Meet a 100% R-based CRO - the summary of a 5-year journey

Abstract

Nowadays R is the talk of everyone in the pharmaceutical industry. A lot is being said about statistical programming (CDISC datasets, TFLs) with R and addressing validation issues. The most important players embraced R in various areas of their activity and share their experience, develop game-changing tools, and propose solutions. But the market consists also of small CROs, like ours, fully based on R, harnessing it in all areas of our statistical and programming work from the trial design, through creation of datasets, conducting planned and ad-hoc statistical analyses, generation of the TFLs, ending with the validation of both the outcomes and the R software itself. In the last 5 years of daily work with R, we gained a solid hands-on experience. Now we would like to share our story the problems we faced, the measures we tried and the solutions that have proven successful. We believe in the importance of sharing experience from diverse subjects, as small CROs have their own specificity, needs and possibilities in terms of budget and people. This raises the awareness of differentiated challenges and needs, so important in working out effective, broad-based ways to make R a worthy competitor of the current industry standards.

Type
Publication
Presented at 2022 Conference

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