AT ITS BEST
Inference was founded to fill the need for quality Biostatistics and Data Management services in drug development. Our operations are anchored in our deep experience in supporting a variety of development programs at the portfolio level, as well as expertise in support of individual studies. We translate trial objectives to testable hypotheses, develop optimal study designs, and formulate best analytical strategies for reporting the data. Our understanding of the science and the ever-changing regulatory expectations worldwide is reflected in how we collect clinical data, maintain integrity of the trial, and finally how we make statistical inference. After all, accurate clinical conclusions must rest on flawless execution and reporting of the data.
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.
Good inference can only be based on good data, and collecting good data has to be planned properly and executed flawlessly. We provide end-to-end clinical data management services.
Reporting of data to regulatory agencies requires programming of standardized datasets, meaningful and validated outputs and thorough documentation for the reviewers.
Much of drug development rests on questions about dosing, safety, drug interaction, bridging of formulations and populations, and characterizing the PK profile of the molecule and its metabolites.
Inference's medical writers have years of experience in preparing ICH-compliant study documents from protocol to CSRs to integrated documents for submission.
Inference offers a Functional Service Provider (FSP) model to sponsors to augment the sponsor's team on both a short and long-term basis. Our model is flexible, cost-effective and is managed by a well-defined governance structure.