Who We Are
The GCE Biostatistics team offers a range of services with quality that is derived from decades of experience and industry associations. Our experts have an average of over 18 years of experience covering:
- All Phases of clinical trials and publications
- All types of submission (IND, NDA, sNDA, PMA, 510k etc.) for all of the major regulatory agencies (FDA, EMEA, PMDA)
- A wide range of therapeutic areas including Oncology, Neuroscience, Cardiovascular, Respiratory, Infectious Disease, Immunology/Vaccines, Analgesics, Ophthalmology
- Diverse statistical methodologies including Bayesian, multiple imputations, simulations, mixed effects, survival analyses, and multiple comparisons
- Diverse experience in trial designs including parallel, crossover, adaptive, observational, non-inferiority, and group sequential
What We Provide
Our broad range of services include:
- Protocol development
- Clinical study design and sample size determination
- Creation of Statistical Analysis Plans (SAP) including mock-shell development
- Statistical oversight of clinical dataset development (e.g. SDTM and ADaM)
- Producing/validating randomization schedules
- Statistical oversite of tables, figures, and listing development
- Perform exploratory analyses
- Function as the blinded or unblinded DMC statistician
- Publication support
GCE has been implementing statistical tasks for clinical development from an array of pharmaceutical, biotechnology, and medical device companies since 2007. We have preserved statistical innovation over the years by requiring our professionals to continually hone their clinical and technical knowledge and expertise.
Our team offers unique and conceptual solutions by leveraging team member diverse professional accomplishments as statisticians at pharmaceutical companies, full-time or adjunct professors at universities, and in statistical leadership positions. With multiple end point and various experimental design involvements, this group brings knowledge and a deep understanding of the sciences of disease and compounds.
At GCE, our team is a group of selectively hand-picked professional(s). We work closely with our clients to understand their specific needs so that we can align the experience of our allocated team to match the requirements of the project. Additionally, our professional(s) are typically solely dedicated to a single client for the life of the project so their focus can ensure success.
Our team has been a regular contributor to the industry groups including ASA (American Statistical Association), PhUSE, and PharmaSUG.
For More info: Refer to the Why GCE? page for more reasons to choose GCE for your project!