Clinical Biostatistics

Pre-Clinical Biostatistics

Axio was founded by an internationally recognized group of biostatisticians and epidemiologists, many of whom remain closely involved with the company. Axio has become recognized as a premier provider of biostatistics services to pharmaceutical and healthcare providers. This recognition is the result of our Ph.D. and Masters biostatisticians experience which is both deep and wide.

The depth of that experience is reflected not only in years of experience (averaging 10 years) but also in therapeutic area expertise including oncology, neurology, cardiology, immunologic indications, and blood products.

Our experience ranges across Phases I-IV, investigator-initiated studies, data monitoring committee support, and meta-analyses. In addition, our clients represent the spectrum of very small to very large pharmaceutical, biotechnology and medical device companies, as well as the NIH and academic researchers.

Clinical Trial Design

Axio biostatisticians have extensive experience assisting companies with clinical trial design and analysis for FDA and European regulatory submissions. Our capabilities include:

• Sample size calculation, and development of interim monitoring plans and statistical analysis plans;
• Statistical analysis and reporting for Phase I-IV Clinical Trials;
• SAS and S-Plus programming; and
• Custom reporting.

Data Analysis and Biostatistics Consulting

Axio biostatisticians are called upon to perform a wide variety of analyses which include reconfirming statistical results for use in peer reviewed publications, meta-analyses and derivation of complex computed variables in clinical and preclinical settings. Our capabilities include:

• Merging disparate datasets, creation of analysis datasets and derivation of complex computed variables;
• Aherence to FDA analysis and documentation standards (e.g. all programming is independently verified and tested by a second programmer); and
• Previously Developed SAS macros for rapid turnaround of standard statistical tables.

Axio has biostatisticians on staff that can advise on and develop a statistical analysis plan that is right for your unique study or compound. Our biostatisticians have experience with parametric and non-parametric statistical analyses in the full range pre-clinical studies including toxicology, telemetry and repro-toxicology.

Axio prides itself on the speed of our report turnaround; the accuracy of our reports; and the quality of the data and reports that are returned to our clients. For instance, Axio typically produces reports within 2-4 weeks of data receipt. Our statistics are produced in SAS and are independently validated. Our Quality Assurance is on-site and trained in GLP, GCP, OECD and MHLW regulations.

Our services include:

• Assistance with IND submission packages
• Statistical Analysis Plan Advising and Protocol Development;
• Statistical Tables in a clear, easy-to-read format;
• Data Listings;
• Data Quality Assessment; and
• Report Assembly including statistical methods results and descriptions.