Controlling the risk is one of the most important thing for a CRO. That’s why it is fundamental have professionals that can manage and guarantee patient safety. Here Cecilia Pelagatti – our CRO Scientific Director and responsible for Pharmacovigilance – tells us how she puts in place all her knowledge of intensive Care and Emergency Medicine in this new professional experience.
The first thing I understood when I started working in JSB CRO, more than one year ago, is that this environment needs professionals with a wide range of knowledge. It is necessary to know the Regulatory basis, how to manage contracts, GCPs and also pharmacovigilance; fields that a person with a clinical background doesn’t know thoroughly. So I started to analyse how my background could be an added-value to a CRO specialized in Advanced Therapies.
I decided to focus my attention on three different aspects: Advanced Therapies, Medical Monitoring and communication among the actors involved in the study and I asked myself: how can I make a contribution to these different areas? First of all, when we talk about Advance Therapies we talk about innovative studies on rare diseases to find new opportunities to treat injuries. In this case, comprehending the specific clinical study is fundamental. The role of a physician, who perfectly understands the importance of scientific literature consultation, is necessary so as not to stop at the findings but to take the time to analyse and study the topic with attention and care.
Secondly, the importance of Medical monitoring in order to assess adverse events, both serious and not, that could arise during the clinical study, especially in Phase I/II of the studies. Also unexpected adverse events can arise during the study; in this case you need to use all your curiosity to discover the reasons behind these kinds of events, which usually aren’t obvious and immediate.
Finally, the communication between different professionals with different background cannot be seen as a problem but rather as an opportunity. Each person involved in the clinical trial has the same goal: find the most effective treatment for the patient. But the point of views are sometimes opposite: if a physician can look at the rules as a limit for patient care, it can be extremely important for a monitor to take the data as stated in the protocol. The connection between different ways of thinking can create the perfect balance to conduct the study.
Looking at the future of JSB CRO, I believe that our team is ready to face new challenges and opportunities, always trying to implement our knowledge of the single study in which we are involved and the communication between all parties, keeping in mind the responsibility that we have toward patients.