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Statistics and Data Science Service
The Global Statistics and Data Science (GSDS) team at PharmaLex delivers analytical support for the development of medical products–from early research through pre-clinical to late phase studies, plus manufacturing and health economics. We support our clients every step of the way–from discovery and non-clinical requirements to early strategic planning, clinical development, CMC development, regulatory submissions and post-approval/post-launch maintenance. Within scientific and statistical contexts, we offer interpretation, answers and data science solutions that help you make the best decisions for your business.
By partnering with our clients and working as a team, we make each other stronger. We have nurtured long term relationships with many of our clients and look forward to forging strong partnerships with many new ones.
By embracing the power of teamwork, we alleviate your short-term work overload, provide niche expertise and become your trusted go-to for all complex data analytics needs.
Without a doubt, our employees are an invaluable asset. This group of (Bayesian) statisticians, data scientists, computational biologists, statistical geneticists, epidemiologists, bioengineers, pharmacists, and programmers offers an outstanding level of skill and expertise.
Stretching across many diseases, our combined experience supports both target identification and the development of drugs, biologics and medical devices at every phase.
PharmaLex is recognized as a global leader in the application of Bayesian methodology, biomarker statistics and CMC statistics. Many of our scientists have wet-lab experience which helps them tackle challenges in biological data. We speak and operate in many languages, including SAS, R, STAN, JAGS and Python. Our deep regulatory experience also helps you navigate all statistical facets of study design and regulatory strategy.
With recent advances in science and research methodologies, the sheer volume of information at hand has increased the importance of statistics and data science.
Applied correctly, statistics and data science can help:
- Identify or validate new drug targets by means of statistical genomics, bioinformatics and computational biology techniques
- Inform better decisions in clinical development (e.g. more efficient trial design, improved patient profiles)
- Apply prior knowledge of Bayesian statistics to reduce future costs and save time
- Realize the promise of precision medicine through biomarkers and diagnostics
- Lead to safer, more-robust manufacturing by using the quality-by-design concept
- Unlock data insights by using advanced methods like artificial intelligence and machine learning
- Progress the digitalization of the pharmaceutical industry
Proven Expertise from Discovery to Post Marketing
From drug target discovery to launch and post launch activities, developing a new medical product generates vast amounts of data that need to be processed, analyzed and interpreted.
Whether for a drug, biologic or medical device, PharmaLex statisticians and data scientists have years of experience turning all that data into useful knowledge.
We can help you choose the best strategy for identifying the right drug target and de-risk the decision-making process by using Bayesian statistics to evaluate the probability of success.
Throughout clinical development, our team supports the design, strategy and full analysis of clinical trials. Should you need to include clinical biomarkers, our design and analytical expertise will guide you to success.
Based on our analytical and regulatory proficiency, we also guarantee the seamless development and implementation of any analytical procedures and manufacturing processes.