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.
Contact our specialists to tailor a service plan
The importance of statistics in discovery and pre-clinical studies
At PharmaLex, our experts of statistics are experienced in helping sponsors to improve the probability of success in discovery and pre-clinical studies, which in turn can benefit further clinical development. Besides applying advanced statistical modeling and machine learning to drug target discovery and lead optimization, our statisticians also have expertise in study and experimental designs, improving the reproducibility of conclusions. In addition, we are experienced in supporting sponsors in their animal studies under the Animal Rule to move experimental medical products toward regulatory approval when human efficacy studies are not ethical or feasible.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Improving reproducibility in discovery and pre-clinical studies
The statistics and data science expertise at PharmaLex helps to extract the relevant information using optimized signal processing methods and reduce the rate of false discovery by means of tailored design of experiments and advanced statistical inference. Second, as regularly mentioned in the scientific literature, pre-clinical studies suffer from a lack of reproducibility. Here again our experience in statistics contributes considerably to improve the reproducibility of conclusions with innovative design of experiments and new analytical strategies. Third, given there are several drug products that are potential candidates, PharmaLex experts propose to de-risk the decision-making process using Bayesian statistics to evaluate the predictive probability of success and supporting optimal portfolio management. Indeed, what matters most is to evaluate the chance for a potential drug product to succeed instead of examining if a past study was successful or not.
Animal models and medical countermeasures
According to FDA’s website, “medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease”. Sponsors need to show evidence that demonstrates effectiveness of a medical product before it can be approved by FDA. When human efficacy studies are not ethical or feasible, the Animal Rule may be considered to use results of well-controlled animal studies in establishing the product is reasonably likely to produce clinical benefit in humans. PharmaLex is experienced in providing statistical advice and analysis in such animal studies.
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.More Info
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.More Info
Omics Data Science
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.More Info
Complete this form to stay in contact with us.
PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.