Services
SAS Programming
De Novo Consulting can program tables, listings and figures for one-off data presentations, a SAP, IDMC, or integrated summary's worth of outputs, and anything in between. We can also serve as the production or QC side of the double-programming process.
CDISC Compliant Dataset Production and QC
We have considerable experience in production and QC of datasets to CDISC standards from raw data that may or may not have been collected following CDASH rules. We can ensure your database is CDISC-compliant, including generation of the define.xml documentation, thus maximising the chances of a smooth submission to regulators using in-house macros and the Pinnacle 21 software.
Biostatistics and Data Analysis
De Novo Consulting offers fully-qualified biostatistics services, with lead statistician experience across over 20 studies in a variety of therapeutic areas and phases. We can perform exploratory data analysis on your database and help you answer the questions you may have using a hypothesis framework, with minimisation of bias and subsequently potent and effective conclusions that you can build on.
Regulatory Submission Activities
We have worked on behalf of pharmaceutical companies of all sizes to respond to regulatory questions as part of the advisory committee, submission and day 120 update processes. We have multiple interactions with the FDA, EMA, PMDA and others.
SAS Training and Mentorship
Do you have members of your team that are embarking on their first foray into the world of SAS programming? We can assist with hands-on tuition and mentorship, and the delivery of SAS training.