Update on Our Progress:

Engaging with CROs to work with RBB to Execute the Trial

We reached an important and exciting operational milestone. Well, at least it is exciting for me. This week several contract research organizations (CROs) responded to our request for proposals to provide assistance with launching and executing our Phase 2A clinical trial (which include the resources and associated costs of conducting the trial).

A CRO is an organization that provides the people, tools and expertise to execute the work required to launch, conduct and analyze a clinical trial. And they don’t just work for small companies like Right Brain Bio (that could not afford to hire all the professionals that each CRO brings to bear to execute a trial). Big pharma uses CROs regularly as well, as they’ve found it more efficient financially not to have such teams employed all the time when they are only used some of the time. 

The proposals from these CROs are quite detailed. After all, they need to show how they can perform all the tasks and what these tasks will cost. The work ranges from submission to the FDA requesting permission to conduct the trial to identifying and contracting with the clinical sites that will perform the trial. A big part of qualifying sites is making sure they have the right expertise and commitment. While that is going on, we’re working with the CRO to set up the database to collect and store the data securely and store all the documentation about the sites and the trial. And we’re setting up the advertising to make sure people with Parkinson’s and doctors focus on Parkinson’s are aware of the trial. The CRO will be visiting the site to make sure all the data are captured accurately and that the people who enroll are the types of people we agreed with the FDA will participate. These are just a few of the tasks required to successfully execute a trial that the CROs are proposing to us, and represent intensive work for 4-6 months even before the first person is treated in the trial.

I’ve always enjoyed this part of the process – as unsexy as it appears – because it means we are getting closer to launching the trial and because it is so, so important. These proposals show impressive expertise and experience, as they see problems that need to be addressed and identify opportunities we did not imagine. The proposals are detailed – generally consist of 40-50 pages of information – plus detailed Excel spreadsheets with all the calculations leading to the total costs proposed. This is an important learning opportunity for how we can increase the efficiency and reliability of the clinical trial conduct.

So now we will dig in, consider their recommendations and proposals. We’ll certainly look at the costs, but that is probably less important for this stage of a project than the confidence we gain about each as our potential partner. Can they help us make the study design better, in terms of protecting the participants and getting to the answer faster and with more confidence? Do they offer operational expertise, Parkinson’s expertise, or both?

We’ll study and compare the proposals, ask for clarifying information and then select 2 or 3 as finalists with whom we will meet. As long as we continue to progress with our fund raising, the CRO could start in July, the request to conduct the trial could be submitted to the FDA in July and we could start treating people in the study as soon as by the end of 2025.