Investment decision making in the biotech industry is strengthened by estimating the likelihood of success of drugs in a company’s pipeline.  A comprehensive and in depth statistical analysis of a company’s Phase II and III clinical trials can often provide an assessment of that likelihood and help quantify risk.
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• Written evaluation of the strengths and weaknesses of a drug trial’s experimental design and statistical analysis plan;
• Calculation of power and P values for ranges of treatment and placebo effects to predict the likelihood a trial will be successful;
• Conference calls with you and the drug company’s scientific and biostatistical team to clarify issues related to the trial design and analysis plans;
• Meta-analyses summarizing the prior pre-clinical and clinical data used in developing a new drug application for the FDA to determine how well prior data supports the claims of a company;
• Peer-review level analysis of prior publications, released data and results from drug trials, medical conference presentations, and company press releases.

BioRankings can provide the same in-depth clinical trial data and structure analysis that we provide to investors as an expert witness to class-action lawsuits. We can provide:

• An evaluation of the strength and weakness in a clinical trial design, which could uncover flaws in the nature of the study which could skew data and results; 
• The calculation of power and P values to show the likelihood the trial would have any success, which could provide insight into whether or not the drug ever had a chance of success by its own merits;
• Meta-analyses summarizing the pre-clinical and clinical data used in developing the drug for its FDA review which can show how prior data supports or refutes company claims.

Our focus is coming up with innovative ways to deal with the complex statistical problems posed in today’s technology-rich information age. We have  developed platform methodologies and published in such areas  as comparative effectiveness research (CER), actigraphy, and human microbiome research. We continue to work in these areas in an academic capacity and are continually developing new methods and novel approaches, staying on the cutting-edge.

We can help develop the analytical model for your company by applying our statistical expertise and business knowledge. We can work with you or independently to develop the best methods for collecting and analyzing data from all levels of your operation.

For Biotechnology companies we can design the most powerful and cost-efficient experimental designs to maximize R&D dollars, and apply the optimal statistical analyses to extract the maximum amount of information from the given data. We present our findings clear and accurate meta analyses and data summaries that are comprehensive but understandable enough for use in presentations to investors, potential partners, or regulators.