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The Critical Role of Biostatistics in Streamlining the Preclinical to Clinical Pathway



June 16, 2021

Access on Demand Webinar Here.

Please note that this webinar was presented in Mandarin.

Obtaining market approval for a new product can create several clinical challenges for medical device Sponsors. One way in which to tackle these challenges head-on is to develop effective biostatistics processes and plans early in the development process to navigate these complexities.

NAMSA invites you to listen as our expert Biostatisticians discuss strategies and best practices proven to help Sponsors efficiently meet clinical evidence needs and achieve market approval. Case studies will also be shared that detail insights obtained during each stage of development, how to select the most efficient study design and the best use of innovative statistical methods to mitigate risk and accelerate timelines.

Attendees of this webinar can expect to gain a better understanding of:

  • Maximizing the value that Biostatisticians add by engaging them early for effective collaboration
  • The unique insights Biostatisticians provide regarding complex study designs, from preclinical through post-market studies
  • How NAMSA Biostatisticians draw upon diverse experiences and expertise using state-of-the-art methodology to achieve Client success

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Luoxi Shi

Senior Biostatistician

Luoxi Shi has 4 years of experience in medical device research, both in industry and CRO. She is currently located in the US and supports preclinical, pre-market and post-market studies.  As a Biostatistician, Luoxi has participated in FDA and NMPA regulated studies with experience in providing statistical support for study design, writing statistical analysis plans and executing analyses. Luoxi has been working in clinical studies in multiple therapeutic areas, including cardiovascular, peripheral vascular, sleep disorders, transplantation, wound care and neuromodulation.

Shuang Zhu

Senior Biostatistician

Shuang Zhu has more than 8 years of experience as a Biostatistician in both pharmaceutical and medical device CROs. Before joining NAMSA, Shuang worked in a top 3 global CRO with experience in rheumatoid arthritis and diabetes. After joining NAMSA, Shuang leads and supports various medical device clinical trials, with experience in multiple therapeutic areas, including cardiovascular, wound care, dental, ophthalmology, IVD and preclinical studies.