Biostatistics

At the core we are a statistical company. Our expertise is in Statistics as it is applied to all phases of drug development. We do it deliberately, efficiently, and with passion. We focus on current regulatory frameworks, innovative designs and analytical methods. Our services span from consulting, developing statistical plans, conducting data analysis, and collaborating with the sponsor to prepare for regulatory submissions. Our other services, such as Data Management, are also informed and enhanced by our statistical outlook.

• Statistical Consulting – At the project level we can assist you in preparing a Clinical Development Plan. At the individual protocol level we can help you prepare a protocol by translating the objectives into testable hypotheses, and choosing the proper study design and analytical strategies. Our value proposition is not just in the statistical know-how, but in how we apply this knowledge in the context of regulatory expectations. We write the Statistical Analysis Plans (SAP) in great detail and well before the database-lock so that these expectations are met without issues.
• Clinical Study Report (CSR) – Since we often start at the protocol stage or earlier, and generate the statistical outputs ourselves, we take on the responsibility of reviewing the CSR to make sure that the results are presented accurately and that they lead to appropriate conclusions. We strictly follow the ICH E9 guidance so that the CSR meets the regulators’ expectations.
• Data Monitoring Committee (DMC) – We prepare DMCs by helping draft the Charter, recruiting the voting member statistician in the committee and/or supporting the committee with statistical outputs. We have also participated as a voting member of the safety committees.
• Regulatory Interaction – We are happy to defend the design and the statistical methodology we suggest in the protocol and the SAP to the regulatory bodies. We have had experience in preparing briefing books, providing written responses to the agencies, and also numerous interactions with the agencies in face-to-face meetings.

The following is a list of tasks taken up by our statistics group:

• Consulting on development plans
• Statistical input in protocols, and preparation of statistical section including sample-size detarmination
• Provide expertise on statistical designs including adaptive designs
• Preparation of Statistical Analysis Plans 
• Support safety and dose selection committees
• PK data modeling
• Preparation of Clinical Study Reports
• Data Monitoring Committee membership
• Statistical support for Data Monitoring Committees
• Preparation of submission packages including briefing books and story boards
• Regulatory interaction including face-to-face meetings with regulators
• Regulatory filing support including responding to regulatory questions