Interview with Dr. Sippy Kaur
Dr. Sippy Kaur
Senior expert, Medical devices (non-active medical devices and IVD medical devices)
Role in Coroprevention: Clinical Trial Manager
Q1: Could you tell us a bit about yourself?
I have a PhD in cancer genetics. During my postdoctoral research I have worked on several types of cancer (e.g. gynecological, colorectal cancer, soft tissue and bone sarcomas) in order to investigate the epigenetic mechanism underlying the cancer initiation and progression. For the last 2 years I have been working at the Finnish Notified Body as a lead auditor and product assessor for medical devices. I am qualified for MDR, IVDR and assessment of sterile medical devices.
While working for a notified body I gained tremendous amount of experience on medical devices and it gave me insights into how to improve the overall processes related to the safety, quality and performance of the product, which among others are the key elements for manufacturing good quality medical devices.
Q2: Could you tell us more about your organisation?
I joined the team and CoroPrevention project on 1st October 2021.
We, at Tampere University, are the CoroPrevention coordinating site and the official sponsor of the CoroPrevention randomized clinical trial (RCT). I believe my work experience at the notified body and previous scientific experience at the university related to teaching and supervision will contribute to the successful coordination and management of the CoroPrevention project.
Q3: What is your role in the project?
I will be mainly working as the clinical trial manager but also supporting the UniWeb’s team to prepare the technical documentation according to MDR and the Quality management systems in compliance with ISO 13485:2016 for the new CoroPrevention mobile application to be developed and soon finalized
Q4: How did you become interested in your research area?
I was looking for an opportunity to stay in academia and also use my knowledge on medical devices. Therefore, joining CoroPrevention was the right next step for me to apply my skills and acquire new ones.
Q6: Can you describe your work and how it is related to CoroPrevention?
I will be overseeing the clinical trial from the sponsor’s perspective and collaborating closely with the professional CRO team at Crown CRO. At Crown Mia Mäkinen will be my closest partner and we’ll do everything possible to run the large trial fruitfully. In addition, I’ll be providing support and guidance to the application development teams regarding the medical device regulations and any matters related to quality management systems for the medical devices. Finally, I’m also prepared to help in the general management of the whole CoroPrevention project e.g. during the hectic moments of the EU reporting and whenever the Coordinator’s desk is overflowing …
Q7: What do you like most about your work?
I am excited to be part of this study because the Clinical trial in this project is quite large. I see this as an opportunity to use my existing knowledge and also learn new things.
Q8: Why do you believe CoroPrevention is important?
To my knowledge this is the first time when a complex digital system will be tested in a large scale prospective RCT to generate compelling evidence for personalized prevention. This has a true potential to change and improve patient care in the future.