Data Strategy & Data Governance

PharmaLex’s Global Statistics and Data Science team brings together a wide range of experts – from study design and planning to statistical analysis, reporting and data management. Our experts help companies with complex innovative trial design, translational and precision medicine, pharmacometrics, and data science across the clinical journey.

In CMC statistics, GSDS has been leading the field and acted as opinion leader for the last 15 years, proposing robust and innovative statistical solutions for the development, validation, and control of processes to manufacture all types of drugs. We help our customers applying the latest guidance on processes, formulation, and assay lifecycle (e.g. FDA process validation, ICH Q1-Q14), from early development and characterization, process performance qualification (PPQ), and assay lifecycle (validation, transfer and routine manufacturing use). We have state-of-the-art expertise in Quality by Design and Analytical Quality by Design. In manufacturing sciences, we also support annual review, acceptance criteria definition, release limits and specification computations, and stability studies.

The discovery and pre-clinical development of new drug products is a growing challenge for biopharmaceutical industry. Rapid advances in technologies help to better understand the biology of a new drug product. The vast increase in data, however, increases the risk of false discoveries leading to costly mistakes. In PharmaLex our statistical experts use appropriate statistical methods to improve reproducibility and increase the efficiency of discovery and pre-clinical studies.

Advances in omics technologies bring both opportunities and challenges in understanding disease and development of novel therapeutics. In PharmaLex, our experts have over twenty years of experience in understanding omics data – genomics, transcriptomics, proteomics, and metabolomics, among others – and uncovering insights to inform discovery and development of medicines.