Biostatistics and programming service in clinical trials design (Phase I-III), data analysis, and clinical report review for both drug development and molecular diagnostic projects
Data mining, visualization and reporting using cutting edge techniques including machine learning
Strategic planning for new products from inception through development, commercialization, publication support, and lifecycle management
Technical evaluation in biopharmaceuticals, vaccines, molecular diagnostics, and technologies, including due diligence for venture investments and M&A.
Our team members are leading experts in data sciences (biostatistics, bioinformatics, machine learning and deep learning) and product development.
Oncology, Hematology, Infectious Disease, Genetic Disease (Pre-/post-natal), and Rare Diseases
Extensive experiences with FDA (CDRH/CBER/CDER), CMS/CLIA/NYSDOH, Health Canada, EMA and Asian regulatory agencies including CFDA.
Bioinformatics, pre-clinical discovery, biomarker application, early and late phases clinical programs, product development and commercialization, and publication planning.
Extensive publications in peer-reviewed medical and scientific journals. Co-inventor of patents in technology platforms, molecular diagnostics and drug development.
Leadership positions in American Statistical Association (ASA), International Chinese Statistical Association (ICSA), Society of Clinical Trials (SCT) and Drug Information Association (DIA).
CDISC Standards, SAS programming, R/perl/python/Java/C++ programming
Our team members are highly educated and all possessed terminal degrees (Ph.D.) in the field
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