The Guidance for industry published by the Food and Drug Administration (FDA) was devised to make the process of developing and reviewing Patient Reported Outcome (PRO) measures more efficient and transparent. Tim Davis of Exco InTouch explains the guidance.
Adam Jacobs, Director of Dianthus Medical Limited looks into headlines such as “Evil Big Pharma kills patients in bid for global domination”, and concludes that it is of the utmost importance to be aware of the potential for bias and to guard against it with systematic review the default position whenever a review paper is felt to be useful.
Dr. Patricia Lobo, Editor of IPI & Managing Director of Life Sciences Business Solutions, speaks with Dr. James Sawyer MFPM, CEO of Prism Ideas
Drug development consultancy and medical communications both require clinical and scientific excellence, and the services are inherently linked. The data generated during drug development drives our understanding not only of the drug itself, but also the biology of disease.
Gareth Maguire of Almac Group explores models of overcoming hurdles such as long timelines, towering costs and soaring rates of attrition, in a world where the future growth of our economies is largely dependent on innovation from the pharmaceutical sector.
Scott Berry of Berry Consultants & Tom Parke of Tessella discusses the considerable scope to exploit new trial designs in the development of cancer treatments.
Companies can control messaging and information delivery from their medical affairs platforms by using an integrated event management solution through which unpredictable enquiries from healthcare professionals and consumers into your organisation can be managed. Charles T. Saldarini, CEO of Sentrx gives you a few special tips to help you savour the improvement process.
The practice has become entrenched in many areas of industry including the pharmaceutical and biotech industries, and has fuelled a boom in companies carrying the acronym CRO (Contract Research Organisation). Scott Clark, of Quanticate evaluates all of these areas to make an informed decision on whether to internally develop or outsource your needs.
New devices for dispensing ophthalmic treatments may be the key to managing the life-cycle of established products with low investments in filling technology
Matthias Birkhoff & Dr. Degenhard Marx of Aptar Pharma describes the targeted approach for the development of new preservative-free multidose devices for ophthalmic medications.
Basic Biostats for Clinical Research – Confidence Intervals in Drug Development – An Overview of their Use and Interpretation
This paper by Dr. Rick Turner of Quintiles & Dr. Russell Reeve of Quintiles is the first in a new series called Basic Biostats for Clinical Research.