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CALYX.AI Give Your Teams the Tools to Do More CALYX CTMS

CALYX CTMS Give Your Teams the Tools to Do More

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C ALY X . A I

Give Your Teams the Tools to Do More

CA LY X C T M S

©2021 Calyx 2

Industry-proven clinical trial managementYour clinical trials deserve every chance to succeed. And your study teams deserve the most effective tools to improve trial quality, compliance and efficiency. Calyx CTMS is the solution.

Since 1992, Calyx has pioneered the field of clinical trial management, delivering an effective CTMS that improves trial efficiencies and drives successful clinical development programs.

Worldwide biopharmaceutical companies and CROs repeatedly turn to Calyx to meet their CTMS needs.

Optimized through the delivery of 45,000+ trials, Calyx CTMS can adapt to meet the complexity or simplicity of your clinical trials and processes.

– Reduce trial risks, ensure compliance

– Optimize the future, learn from trial performance

– Improve data quality and boost productivity

Join the world’s top 20 pharmaceutical companies and CROs who rely on Calyx CTMS and leverage its industry-proven features to:

©2021 Calyx 3

Reduce trial risks, ensure complianceWith Calyx CTMS, you leverage robust functionalities that reduce trial risks and ensure compliance at multiple levels.

KEY BENEFITS – Avoid study delays and/or increased

study costs by tracking planned vs actual

recruitment and enrollment so that correction

plans can be implemented in a timely manner.

– Complete your start-up processes faster by

utilizing study specific templates.

– Monitor planned vs actual site initiation and

enrollment and pivot accordingly.

– Help your monitors focus on the right

tasks by providing key site information and

customizable checklists.

– Ensure compliance of monitoring visit reports

using end-to-end workflows with electronic

signatures for creation, review, and approval.

– Ensure financial compliance and payment

control through fund and payment

authorization workflows. Streamline planning

and management of site payments.

– Ensure compliance regarding expiring

documents with proactive notifications.

Calyx CTMS allows you to control the execution of all your trials, including timelines and data quality.

©2021 Calyx 4

Optimize the future, learn from trial performanceMake informed decisions to improve your trial’s success through efficient cross-study analysis. Calyx CTMS enables you to centralize the operational data of all your historical trials into a single source – removing the need for separate data sources – so that you can learn from past trial outcomes to optimize current and future trials.

KEY BENEFITS – Identify emerging trends in your current trials.

Calyx CTMS has been used to analyze the

COVID-19 pandemic and observe, in real time,

drops in site visits and increases in remote

visits, country by country.

– Get inspiration from previous successful trials

to build realistic plans for your next trials.

– Select the optimal sites to increase your

study’s chance of meeting timelines

(subject recruitment challenges, start-up).

Select qualified investigators by monitoring

experience and performance metrics.

©2021 Calyx 5

Improve data quality and boost productivityRely on Calyx CTMS as the heart of your clinical system and the source of truth for all your operational data including information about the study, country, site, personnel, vendor, etc. Seamlessly connecting your CTMS to the rest of your ecosystem is critical to ensuring good data quality (and avoiding discrepancies between systems), ultimately boosting the end user’s productivity.

Leverage our expertise in integrating Calyx CTMS with your other eClinical systems. You will be able to configure and activate our standard integrations, as well as collaborate on custom integrations.

KEY BENEFITS – Use our standard integrations with top EDC,

IRT, or eTMF systems:

– Avoid painful double data entry and realize real time recruitment information from your EDC system.

– Help ensure you’re inspection ready with instant access to monitoring visit reports through integration with your eTMF systems.

– Leverage our extensive experience to build custom integrations with your key systems.

Contact [email protected] to learn how Calyx’s expertise in CTMS can drive efficiencies and ensure the success of your trials.

©2021 Calyx 6©2021 Calyx 6

Change the way monitors workThe Calyx CTMS mobile application empowers monitors to manage clinical site data anytime, anywhere.

– No Internet? No problem!

– Quick and easy access to site and subject information

– Navigation is simple and intuitive

– Risks are immediately identified, allowing for faster resolution

– Monitoring tasks are completed quickly and efficiently

– Extensive note taking is eliminated and data discrepancies are reduced

– Instant communication with clinical site staff

– Integrates with phone, mapping, Outlook apps, and Calyx CTMS

– For use with iPhone and Android