Celes Systems provides electronic information systems for conducting all phases of clinical trials. PRN Pharmaceutical Research Network provides a case study for the successful management of clinical trials using its long-term partner's Cirrus suite.
Cirrus is a modular, highly customisable and incredibly flexible system. Celes Systems allows partners and customers to implement tailor-made, competitively priced solutions for their unique project needs. Cirrus provides a wide variety of out-of-the-box customisations that meet most clinical trial requirements, as well as an industry-leading speed to deployment. PRN Pharmaceutical Research Network, for example, was able roll out new projects within in four weeks using Cirrus.
The system architecture is also able to replace certain parts of a system with specific development demands to comply with unique requirements, such as financial or reporting modules.
A comprehensive set of permissions and role-based access control to certain modules, features and subsets of data and case report forms simultaneously enable user-specific firewalls among project staff. For instance, PRN has customised Cirrus to separate the access of financial administrators from other personnel, allowing fiscal privacy for investigational sites.
In addition to its adaptability, the integration of electronic data capture and a randomisation subsystem allows for an intricate workflow and robust data checks during trials. The randomisation and EDC subsystems provide for timely scrutiny of randomisation requirements, stratification based on entered data and the provision of optional eCRF forms and pages, depending on the randomisation outcome.
Such integration eliminates the inherent risk of randomising ineligible subjects and wasting resources to collect unneeded data. PRN has used Cirrus to reduce the number of improperly randomised subjects. The system can also merge IP supply management and randomisation subsystems into the EDC to reduce the overall amount of IP required during a trial, or to closely manage tight supplies.
Cirrus is offered solely as a 'software as a service' (SaaS) solution, and, as such, does not require customers to invest in any kind of infrastructure. Instead, the underlying infrastructure is tailored to the requirements of the system and is provided as part of the integrated service. This benefits customers with predetermined costs for the duration of a project, no requirements for long-term investments and the elimination of technical skills on their side to manage these systems.
This makes Cirrus ideal for small and mid-size companies without the resources to provide the technical infrastructure, or with infrequent needs, to conduct clinical trials. Everyday management (user account management, for example) can be delegated to staff closer to the project (project manager, say, or CRA), eliminating the unloved helpdesk experience. Cirrus modifies the task distribution according to project needs, and is as flexible as the rest of the system.
The web-based set-up not only reduces the amount of support requirements for installing local applications, but also provides constant, ready access to the system for all authorised parties. PRN reports easier user acceptance for web-based Cirrus compared with local application EDC systems. Data entry and data review can be performed from any internet-connected device with a modern web browser, allowing flexibility for users who switch between devices during their usual workflow.
Since the user interface design was developed with simplicity in mind for all users, not just data managers, the intuitive interfaces help to minimise the learning curve for the system, reducing training overheads significantly.
Using an electronic information system for clinical trials makes sense. Integrating new features and modules, such as financial payment calculations and customised reports, is even more sensible. Customising your EDC system should be limited only by your imagination, never by suboptimal system tools and choices.