MainEDC™ RBM

Now that many companies project their roadmaps for 2021, we thought it would be good to offer something really useful.

Many of our advanced clients have built a risk-based approach into their business processes.

MainEDC™ provides extensive capabilities to support your specific risk management tactics. Risk based monitoring (RBM) has proven to enhance the clinical data quality as you consistently stay focused on the potentially problematic and most vulnerable data points.

At the same time, RBM aims at cutting the costs on your clinical trial conduct.

We help our clients understand, plan and implement this approach using MainEDC™ as the key data management tool. Here are just several prompts to where you can concentrate your efforts:

Critical data identification and management

Choose the data items that are crucial in assessing your study objectives. Typically, these would be the safety and efficacy endpoints.
Set up distinguished methods for critical and non-critical data validation and verification.
The system will clearly show what actions have been taken, by marking the critical data and trailing them.

Partial SDV

Decide what data need to be verified by CRAs and where this step can be omitted.
You can select the principle of verifying n% of eCRF pages or m% of Subjects at a site or even combine them.
The system will clearly show which fields and forms in eCRF have been verified and which ones have not.

Fully verified

Partially verified

Green fields are "individually" verified (e.g. critical data) and blue fields are "mass" verified in one click

Remote SDV

Use the remote SDV functionality saving on site monitoring visits.
Take this advantage to also reduce the risks of COVID-19 spread during the pandemic! Let the contaminated papers reside within the ICUs, use appropriately masked and attributed copies instead.
You can always return to on-site SDV later, to re-verify the critical data only.

Individual eCRF form

Full list

Site health assessment algorithms

This is the most powerful and instrumental function above all mentioned here as it links them all to build a systematic solution.
Set up KPIs at the site level and weigh each parameter periodically, one by one and altogether. Compare live snapshots with historic ones and assess the progress.
It totally depends on your choice what KPIs to use, what weight to assign for each parameter, when to make updates.