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 

• 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