RFP

Built on Clinical Trial Expertise and Technology Innovation

Calyx CTMS is a leading enterprise solution to plan, administer and track every aspect of global clinical trials from start-up to closeout. A centralized system to orchestrate all operational and administrative activities throughout the clinical hierarchy, it allows biopharmaceutical sponsors and clinical research organizations (CROs) to intelligently manage the complexities of clinical trials by simplifying workflows and proactively managing risks across the trial lifecycle. Containing all operational trial data, the solution allows consistent and accurate information to be shared across the entire enterprise, thereby facilitating timely and informed decision-making.

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CTMS Tracking & Management

CTMS tracking and management handles the planning and tracking of all projects and trials, providing ongoing visibility on the health of clinical programs to enable robust operational oversight and transparency. This includes participating countries and sites, to details of the patients and their progress. It holds all information relating to the trials such as milestones, visit designs, timelines, enrollment and site activation metrics as well as detailed issue/contact tracking.

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CTMS Monitoring

The site monitoring functionality is an online/offline web-based tool that supports all aspects of site management and monitoring, including collection of site monitoring data, milestone planning, protocol deviations, issues and subject recruitment. Data collected automatically populates the monitoring visit report, with the entire review and approval process being managed within the CTMS system. Calyx CTMS also supports a secure, unblinded monitoring capability suitable for independent drug monitoring or other monitoring functions performed by an unblinded monitor. Available on laptops and tablets, it provides optimal system portability and flexibility for site management and monitoring.

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CTMS Monitoring Mobile App

The monitoring mobile app is an exciting new solution that allows site monitors to work offline using their iPhone or Android smartphones. The app empowers site monitors to manage clinical site data anytime with simple and intuitive navigation. Users can access site and subject information, start a monitoring visit, capture and review issues for faster resolution. The App supports contemporaneous and efficient completion of monitoring tasks while eliminating extensive note-taking and data discrepancies. In addition, it integrates with Outlook email and calendar for optimal flexibility.

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CTMS Clinical Cost Tracking

The clinical cost tracking manages the planning, projection and tracking of costs associated with clinical trials by employing multi-center, multi-currency and full-cost analysis functionality. With a sophisticated and automated investigator payment facility which can be integrated with corporate accounting systems, it provides a full payment generation, review and approval process, facilitating financial management of hundreds of sites at a time.

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CTMS Investigator

The investigator functionality provides a profile of investigator data and enables selection of the best investigators for future studies. Dynamic lists can be created to be shared, refined and reviewed for site feasibility. The functionality helps maximize the value of historical data with analysis of investigator performance, experience and expertise, lending valuable decision support for investigator and site selection.

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CTMS Regulatory Document Tracking

The regulatory document tracking streamlines the onerous and challenging task of ensuring timely and complete regulatory documentation for the study. The functionality focuses on collecting the right documents during study start-up to get investigative sites approved and activated on time. It can be adapted on a trial-bytrial and country-by-country basis to ensure the correct documents are gathered, whether an FDA 1572, an informed consent approval or a protocol signature page.

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CTMS Task Management

The task management functionality helps focus and prioritize user attention on those activities requiring attention based on date or status. CTMS is a large system with users often supporting multiple sites across studies. Instead of users running reports or unfocusedly browsing the system, the functionality presents a realtime, dynamic “to do” list of milestones, site visits, and other events. Users can drill into the record to make necessary updates, return to the task management screen, and select the next record requiring their attention.


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