Evidence & Performance Blog

Lorena Levi, Trainer at Fundacion Cecilia Grierson in Argentina, is sharing with us her experience in operational and performance management in South / Latin America.

Lorena and myself talked about this in the past week, and I am now sharing her thoughts with you.

[BZ] Can you please tell us about your experience in clinical research?

[LL] I have been more than 4 years doing basic research, at University of Buenos Aires. There I did my PhD. I have so much training in clinical research, like GCP training, Phase I training, Local regulations, study coordinator and monitoring training.

In 2006 I have started to work as a free lancer in a clinical study as study coordinator, at Fundacion Thompson at the present. The study is sponsored by the NIH.

In 2007 I started to work in ACLIRES int, a CRO specialized in Phase I and II  trials. I am now part of Fundacion Cecilia Grierson as a trainer, a non-for profit foundation that trains people for the excellence in clinical research in Argentina.

[BZ] Comparing to other geographical areas, what are, for you, the main benefits in the operational management of clinical Trials in Argentina and more globally South & Latin America?

[LL] Argentina is a highly regulated country very well renowned for the quality of both Investigators and CRAs. 95% of the research done there are Industry sponsored studies.

The Health System is public so people can always choose to get free medical attention as an alternative to research studies.

The Latin American region in general offers diverse patient populations, cost efficient research services from investigators and CRO and has been growing steadily but consistently which reassures quality through experience and training.

[BZ] What is the point of view of the performance of the investigational sites in this area and How do you assess the performance of the investigational sites?

[LL] Records indicate findings have been reduced in several ways (presentation available on demand) and lessons have been learnt by Researchers, particularly in Chile and Argentina.

[BZ] With your experience, what are for you the frequent reasons of delays during the Clinical Trial Process?

[LL] Regulatory Agencies take their time to review, for example in Brazil and Argentina; but once study is approved enrollment rate will usual catch up with the rest of the word rapidly.

[BZ] What are the clinical implications of these findings - in other words, how will they affect the overall performance of the clinical trials and how can we solve it?

[LL] As experience increases and more and more research is done, regulatory authorities will tune up with review timelines and may be able to shorten review times.

[BZ] What is your point of view about the benefits of the Clinical Trial Performance Management?

[LL] It is always important to identify and manage arising issues correcting documenting and designing prevention plans for findings not to repeat themselves in the future.

We provide clinical site and CRA study specific, corrective  training services at Blanchard & Associates www.blanchardyasociados.com.ar

Thank you Lorena for taking the time to answer our questions!