A strategic approach to planning, execution, and analysis that puts feasibility and meaningful interpretation at the center of every decision.
Achieve scientific and operational alignment with Firma’s complex-capable biostatistics team. Firma delivers clean data and enables faster submissions for traditional, straightforward studies, and can successfully advise on how best to tackle nontraditional studies.
Firma’s biostats leaders have in-depth industry knowledge across all aspects of global drug and medical device development and have provided expert guidance to more than 700 study teams.
Decades of interactions with global regulatory bodies form the foundation of Firma’s approach to biostatistics so strategic recommendations and analyses always keep regulatory approval in mind.
Decentralized, adaptive, and complex innovative trial designs (CID) and other nontraditional study designs require an innovative approach to analysis that still preserves data integrity. Firma applies advanced data analysis as appropriate.
Firma’s biostats team members are expert interpreters, translating clinical interest questions into statistical questions, choosing the appropriate analysis, and presenting results in a way that is meaningful for non-biostats stakeholders.
Advanced data analysis and innovative methodologies are our specialties. But we do standard, too. Our biostatistics team includes PhD- and MS-level professionals as well as statisticians with medical degrees. Our summary analyses always make sense, and our deliverables are meaningful and submission ready.
Find out how Firma uses a lifecycle approach and why it is key to delivering a compelling, easily understood data story to the FDA for rapid approval and accurate labeling.