I currently provide services for non-clinical, pre-clinical, and clinical trials for the biotech and pharmaceutial communities in San Diego.  Please see below for more information regarding our services.

Independent Statistician to perform:

• Study randomization schedules;
• Sample size calculations;
• Interim analyses;
• Unblinded QC of Pharmacokinetic, Pharmacodynamic, and safety data.

Report writing and editing including:

• Statistical sections of clinical study protocols;
• Statistical analysis plans;
• Table, figure and listing shells;
• Programming specifications;
• Statistical sections of clinical study reports;
• Investigator's brochure's;
• Annual reports to the FDA;
• Journal publications.

SAS programming in support of:

• Quality control of clinical trial data;
• Customized safety monitoring reports;
• Ad-hoc analyses;
• Validation programming;
• Non-clinical and pre-clinical studies.

Providing statistical support to Data Management by reviewing:

• Data management plans;
• Data import and export agreements;
• Database setup;
• Case report forms.

Departmental support including:

• Writing standard operating procedures for statistical programming and biostatistics;
• Validation of SAS software installation including writing a validation master plan, installation qualification protocol, operational qualification protocol, and conducting the performance qualification;
• Managing work outsourced to Contract Research Organizations.