Biostatistics

• Full Support for Phase I-IV clinical trials Study design and consultation. Our experienced statisticians are committed to providing you with optimal clinical trial study designs to meet both regulatory and promotional needs.

• Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, clinical development, evaluation/approval, manufacturing, and marketing research.

• Regulatory Assistance in presenting statistical methods before regulatory authorities.

• Protocol Development and verification of CRF design to ensure that data is collected in a manner to facilitate optimal statistical methods.

• Randomization – Our statisticians consult and generate randomization schemes to meet your study requirements using an array of methods. Whether you require blinded envelope system, an interactive phone/web randomization system, or a simple unblinded open random schedule these are constructed in a highly controlled and secure environment.

• Statistical Analysis Plan development – In concert with your focus and requirements, our expert statisticians provide a detailed analysis plan highlighting the methods and derivations in an a priori fashion.

• Statistical Programming support for all phases of clinical trials. Our team of highly qualified and experienced statistical programmers provide all statistical output required according the statistical analysis plan and ad hoc requests.

• Interim analysis and DSMB – Ockham provides full statistical and programming support for interim analyses and/or data safety monitoring boards in either a fully blinded or unblinded manner, depending on study requirements.

• Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for NDA Submissions. Our statisticians and statistical programmers are well versed and experienced in providing critical statistical and programming support for NDA’s and sNDA’s.