Statistical Consultancy

Quanticate is vastly experienced in providing consultancy for both short and long term projects in a wide variety of therapeutic areas. Our consultants have many years of expertise in their speciality. We excel in providing the right people for your projects, understanding that matching skill sets to customer requirements is key to success.

Study Design

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.

Adaptive Design

Over the years many Adaptive Design and Bayesian methodologies have become widely used, but choosing the right ones at the right time is crucial to placing control over research programs at all stages of development. Quanticate consultants can help dispel some “myths” and advise on the advantages and disadvantages of the different study designs that you may be considering. Well planned designs ensure the best project go/no go decisions and lead to the earliest possible technical and regulatory success.

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]

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.

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