Regulatory Strategy

Dr. Harris graduated from Loyola University Chicago Stritch School of Medicine and holds a bachelor’s of science in biology also from Loyola University Chicago.

She has over four years of experience conducting clinical research in the medical field and has contributed to the publication of many clinical papers.

Ciara Rojas-Pate is head of communications and provides medical writing support.

She graduated from the University of Missouri – Kansas City in May 2021 with a bachelor’s degree in communications with an emphasis in mass communications and journalism. Ciara has four years of experience writing for a news publication and two years of experience as a digital media editor, working with SEO, brand enhancement, and brand marketing.

Ciara also has three years of experience working as the lead copywriter for a marketing agency, building brands, optimizing websites, distributing ad campaigns, and more.

She is particularly skilled in social media management, website building, and campaign ideation.

Rick is the head of finance and co-founder of InCSD. He holds a bachelor’s degree in business management and an MBA with a focus in data analytics from the University of Missouri-Kansas City.

He has a strong background in data analytics, R and SAS programming as well as process improvement. Rick served in the US Army for 10 years, working in an engineering battalion and later in a military intelligence company. Additionally, he has experience as a senior quality supervisor in the purchased product organization for Honeywell FM&T.

Luis is the vice president, head of biometrics and co-founder of InCSD. He graduated from the University of Delaware with a master’s of science in applied statistics and holds a bachelor’s degree in psychology from Loyola University of Chicago.

With over 5 years of experience in clinical research and biostatistics, Luis has led various Phase I to III clinical trials and medical device studies as both a blinded and unblinded biostatistician. He has proficient skills in protocol and SAP development for randomized double-blind and open-label clinical trials and has supported several DMC’s and interim analyses.

Luis has worked in various therapeutic areas, including rare diseases, autoimmune, cardiovascular, endocrine, neuromuscular, and sleep disorders.

Dr. Luis Rojas is a senior research scientist statistician with approximately 35 years of experience that spans the pharmaceutical, CRO, academic and medical device industries.

He is a subject matter expert in advanced analytics, bioequivalence, data monitoring committees, interim analysis, master protocols, regulatory agency reporting, RWD/RWE and study design.

He holds a Ph.D. in biostatistics from the Rafael Belloso University in Venezuela.  Dr. Rojas is a member of the American Statistical Association, The Sigma Xi Scientific Research Society, and the DIA Adaptive Design Scientific Working Group. He has published several papers and presented numerous times worldwide on topics associated with rare diseases, adaptive designs, RWE/RWD, the estimated, and other clinical research and biostatistics topics.