Copenhagen, Denmark, March 24th, 2020
SMART-TRIAL and DataSights announce educational webinar, How to Estimate Sample Size for Medical Device Studies to be held Wednesday, April 1st, 2020 at 15:00 CET. The webinar is dedicated to introducing the basics behind statistical methods used to calculate sample size, so medical device clinical teams can be prepared for discussions with statisticians and eventually Notified Bodies.
The webinar will be presented by Jón I. Bergsteinsson, VP of Business Development for SMART-TRIAL and Oren Bar-Ilan, the Managing Partner of DataSights, who together will be sharing valuable insights on Sample Size Determination.
The MedTech industry has been facing unprecedented challenges with the Medical Device Regulation (MDR), leaving many questions unanswered. One of the more pressing and prevalent questions is “How many subjects do I need for my study?” Many clinical teams are looking for answers to the lack of know-how and guidance on sample size estimation. Providing clinical teams with relevant guidance and knowledge to fill the gap is the underlying driver behind this webinar.
Noted industry expert Oren Bar-Ilan “Has noticed the increase in questions regarding Sample Size” he adds “I will be giving participants valuable insights to improve their understanding of the statistics behind sample size calculation to help them be better prepared for future discussions on sample size”
The MDR is forcing many MedTech companies to conduct clinical studies to gather data for Post-Market Clinical Follow-Up (PMCF) and clinical evaluation. One of the first crucial steps in designing a clinical study is determining the number of subjects to recruit i.e the study sample size.
And, to pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning.
What attendees will learn:
1.The basic inputs behind sample size calculation
2. How study design can impact sample size
3. How to prepare for a discussion on sample size with a statistician
Registration is now open, visit https://info.smart-trial.co/webinar/how-to-estimate-sample-size-for-medical-device-studies
Jón I. Bergsteinsson, M.Sc. Biomed. Eng. is the VP of Global Business Development and the co-founder of SMART-TRIAL, he also served as the CTO until 2017 where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical informatics, research, and medical devices, Jón’s primary mission is to share valuable insights and know-how on clinical data management with the MedTech industry.
Oren Bar- Ilan MA. Statistics has more than 25 years of experience in healthcare. In 1996 he founded Tmura, which provided statistical services to various industries. In 2011 Oren became the head of Global Non-Clinical Statistics for Teva Pharmaceuticals, supporting statistical aspects of early development and Ph-I clinical studies of Teva’s branded products. In 2018 Oren co-founded DataSights, which provides statistical services to pharma, medical devices, biotech AI, and Cannabis.
SMART-TRIAL is helping MedTech clinical teams to comply with regulations on clinical evidence, by simplifying the collection and management of data. Tailor-made for MedTech, SMART-TRIAL offers a do-it-yourself Electronic Data Capture for clinical investigations and PMCF activities, including registries and surveys. SMART-TRIAL is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance. For more information visit: www.smart-trial.co
With the motto from Data to Insights, the company provides statistical consultancy and training services. DataSights focuses on the pharmaceutical and medical device industry. Their scientific and business orientation brings a unique perspective. It allows us to raise questions that sharpen the scientific questions of interest and address problems in a proactive manner. Their expertise spans from non-clinical to clinical studies on small molecules, biologics and medical devices at all phases and in multiple therapeutic areas. For more information visit: www.datasights.co.il
Erika Michelle Pinto
Phone: +45 53824546
Email: [email protected]