It’s well-accepted that unintentional unblinding during clinical trials can have serious ramifications for data integrity. But what’s not as commonly recognized is how data itself can be the catalyst for unblinding, especially during transfers.
For example, the provision of an unscrambled randomization number could reveal block size, treatment forcing, or a patient replacement.
In this webinar, Calyx’s Malcolm Morrissey and Maarit Kelvin Korpos review other scenarios of how study data can lead to unintentional unblinding and the processes sponsors and their IRT solution providers should follow to mitigate these risks.
July 17, 2023 | 10:0 am ET
After a brief presentation, Malcolm and Maarit open the floor to your questions – ask them anything!
Associate Director, Statistics and Product Support Services, Calyx
Malcolm Morrissey obtained a PhD in Statistical Inference in 2001 and since has had broad experience as a research associate, statistician, and manager in the pharmaceutical industry. He joined Calyx in 2005 and currently manages a team whose duties include supporting and developing randomization and medication management algorithms for clinical trials managed by IRT.
Maarit Kelvin Korpos
Associate Director, Project & Program Management
Maarit brings 23 years’ experience in the clinical research & pharmaceutical industry, including as a registered nurse. She currently manages a team of US-based IRT Project Managers, as an Associate Director of IRT Project & Program Management, a department she has been with for 14 years.