Miklos L. Schulz, PhD.
Chief Executive Officer and Senior Consultant
Dr Schulz’s professional career began at Chinoin, a European pharmaceutical company where his interest in the design and analysis of clinical trials evolved.
His PhD thesis on individualised optimal drug therapy in diabetes mellitus was based on his work collaborations with leading research groups at the Semmelweis University Clinical (Budapest, Hungary) and the Hospital for Sick Children (Toronto, Canada).
Following his post-graduate work, Dr Schulz worked at the Hospital for Sick Children in Toronto, Ontario Canada as a Senior Scientist conducting investigations in intermediary metabolism and diabetes, as well as designing and analysing clinical studies.
In 1986, Dr. Schulz established SCiAN Services, Inc., a Contract Research Organization (CRO) that provides clinical data management (CDM), Biostatistics and custom database solutions services to the Biotechnology and Pharmaceutical Industries.
In 1997, anticipating the impact of electronic data capture (EDC) for clinical trials, he co-developed EDCPRO, SCiAN’s proprietary EDC system. Today, EDCPRO is the corner stone of SCiAN’s Clinical Trial Data Centre (CTDC) which includes complementary modules for Trial Master Files (TMFPRO), Serious Adverse Event Management (SAEPRO) and Integrated Summary of Safety/Efficacy (ISEPRO).
Dr. Schulz continues to be active in clinical drug development, often consulting to small biotechnology and biopharma companies in their clinical development program planning and representing Sponsors at regulatory agency meetings. He has some 35 publications to his credit in applied statistics and pharmacokinetics for various therapeutic fields. He has a keen interest in study design methodologies with a particular focus in sequential and adaptive designs.
St. Clare Chung, MMath
Vice-President, Biostatistics & CDM
St. Clare Chung has a Bachelor’s Degree in Mathematics (York University) and a Master’s Degree in Statistics (University of Waterloo).
She joined SCiAN in 1992 as a Statistician and is currently its Vice President – Biostatistics & CDM. Her statistical expertise includes the design, analysis and reporting of Phase I-IV clinical studies in Oncology, CNS, Diabetes and Dermatology. St. Clare has extensive programming experience in SAS and Lotus Notes and was a key member in the design and implementation of SCiAN’s list of proprietary electronic database solutions including: EDCPRO, SAEPRO and ISEPRO.
St. Clare has presented at several conferences including SCDM, DIA and SAS Global and has provided statistical support for Sponsor’s manuscripts and journal publications in CNS and Oncology.