2019-09-30
“A solid preclinical strategy will allow your project to take the shortest route towards clinical phase without compromising patient safety. Strategic planning while adhering to the demands in regulatory guidelines makes my job challenging and rewarding” Following guidelines is easy,…
2019-09-23
So what is so special about Phase I? “In my, opinion everything is! This is the first point when all disciplines are combined – product, pharmacology, toxicology and clinical with the objective to investigate if a new drug may be…
2019-09-16
“I work primarily with studies from the clinical phase of drug development where I provide advice and review protocols and CRF-designs, write Statistical Analysis Plans, prepare analysis databases and analyse and report clinical trials. My extensive experience in this field…
2019-09-10
“In my job I really appreciate helping life-science companies get the most out of the interactions with regulatory authorities, MPA, EMA or FDA. Here I can use my background to bridge between pharma and regulatory agencies” Why is a thorough…