Benefits of Using ViewPoint FUSE
System Design
When ViewPoint FUSE was designed, the functionality of each user role was taken into account. The design team put themselves "into the shoes" of a Site Coordinator, Investigator, Data Manager, Clinical Research Associate (CRA) and Sponsor and tailored the roles to fit each of those needs. The system also has an enforced workflow, which ensures that each CRF is completed according to the time and events schedule in the protocol. This enforced workflow is configurable, if the protocol design necessitates the study coordinator to skip over forms. If data changes are made to previously submitted data the workflow is invalidated and the records must be re-submitted. This guarantees compliance with CFR Part 11.
Base Study
In order to address the long start up times typically associated with EDC trials, Octagon offers a “base study” which serves as the basis of all EDC builds. Regardless of therapeutic area or phase protocol, key eCRFs (electronic Case Report Forms) such as Demographics, Medical History, Physical Examination, Vitals, Adverse Events and Concomitant Medications are needed. The base study contains 19 standard eCRFs built with the principles of SDTM in mind, fully validated and containing validation checks and display rules.
When working with a sponsor, we determine how many base study forms can be used and how
many custom forms (efficacy, drug accountability) need to be designed decreasing set-up time
up to 50%.
Superior Data Quality
ViewPoint FUSE 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. ViewPoint FUSE is unique as it includes integrated site and data management features that facilitate remote oversight and timely management. By providing bi-directional communication capabilities within the system, your company can communicate with sites and view study tracking and data quality metrics in real-time.
Real-Time Alert of Safety Events — The integrated Safety Reporting capability within ViewPoint FUSE captures Adverse Event (AE) data in real-time. 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 for internet operation at 3G data connection rates and above. It is compatible with Version 6 & 7 of Microsoft’s Internet Explorer. The user interface for the study uses 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 installation of any software on the local machines and does not require complex technology such as Terminal Services or Citrix.
eCRF Screen Design
ViewPoint FUSE allows flexibility when designing eCRFs. Because the system is web based, the typical constraint of an 8 ½ x 11 piece of paper is obsolete. During eCRF design, show/hide panels enable clients to develop dynamic eCRFs based upon answers to previous questions. These show/hide panels allow users to follow a “script” when completing the forms enabling quick and quality data capture. To further clean the data while doing data entry at a site, the ViewPoint FUSE platform runs all data entry checks (hard checks, automatic queries, and soft edit checks) upon saving the form. This immediate feedback for both single variable and multi-variable rules greatly reduces the time to subsequently clean data, which dramatically reduces the time to data lock. Utilizing the base study forms as much as possible reduces database setup time, saving both time and money.
CFR Part 11 Compliance
The viewpoint FUSE system is CFR Part 11 Compliant. It contains a secure, username and password prompted signature from the Investigator to mark records as PI signed. Along with electronic signatures, ViewPoint FUSE has an integrated audit trail which is accessible from the eCRF page. The audit trail is human readable and can be exported to Excel. Once data has been submitted and saved to the database, any data modifications made post submission are subject to stringent rules. A reason for change field appears at the bottom of each form chronicling the item or items changed, user who made the change, old value/new value and date and time stamp of the change. The user must also provide the explanation of the change (Data Entry Error, Query Resolution) and this is saved in the database. At any point in time, a sponsor, authorized user or auditor can use this audit trail to trace data changes. For ease of use, the most recent data changes are sorted to the top of the audit trail.
Workflow Definition
To help the site know when a subject has an upcoming visit or when a visit becomes overdue, a visit workflow engine is integrated within the ViewPoint FUSE platform. Once the first form is saved for a subject, an internal clock starts running within the system according to the specifications from the visit schedule. The integrated scheduler sends automatic email notifications to alert key project team members of any upcoming or overdue events so that appropriate action can occur.
Listings
Navigation through subject records is simplified through a variety of listings within ViewPoint FUSE. These listings are designed to provide authorized users the key information that will allow the real time management of their clinical trial. The listings contain statistics on key areas such as Query Frequencies and Aging, Subject Status, and Form Statistics. The listings can be exported into Excel for off-line viewing. The listings are also real time so users do not have to wait for a nightly refresh; data is available within seconds of saving to the sytem. The listings include:
- Query Listing
- Site Listing
- Form Listing
- Subject Listing
Administration
ViewPoint FUSE includes an administrative interface for easy site and user management. This interface allows authorized individuals to create and edit user accounts within the system. Once a user profile is created, a user can be assigned a temporary password to enter the system. To automate one of the most frequent uses of the Administration function, there is a built-in “Forgot Password” mechanism that allows users to reset their own password upon correctly answering a set of security questions. This convenient feature eliminates the need to call a helpdesk to reset a password.
Secure Hosting
At Octagon, our commitment to data integrity encompasses every aspect of our EDC solution. Our host hardware is located in a secure, managed hosting facility located in Philadelphia along with a second location in St. Louis, Missouri. The 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 storage company keeps the previous backups off-site in a fireproof vault. The tapes are checked periodically to ensure the validity of the backups. Actual study data is replicated via Microsoft SQL High Availability database configuration in which the study database is replicated between 3 servers. Generators can run indefinitely, so power loss would never be a risk in this particular environment.
Backups are stored on tape media on-site. 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.
