Medical devices
Janette Benaddi MICR
It is widely accepted in the device industry that in many cases, and with some particular devices, it is not necessary to conduct a clinical investigation in humans to be able to obtain the CE mark for a product. Janette explains the rigorous process of Clinical Evaluation, and when and how it can be applied instead of a Clinical Investigation.
Lorna Stewart MICR
As in the pharmaceutical industry, patient safety is the prime concern of medical device manufacturers and this applies throughout the product lifecycle, from development and clinical investigation to the post-marketing environment. Although many readers will be familiar with the requirements as they relate to pharmaceuticals, they are subtly different for medical device adverse events. Lorna explains…
Features
Joshua Schultz
Patient recruitment is a major challenge for every pharmaceutical company and CRO. To overcome this challenge, trial sponsors must be able to accurately predict trial recruitment rates, select sites with the greatest recruiting efficiency, and respond quickly to recruitment issues at each site once trial start-up is underway. Powerful new tools are available to help forecast recruitment trends and analyse site performance, but they must be implemented properly to achieve maximum benefits.
Chris Graf & Elizabeth Field
In the ten years since the original Good Publication Practice (GPP) guidelines were conceived, the development of a publication strategy for a new investigational product has changed from being a ‘nice idea’ to almost being an imperative for any pharmaceutical or biotech company. With all that has happened, it’s safe to say the time is right for GPP2: a new, revised version of Good Publication Practice. Chris and Betts explain the development process and how you can help.
Ashley Brooks, Paul Allen & Joseph Chiesa FICR
Up to half of all compounds entering clinical development fail because of unexpected pharmacological effects in humans. This often presents as poor tolerability, unwanted effects or poor pharmacokinetic (PK) profile. Microdose studies enable the human PK profile of new chemical entities and their metabolites to be characterised before conventional Phase 1 studies are carried out. This approach can accelerate and increase the efficiency of the drug development process.
Partner promotion
Andrew Catton
In an increasingly litigious and contractually onerous world, professional liability of independent consultants can create barriers to conducting business. Andrew Catton of presents a specialist insurance scheme for freelance CRAs and CTAs, exclusively for ICR members.
People
Roger Joby & David Bryde
Roger and David have both published and lectured on management of clinical research projects, including on ICR’s MSc in Clinical Research. They discuss the changing discipline of project management, why excellent CRAs sometimes become mediocre project managers and the myth of the fixed-price contract. A complete audio version of this interview is also available.
Prof. development
Michelle Noble
Some of you may have heard of and know a little about the ICR Special Interest Groups (SIGs) and Steering Groups but only a few of you will be fully aware of how much time, effort and work these people devote to the good of the entire ICR membership. Michelle explains…
Viewpoint
Andrew Smith
The current problems facing many businesses could be used as an opportunity for pharma to open their ‘war chests’ and snap up some acquisitions to bolster pipelines (and share prices) for far less than might otherwise have been the case. This is because big pharma companies are generally less ‘leveraged’ than many other industry sectors, particularly in comparison with their venture capital-funded colleagues in small biotech companies. But how much will actually change for us down ‘at the coalface’? Andrew ponders…
Regular updates
Gareth Hayes HonFICR
The variety of opportunities today is endless and everyone is making a pitch to continue the diversification. But this can be both a blessing and a curse when it comes to attracting new graduates into clinical research. With a myriad job titles springing up to describe specialist roles, and sometimes meaning different things in different organisations, Gareth asks whether we are gradually getting a handle on how to handle graduates…
