Question 1

What study levels does WiseCLIN support?

Accepted Answer

WiseCLIN supports risk management and oversight at multiple levels:

Clinical program
Clinical study
Investigator site

This allows organizations to identify and manage risks at the appropriate level while maintaining traceability between related programs, studies and sites.

Question 2

Does WiseCLIN support KRIs and QTLs?

Accepted Answer

Yes. WiseCLIN supports the configuration and management of Key Risk Indicators and Quality Tolerance Limits.

Organizations can define metrics, thresholds and alert levels, monitor results and use the information to support risk review and decision-making.

There is also an API integration to bring in this data from other systems.

Question 3

Is WiseCLIN suitable for CROs?

Accepted Answer

Yes. WiseCLIN supports CROs managing RBQM activities across multiple sponsors, studies and functional areas.

It helps CROs provide greater transparency, standardise risk management processes and demonstrate how risks, actions and escalations are being managed on behalf of their clients.

Question 4

Does WiseCLIN integrate with our current clinical trial systems?

Accepted Answer

Yes. WiseCLIN is designed to work alongside your existing clinical trial systems and data sources, including EDC, CTMS, eTMF and other operational platforms.

Integrations can be established through an API or through manual configuration, depending on your systems, data availability and business requirements.

Question 5

Can we migrate existing study risk assessments?

Accepted Answer

Yes. Existing risk assessments can be migrated into WiseCLIN, subject to review of their format, quality and level of detail.

During implementation, we assess your current spreadsheets or risk records, map the information to the WiseCLIN structure and support your team in transferring relevant risks, controls and actions without losing important study history.

Question 6

What happens during a demo of WiseCLIN?

Accepted Answer

During the demo, we show how WiseCLIN supports the complete RBQM workflow—from Critical-to-Quality factors and risk identification through to controls, actions, metrics, review cycles and documented oversight.

We also discuss your current process, systems and challenges so the demonstration can focus on the areas most relevant to your organisation.

You will leave with a clear understanding of how WiseCLIN could fit into your existing clinical operating model.

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