Services we offer and specialize in

Advising on clinical study designs and appropriate statistical analysis methods
Developing and reviewing clinical study protocols, statistical analysis plans, study reports, and sections of the NDA/BLA
Writing and reviewing statistical sections of study reports, manuscripts, abstracts, and scientific presentations
Assisting in due diligence assessment in business development opportunities
Preparing for and participating in meetings with regulatory agencies
Serving on data monitoring committees for clinical trials
Serving on mock panel of regulatory meetings
Providing biometrics department management and infrastructure consultations
Assisting in data management and statistics CRO vendor qualification
Giving short-series lectures in biostatistics

Developing and advising on COA measurement strategies for clinical trials
Developing novel composite endpoints from item libraries that are tailored to individual trials
Advising on electronic implementation of COA strategies in clinical trials
Advising on analysis methods of COA data in line with FDA Patient-Focused Drug Development Guidance Series
Developing and reviewing COA sections of clinical study protocols, statistical analysis plans, study reports, regulatory documents, and HTA/reimbursement submissions
Developing and reviewing patient/clinician interview guides

Conducting statistical analyses and generate tables, listings, and figures for clinical study reports or manuscripts
Creating CDISC compliant datasets, especially for SDTM and ADaM models
Performing independent validation of statistical analyses or dataset creations
Provide statistical programming support for COA dossiers