Planning for a clinical trial? Mitigate trial risk and increase efficiency with robust statistical planning — partner with us.
We offer statistical planning and regulatory support for early- and late-phase clinical trials and observational studies, with expertise in Adaptive Designs including Bayesian Designs, as well as the application of machine learning for biomarker discoveries and diagnostic device development. In addition to design and analysis, we offer support in regulatory defense for clinical trial designs and protocols, and Data Monitoring Committee (DMC) related services. While we cover all therapeutic areas, we have extensive experience in Oncology, CVD, CNS, rare diseases, vaccine trials and medical devices. We are also actively involved in developing cutting-edge statistical tools and software to empower statisticians, data scientists and clinicians.
MuSigmas has experience in a wide array of topics in the field of clinical trials. From design of studies to monitoring and analysing them, from statistical programming to developing custom software, MuSigmas is the right partner for your clinical trial needs.
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MuSigmas partners with top life sciences organizations to deliver open-source solutions in R and Python, deploy Statistical Computing Environments (SCEs) on cloud-native platforms, and support SAS-to-R migration for faster, data-driven decision-making in regulated settings.
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With over 25 years of experience in biostatistical consulting and statistical software development, we have developed deep expertise in solving statistical problems arising across therapeutic areas, phases of development, endpoint and design complexities, regulatory needs and their evolution, advancement in technology and risk and operational barriers that can hamper the chance of ultimately bringing a beneficial therapy to the patients.
Our frequent discussions and collaborations with both regulators and sponsors give us a clear understanding of operational barriers, risk factors for pipeline failures, regulatory pathways and expectations. This enables us to help sponsors design trials that are risk-mitigated, efficient and robust while meeting regulatory and payers’ standards effectively.
We continuously stay abreast of advances in mathematics, bio-statistics, machine learning, computing and technology. This ensures that our statistical strategies for clinical trials or pipelines use the most relevant and optimal methodologies while allowing the most efficient use of data for decision making. Our strong publication record demonstrates both our technical depth and our commitment to innovation in our areas of expertise and interest.
We are a focused team specializing in biostatistics consulting. Our small size allows us to work in complete synchrony with our clients, offering real-time support and collaboration.
Beyond trial design, monitoring and analysis, we assist clients in aligning clinical development and investment strategies and support them in communications with investors, regulatory authorities and payers.
Our support, when engaged early in the planning stages of a clinical trial or pipeline, can reduce time to market and/or overall costs (such as sample size) while increasing the probability of success.
A Case Study on Overcoming Recruitment Challenges Through Innovative Trial Design. Learn how we helped a sponsor reduce trial duration by 6-12 months while maintaining statistical rigor.
Partner with MuSigmas to leverage cutting-edge statistical methodologies and accelerate your drug development timeline. Our expert team is ready to help you achieve breakthrough results.
