Biostatistics support for Medical Affairs :

Generate the data that makes your drug unique

Medical Affairs Biostatistics

Medical Affairs is a critical function in the drug development and commercialization process, as it is responsible for ensuring that scientific and medical information about a product is accurate, balanced and effectively communicated to relevant stakeholders.

This includes working with clinical researchers to design and conduct clinical trials, interacting with regulatory agencies to provide scientific and medical input during the approval process, and educating healthcare professionals about the appropriate use of the medical products.

In addition to these responsibilities, Medical Affairs also plays a key role in the post-marketing phase of a product’s lifecycle by monitoring the safety and effectiveness of the product in real-world use, responding to medical inquiries from healthcare professionals and patients, and providing ongoing medical education to ensure that the product is used appropriately.

Medical Affairs helps ensure that a company’s products are developed and marketed effectively and ethically by supporting the development of scientific and medical education materials and other communications.

At Signifience, our Biostatisticians are committed to supporting the Data Generation process in your Medical Affairs and Data Mining group.

  • We perform a wide range of post-hoc analyses of clinical trial databases, design new observational, post-marketing and other RWE studies.


  • Our extensive experience in developing statistical models to identify predictors of better clinical outcomes of new drugs helps target patients subgroups of interest and support the growth of personalized medicine.


  • We perform Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)


  • We also provide statistical expertise to support the development of medical education materials and other communications such as abstracts, posters, oral presentations for congresses and medical manuscripts.