Yana Dutt-Singkh is an experienced MD Obstetrician and Gynecologist/Pediatrician-nephrologist, and Senior Clinical Research Specialist with a total of 18 years of experience in conducting multi-site clinical trials for different therapeutic applications. She has led and designed clinical trials from start-up to completion for medical devices and drugs. Yana has in-depth knowledge and experience of all stages of clinical trials from designing, planning, executing and reviewing and reporting of results. Her understanding of International Regulatory Authority requirements and hands-on experience of executing multiple IRB submissions (Central, local), revision, IND, IDE, PMA, HUD submissions, safety data coding systems and reporting AEs and SAEs in medical pediatric device/drug product, makes her an expert in her field. She possesses excellent knowledge of ICH, GCP, GMP, GLP, FDA regulations, guidelines, ISO and compliance for novel product development.

Yana boasts experience in direct interactions with the FDA, EMEA, EMA and other regulatory agencies. Her successful 510K, PMA, IDE, IND submissions resulted in publications and national/international presentations. Yana has developed risk-based monitoring strategies for clinical trials, generated data to support successfully rare disease, orphan drug, breakthrough therapy designation submissions and NIH, OOPD grant applications. She has also managed budgets for different multi-and single-center studies. Yana is an inclusive team collaborator, manager, and is strongly goal-oriented and dedicated. She has great complex adaptive leadership skills with high emotional intelligence values, which has helped her developed great work relationships with Project Key Leaders, Sponsors and CROs. She has even mentored and supervised CRAs and junior associates.

Yana Dutt-Singkh studied extensively, including a Master of Science - MS, Regulatory Affairs at The George Washington University. She also studied Ordinatura, MD, Specialization in Pediatrics Nephrology, Residency in Ultrasonography, Doctor of Medicine, Obstetrics and Gynecology, Residency in Obstetrics and Gynecology at AARSI MEDICARE HOSPITAL, Internship in Pediatrics and MBBS, Doctor of Medicine, Pediatrics at IRKUTSK MEDICAL UNIVERSITY.