It's a fact of clinical research that assumptions for the test statistic specified in the protocol can be thwarted by oddly distributed data caused by hidden factors and outliers. To overcome the challenges of deviant data, Pharm-Olam has responded with innovative alternatives to traditional statistical analysis.

Often, Assumption Driven Innovative Data Analysis (ADIDA) leads to the use of an accepted alternative method available in our proprietary mixture analysis software. Through mixture analysis, we have successfully proven a drug’s efficacy and safety and securing regulatory approval in cases where standard techniques would have led to failure. Pharm-Olam offers a full range of biostatistics services, from basic statistical analyses to complete, high-level advisory services working with regulatory agencies in collaboration with your own team.

Mixture Analysis Filters Out Data Noise. High levels of noise or variability in the clinical data produces a contaminated distribution, contrary to the classic bell curve. The robust methodology of our mixture analysis software explains excessive noise and provides the best chance to demonstrate that a drug is effective and safe. It also offers increased clinical insight through classification of subjects into subgroups including a patient by patient analysis.
We use mixture analysis to analyze continuous measurement data, such as blood pressure, depression scores and exercise tolerance time for Phase I to Phase IV studies of all sizes, including survival and health outcomes studies. Mixture analysis can also identify new indications through analysis of safety data.

Our Success Stories of using Mixture Analysis

• Analysis of Phase I hypothyroidism study showed generics were not comparable
• Analysis of Phase IV cardiovascular study showed test treatment more effective than standard after accounting for hidden structure
• Analysis of efficacy data for CNS and cardiovascular NDAs leading directly to FDA approval
• Analysis of safety data for an obesity drug contributed to FDA approval
• Analysis of allergic rhinitis study with site and rater differences confirmed efficacy