We provide protocol development activities with input into the design considerations, statistical methodology to be used as well as the sample size estimation. We will simulate the likely outcomes of the study under different scenarios.
Have you been considering an Adaptive Design for your clinical program? This is one of the hot topics being discussed in the industry at the moment. We can help dispel the “myths“ and advise on the advantages and disadvantages of the different types of adaptive design that you may be considering. One of the success factors to Adaptive Designs is careful planning. We help support these activities utilizing our own experience.
Support for Regulatory Activities
We offer statistical consultants to provide support to regulatory activities such as input into regulatory documents, attendance and input at regulatory meetings and review of regulatory materials. We advise on the appropriate structure of integrated summaries and support all post-approval activities.
Data Safety Monitoring Boards [DSMBs]
Several of our consultants have been involved with DSMBs – either as independent or DSMB statisticians. It is vital to the success of DSMBs that the independent statistician is knowledgeable of study design, the data and any bias considerations to facilitate the DSMB review process.