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Agile – Focus on Operations

September 15, 2020 @ 2:00 pm 2:30 pm

Speaker: Yuliya Fontanetti, Senior Director – Operations and Compliance, HRW

Convenor: Tracy Machado, Pheonix Healthcare


Everyone is talking about agile, since its inception in the technology industry, the desire to produce better, more customer-focused outputs faster and more effectively, is what virtually every industry has been striving for. Pharma is no different. Customer centricity, putting patients at the heart of medicine’s design as well as the fast-paced world we live in today, mean that pharma companies have to adapt to the changing environments, creating solutions that are current and relevant for their target audience.

Benefits of agile are clearly too great to ignore, however, operationally, there are a number of challenges that need to be considered when undertaking an agile project.

This paper will explore some of the intricacies of agile approach, starting from respondent recruitment, where innovative solutions are required to meet challenging timelines; material design and translation execution, both of which requiring careful quality control with increased turnaround times; not forgetting the value of an outstanding moderator, who is able to really understand end-client’s needs and become an extension of clients’ vision whilst completely immersing themselves in the project.

However, by far, the most fundamentally-crucial part of agile project design to consider as early as the project kick off is compliance,  building compliance considerations into the project from the kick off, involvement of medical and approval teams from the get-go and re-approvals following material iteration, all of which need to become part of a carefully orchestrated execution that will, no doubt, deliver relevant, customer focused insights to our clients.

At the end of this paper, you will, hopefully, come away with some practical solutions on overcoming some of these challenges and being able to embrace agile approach, whilst having the necessary tools to allow the project to become a success.  

Yuliya Fontanetti

Yuliya Fontanetti

Senior Director – Operations and Compliance, HRW

Having worked in the healthcare MR arena for most of her career, Yuliya’s passion for uncovering research insights has been supported by gaining robust experience across numerous therapy areas and methodological approaches. Yuliya combines her extensive experience in compliance, guideline adherence and high quality data collection expertise with an avid interest in using innovative approaches to uncover research insights in an agile and efficient way.

An ambassador for ethical compliance and guidelines, Yuliya is a regular speaker at various industry events on topics including data protection, compliance and agile. In the context of the “new normal” it has become more important than ever to maintain agility, to adapt and iterate in line with the changing environment, thus delivering more meaningful customer outcomes and this plays to Yuliya’s strengths and passion.