Here we share with you two articles we think you will enjoy:
White paper: Correction of ePRO data (by Elise Langenkamp)
ePRO solutions allow patients to report clinical trial information directly from mobile devices into electronic CRFs. Obviously, ePRO has a lot of advantages over paper and pen. Regulatory authorities however, have given critical findings related to handling of ePRO data in the past. This white paper describes the considerations regarding data changes in ePRO clearly and completely, providing options for sponsors.
Read the full paper here
A day in the life of a Statistician (by Phastar)
As statisticians, we love a bit of variation! A day in the life of a statistician at PHASTAR is no exception – depending on the stage of assigned projects and the nature of the studies we’re involved with, we could be providing input to the design of a study, calculating sample sizes, writing statistical analysis plans (SAPs), writing ADaM specifications, programming datasets, TLFs or efficacy analyses, or, providing expert statistical advice to our clients.
Read the full article here
The growing challenge of handling multistream data capture in clinical trials – ACDM 2019
By José Matamoros Luna MSc, Clinical Data ManagerThis year’s annual conference of the Association for Clinical Data Management (ACDM) took place in Amsterdam. During a two-day event, the emphasis was on the growing challenges of multistream data capture in clinical trials, with additional focus on risk based monitoring (RBM) and regulatory inspection findings.
Read the article here
GSK and Pfizer merge healthcare businesses to make new £10bn consumer drugs giant (published in the Independent)
The move will allow Glaxo to split in two – one part selling over-the-counter medicines, the other researching new pharmaceuticals and vaccines.
Read the article here
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