Full Press Release Details
• November 18, 2024
“It is especially important to create strong relationships with all of the people involved in the study to make sure that there is effective collaboration.” – Vered Sasson, Lead CRA
As a clinical research associate (CRA) I was looking to join a biotech company that is mission- driven and involved hands-on in conducting its own clinical trials. At NeuroSense, I’ve found this desired sense of fulfillment where every action contributes directly to advancing life-changing therapies.
I have been working at NeuroSense for more than 2 years now. For the first year, I was the lead CRA for our Phase 2b PARADIGM study, leading the initial start-up phase right through to the database locks.
My role included both field work as well as regulatory aspects. The field work entails traveling frequently to the clinical site and being the main point of contact between the site staff and NeuroSense. Keeping close connection with the primary investigator, sub-investigators and study coordinators, and supporting them in their day-to-day work ensured successful collaboration.
Secondly, as a natural part of a CRA’s line of work, I was responsible of overseeing the integrity of the trial conduct according to local regulatory guidelines, protocols and good clinical practices (GCP).
First and foremost, these guidelines help the sites, as well as the CRA to ensure the well-being of the patients involved in the study. It was important for us to convey to the patient, through the site staff, how valuable they are to NeuroSense.
Furthermore, monitoring work focuses on ensuring proper and accurate data collection and documentation, so that at the end of this journey, the trial will have reliable results that will advance the development of the new drug to the next stage.
In the last year I have been involved in a more cross-functional role as the Lead CRA. I work closely with our CRO`s different trial teams (data managers, biostatisticians, and the clinical team), and develop study plans and strategies for both the PARADIGM and RoAD trials. One of my more exciting and interesting responsibilities is data management. In this role, I am working with different EDC (electronic databases) platforms, developing databases, engaging in data review and conducting clinical coding.
A clinical study is a complex process that involves numerous moving parts and collaborations across different teams, each with specialized roles. From the protocol design, site management, patient recruitment, data collection and all the way to data analysis- all aspects must synchronize to ensure the trial’s success. It is important for me to not only practice this collaborative approach, but also to stay updated on the latest regulatory changes and GCP guidelines to contribute to the success of clinical research, driving our shared mission forward.