Establishing clinical trial infrastructure

A critical step in the conduct of a clinical trial is to assure proper, reliable and auditable collection of data as well as the systems to be sure that any risks can be identified quickly and reliably, as participant safety is of paramount importance.

Based on our selection for the Dassault Systèmes accelerator, we now have access to the Medidata experts and tools. And that is a big deal. Medidata is arguably the premier electronic platform for conducting clinical trials. Their people work with a wide range of companies giving them unique insights that make them the experts any company would be lucky to have as advisors.

This week we started to work through the tools and structure of the Medidata system that would be the right size for Right Brain Bio. And here’s what that will look like as we plan for a fully electronic system, providing efficiency, reliability and cost savings.

1. The backbone of the system is the electronic data capture (EDC) module. You are likely familiar with this as it is akin to the electronic medical records your doctors and nurses use, although set up to ask for information specific to Parkinson’s disease and the clinical trial. It provides assurances that all the right information is collected in the right format.

2. Remote source review is a module that allows our monitors (and later, any auditor) to verify that the information in the EDC is accurate and supported by documentation. The power of this module is magnified because our monitors will be in the US and will be able to perform the verification of data entered in Australia.

3. The informed consent process will be documented through Medidata’s eConsent module.

4. Clinical data studio is a powerful module that allows the investigators and us, as the clinical trial sponsor, to see and audit data practically in real-time. Most importantly, this module makes all sorts of safety oversight possible with greater speed and greater accuracy, including the capability of sharing data with the independent safety committee that provides trial oversight.

5. In any clinical trial, video recording allows for independent verification of the results of questionaries and motor testing. The Medidata imaging module provides that capability.

6. The trial master file module provides the electronic platform for storing all the source documents suitable for submission to regulatory agencies.

7. Paying the clinical sites for testing is ordinarily a cumbersome process. But by interfacing with the other modules, the Medidata financial module assures that the right amounts are paid to the clinical sites when they complete testing at each visit.

Our data expert at Right Brain Bio is also experienced with Medidata, so despite how much work it takes to set up these systems, we have the right person to lead these processes. And that means we can realize the impact of these world-class experts and tools at Medidata (a unit of Dassault Systèmes).

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