We assist our clients on the design and analysis of Phase I-IV clinical trials for the filing of New Drug Applications. Areas of expertise in clinical trial design include methods for randomization, sample size determination, study design, and planned methods of analysis. We have developed comprehensive templates to assist our clients in developing and writing protocols and statistical analysis plans (SAPs), and report writing of planned clinical trials in support of licensure. We have served as the client’s statistical representative at review meetings with the Food and Drug Administration (FDA) and other regulatory agencies.
We serve as a low cost contract research organization (CRO) that offers data management activities, SAS programming and data analyses to create tables, listings, and graphs (TLG) according to the SAP. We have working knowledge of CDISC processes and procedures, produce CDISC compliant analysis datasets (ADaM), and oversee STDM data conversion. We participate in developing case report forms (CRFs), data review guidelines and edit check specs.