Driving Success from Discovery to Commercialization
Throughout the BioPharma industry, many think statistics are critical only to human clinical trials. However, Non-Clinical Statistics plays a pivotal role in moving assets through discovery, research, and development—all the way to commercialization. Though lesser known, these specialized statisticians are essential to ensuring that every aspect of a drug’s journey from lab bench to market is grounded in rigorous, data-driven decision-making.
The Power of Non-Clinical Statistics
At RCH Solutions, there is a keen awareness that drug development is a complex, high-stakes process. Success rates hover around 7-8%1, and setbacks in the early development or manufacturing stages can result in costly delays. A skilled non-clinical statistician can distinguish between a program that stalls and moves forward confidently. Non-clinical statisticians specialize in addressing challenges that arise long before clinical trials begin. They support diverse teams across Discovery, Research, and Chemistry, Manufacturing, and Controls (CMC), ensuring your program is designed to answer the right questions from the outset.
Early-Stage Impact: Target Identification and Method Development
Designing the suitable experiments in the early stages of drug discovery is critical. Non-clinical statisticians help BioPharma organizations by guiding the setup of studies that provide reliable, actionable data. Whether designing NGS studies to identify targets or working with chemists to optimize analytical methods, non-clinical statisticians help ensure that your data answers the questions that matter.
With proper statistical guidance, teams could save time and resources by quantifying value and avoiding chasing the wrong or inconclusive outcomes. A non-clinical statistician helps to mitigate this risk, maximizing the value of your early-stage research and putting you on the path to success.
Optimizing Manufacturing Processes and Ensuring Quality
Regarding manufacturing, non-clinical statisticians are critical players in developing robust process understanding and product characterization. They collaborate with engineers and chemists to design experiments that optimize processes, minimize variation, and consistently produce high-quality products.
Statistical methods can also be applied to issues like impurity reduction, process transfer to Contract Manufacturing Organizations (CMOs), or method validation—tasks vital to smooth regulatory submission and approval. In this way, Non-Clinical Statistics mitigate risk and keep the drug development pipeline moving forward.
Bridging the Gap Between Science and Regulation
Regulatory submissions can be a significant hurdle in getting a product to market. A well-designed statistical plan can help address concerns from agencies regarding impurities, method validation, or product stability. Non-clinical statisticians, equipped with the ability to model complex scenarios and collaborate with scientific teams, play a critical role in ensuring the readiness of an asset for regulatory approval.
Their expertise enables your team to present data compellingly and scientifically soundly, meeting the rigorous expectations of regulatory bodies. From INDs to BLAs and NDAs, they ensure your program’s foundation is built on solid, data-driven decisions.
Partnering with RCH Solutions: The Non-Clinical Statistics Advantage
At RCH Solutions, we understand Non-Clinical Statistics critical role in BioPharma’s success. Our team of expert statisticians works collaboratively with your R&D and CMC teams to ensure programs are designed for optimal outcomes, not bottlenecks. From target selection to regulatory approval, we deliver data-driven insights that save time and resources, minimizing trial and error. By leveraging our expertise, you can streamline processes, enhance production, and confidently move your drug development program forward—ultimately bringing life-changing medicines to patients faster.
Get in touch with our team of expert statisticians today to learn more about our Non-Clinical Statistics services.
1 Source: Biotechnology Innovation Organization (BIO), Informa, QLS Advisors, Clinical Development Success Rates 2011-2020.