High quality, efficient, and customized statistical analysis of clinical trials.
An experienced and versatile team for your biostatistics and statistical programming needs.
Emanate Biostats specializes in providing customized biostatistical services for clients developing drugs, biologics, and devices. Statistical expertise includes trial design, data analysis, reporting for DMCs, and CDISC-compliant conversion. Our experience, industry savviness, and efficiency enable us to provide innovative solutions and personalized services for our clients that large CROs cannot.
Experience
Founded by three accomplished industry experts, we have considerable experience with statistical study design and analysis of oncology and rare disease trials as well as a vast array of other therapeutic areas. We can support interactions with regulatory authorities including submissions for NDAs, BLAs, ISS, and ISE. We have an expert understanding of CDISC compliance guidelines for SDTM, ADaM, and metadata submission files and have developed proprietary tools for efficient conversion of a clinical database to a CDISC-compliant submission package.
Why Us?
We are experienced and accomplished industry veterans. Our small yet experienced roster enables us to adapt to a client’s specific needs, respond immediately to critical requests, and develop process efficiencies. We also provide an array of novelty services in addition to standard biostatistical and CDISC capabilities.
Target Market.
Our clients are small and emerging biopharmaceutical and biotechnology companies with limited in-house statistical resources. Our clients have a particular interest in exploration of the statistical results for their clinical trials and are intimately involved in the development and review of their statistical deliverables.
Our Solutions.
We provide innovative biostatistical and programming solutions, including the highest quality CDISC and CSR-ready statistical analysis outputs for clinical trials. We offer standard biostatistical services for clinical trials and integrated submission programs, as well as general biostatistics and statistical programming consulting.