Day: May 13, 2023

What is Non-Inferiority (NI) all about?

The Wise son: In clinical trials, it is not always about demonstrating that the new product (or test, or treatment) is superior. Sometimes it is necessary to demonstrate that the product is as good as a reference product, but has some other qualities, such as: fewer side effects, an easier administration or it is more […]

What to consider when calculating sample size for non-inferiority (NI) study?

The Wise son: In the previous post, we discussed non-inferiority (NI) study design. The first thing you need for establishing sample size for NI study, is to establish the NI-Margin (margin). It may be necessary to evaluate the sample-size (N) sensitivity to a range of margins.  Small margin may require unrealistic large sample size, while […]

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Tal has over 5 years of experience of consulting researchers on a variety of biomedical research including cardiology, internal medicine and infectious disease.  As a biostatistician, she is engaged in study life cycle from planning throughout the statistical analysis and up to publication.  She also took part in big-data analysis as part of evaluating Hospital databases.  Tal has served as a clinical trials’ statistician for number of studies.  She is an R programmer and has been teaching short courses of applied biostatistics with R in Tel-Aviv university and Ono Academic College.

Dina has a strong background in statistics and a high level of data analytics abilities.  She has over 5 years of experience in applied biostatistics.  Dina holds an M.A. in Biostatistics and a B.A in statistics both from the Hebrew University.

Ronit manages all of IntegiStat's administrative affairs. She has experience in office management in general and specifically in the health sciences, and is certified in accounting and law.

Diklah founded and heads IntegriStat. She has extensive experience in managing diverse data projects of all sizes. Diklah has extensive experience in providing support to companies running clinical trials to validate their product for regulatory clearance including FDA and EMA.

Her professional experience also includes: statistician at West Pennsylvania Psychiatric Institute; establishment of a statistical service at Wolfson Medical Center, Holon; lead biostatistician at a number of biotech startups.

Diklah is the author or coauthor of more than 50 scientific publications. Diklah has a B.Sc. in Statistics from University of Haifa; an M.Sc. in Biostatistics from the Graduate School of Public Health, University of Pittsburgh; a Master of Entrepreneurship and Innovation degree from ISEMI, Swinburne University of Technology; and Ph.D. in Biostatistics from Ben Gurion University of the Negev.