Octagon is uniquely positioned as an innovative technology and expert services company. This blend of expertise allows us to deliver a powerful and configurable technology platform that supports the unique needs of various types of clinical trials, observational studies and registries. The benefits of Octagon's technology and process experience extend to every client by cost-effectively streamlining and enhancing the implementation, data collection, administration and reporting of each project.
The ViewPoint ® FUSE team provides complete support for the discovery, design and development of an EDC study. Following deployment of the study, Octagon Customer Service and Managed Hosting Operations will provide ongoing support during the life of the study. Our proven methodology includes regular contact with clients utilizing a formal kick-off meeting, discovery and design meetings for system requirements and follow-up teleconferences to initiate the project. The team collaborates with the client on the development of the project plan, scheduling, coordination of joint team meetings, status reports and other project management functions.
The ViewPoint FUSE study development Methodology ensures successful study build and deployment of the ViewPoint FUSE environment including eCRF, database and user interface design, integration with external systems such as IVRS and Central Vendor data, final data export and delivery of submission compliant PDF files. The team also provides comprehensive user training for all aspects of the ViewPoint FUSE environment. A suite of 13 standard reports is available to clients throughout the engagement.
Project Management
The ViewPoint FUSE Project Management Team is comprised of industry veterans who are highly experienced in all aspects of the management of clinical trials, early and late phase studies, safety surveillance studies and registries. The ViewPoint FUSE Project Manager supervises all of the ongoing day-to-day aspects of the EDC portion of the study. The Project Manager guides the study team through the detailed implementation process, deployment and training on the solution, followed by continual support through the lifetime of the program.
Data Management Support
Our team has extensive experience designing and configuring EDC solutions that streamline the data management process. We are able to reduce the number of resources required to design and manage a study by automating many common data management tasks. Our expertise can be leveraged throughout the data management lifecycle (CRF design through database lock). Octagon's data management team is dedicated to providing quality results in a timely manner by incorporating quality checks throughout the data management process. Our team understands that the data generated from the trial will one day be submitted to regulatory authorities and all tasks are completed with that goal in mind. Octagon data management integrates final delivery steps into day-to-day processes, such as the incorporation of SDTM standards into database design.
SDTM Compliant Case Report Forms
Octagon has developed a set of 26 SDTM compliant standard Case Report Forms ("CRFs"). These CRFs have been designed with the SDTMIG 3.1.1 in mind. The CRFs use controlled terminology (where applicable) in accordance with the model. By creating these CRFs, Octagon is greatly reducing the amount of re-work needed for SDTM conversion upon final export of data.
Superior Data Quality – ViewPoint FUSE's interactive edit checks clean data at the point of data entry, and the system's task-oriented user interfaces ensure easy maneuverability within the system. Octagon's EDC system is unique in that it also includes integrated site and data management features that facilitate remote monitoring and timely data management. By providing bi-directional communication capabilities within the EDC system, your company will be able to communicate with sites and view study tracking and data quality metrics in real-time.
Real-Time Alert of Safety Events - Rapid notification and tracking of Serious Adverse Events is a major driver for choosing EDC over paper. The integrated Safety Reporting capability within ViewPoint FUSE captures AE data in real-time as events are reported by investigator sites. The Safety Reporting interface's interactive design allows users to sort the listing by site, subject, type of AE, by date, as well as those marked serious.
Local-Language Interface – ViewPoint FUSE provides the ability to provide a customized user experience to facilitate differences in language, dates and monetary formats across investigator sites. All text, icons, banners and messages are stored in resource files that are easily translated to any language including those requiring double-byte characters.
Speed and Responsiveness – ViewPoint FUSE has been designed to accommodate connections as slow as 56kb/s dialup and is compatible with many different web browser applications and versions. The user interface for the study will be designed using standard browser code and functionality to ensure a consistent look and feel regardless of the client application used. As a completely web-based application, ViewPoint FUSE does not require the installation of any software on the local machines and does not require complex technology such as Terminal Services or Citrix.
Secure Hosting
At Octagon, our commitment to data integrity goes beyond our software to encompass every aspect of our EDC Solution. Our host hardware is located in a secure, managed hosting facility used by many well-known Internet presences. The co-location facility has many layers of redundancy for power and connectivity, as well as state-of-the-art fire suppression; all to ensure data is accessible when you need it. Each study database is mirrored in real time and backed-up nightly to a tape storage unit. Tapes are changed each week, and an industry-leading data management company keeps the previous six weeks of backups off-site in a fireproof vault. The tapes are checked periodically to ensure the validity of the backups.
Monitoring is constant (24 hours a day, 7 days a week), and notification procedures are defined and documented to ensure that both hardware and software problems can be remedied in a timely fashion. Scheduled maintenance is performed outside of regular business hours to minimize the impact of any planned downtime for our customers.
Technical Support
Octagon provides technical support for all ViewPoint FUSE users. Our highly qualified technical staff specializes in issues related to computers, Internet service, and hospital firewall problems. All calls received are logged and tracked within our online issue tracking system to ensure timely response and rapid resolution for every issue.
- Standard ViewPoint FUSE EDC Technical Support is provided Monday-Friday, from 5:00AM to 5:00PM Pacific Time
- Technical support is provided in English
- Extended hours of operation and multi-lingual support are available upon request
Training
Octagon offers tailored ViewPoint FUSE training for all study implementations. The ViewPoint FUSE training package includes the following components:
- Train-the-Trainer Sessions
- Investigator Meeting Support
- Study Specific EDC User Manuals
- Training Website allowing users to train on an exact replica of the production database
