need to be submitted or updated for a particular subject. Information about forms is summarized on the Calendar Tab and includes hyperlinks to related locations within the EDC system.
Study Arm Administration Tool
Authorized users open and close treatment arms to further enrollment using CRAB’s Study Arm Administration Tool (START). This tool is used in phase I and I/ II studies for treatment doses with a small target enrollment goal per dose when adverse event data indicate that a treatment arm should be closed early.
Third Party Vendors & System Integration
We will work with you to determine how we should configure our flexible EDC system to best meet the needs of each trial. We have experience integrating with a range of other vendors and their technology solutions (randomization, drug distribution, billing, imaging, etc.).
Study Announcements & Document Access
Password-protected access is provided to study announcements and documents, allowing the EDC system to become a central hub for trial activity and information. Our system provides our project managers with methods for posting documents and announcements in real time.
Team Portal
Clients with multiple trials may also request a branded password-protected Team Portal where site staff and collaborators can access trials and a wide variety of documents and reports.