Late phase
Strategic & Operational Considerations in Late Phase Research
Jean Siebenaler MD
It is not surprising that biopharmaceutical companies undertake a diverse array of study types under the late phase umbrella. As the cost of clinical development research continues to spiral, it is imperative that they maximise the return on their product investment through lifecycle management activities. Jean Siebenaler explores the strategic, methodological, practical and regulatory considerations when conducting research from phase 3b onwards.
From A to B… to Q… to Z: Facing Growing Study Complexity & Global Opportunities in Managing Materials Behind Clinical Studies
Alain Eudaric
In today’s increasingly complex, global clinical development environment, clinical logistics is expected to take on a more important role. More complex studies make more exacting and differing demands of logistics, while the growing importance of emerging countries makes meeting these demands more challenging, and brings additional demands of its own. Alain Eudaric explores how organisations can meet these important challenges.
Features
Ethical Personnel Recruitment in the Current Marketplace: ICR Resourcing Forum
Andrew Smith
When you need to recruit staff to run your study but have a shortage of candidates, is it okay to let your business ethics slip? Are techniques like cold-calling justifiable solutions to a short-term need, or do they simply damage your reputation? How does a recruiter walk the line between being competitive and being unprofessional… even if their job depends on success? These were the issues explored at the ICR Resourcing Forum in May, and Andrew Smith was there…
Rapid Access to Specialist Skills: The Hows & Whys of Interim Management
Tim Ewbank
Outsourcing in the pharmaceutical and biotech industries has grown markedly over the years. The bulk of this relates to CROs taking on entire clinical trials or complete programmes. However, if it is preferable to keep the work in- house, the expertise of individual specialists at different stages of the project can be helpful. Tim Ewbank explains how interim managers can help.
People
Managing CRO Operations Across Europe, Middle East & Africa: An Interview
Roger Newbery
Roger Newbery is Vice President of Clinical Management for Europe, Middle East and Africa (EMEA) at PPD. In this interview, he discusses the issues of running clinical trials in developed and developing countries, the impact of the EU Directive and his passionate belief in the value of developing new medicines. A complete audio version of this interview can also be downloaded.
Professional development
More Similarities, Subtle Differences: Globalisation of the CRA
Laura Parkes RICR & the ICR CRA SIG
The role of the CRA could certainly be seen as a varied one. Whilst the basis of the job is the same for CRAs the world over, there are subtle differences in the role of a CRA working in the UK versus other EU member states or countries in other regions. Laura and the ICR CRA Special Interest Group explore these similarities and differences.
Viewpoint
“Seeding Studies” & Scientific Value
Andrew Smith
In August, a paper was published alleging that the ADVANTAGE study on Vioxx was a “seeding study” (an allegation strongly denied by those who worked on the study).Andrew argues that the scientific value and rigour of any study outweighs any additional motivations, from ‘seeding’ to ‘vanity’.
Regular update
Do Think & Drive!: Message from the Vice Chair
Gareth Hayes HonFICR
In out 24/7 working life, we are all driven… both literally and metaphorically. Gareth explores this analogy, suggesting that we plan more, drive more slowly to avoid congestion and accidents, and resist the temptation to use technology as a replacement for thinking rather than a tool to help us think.
It's Not All Work, Work, Work...
In our new series looking at the lighter side of clinical research, we ask you where you read your copy of CRfocus, and suggest ‘Ten Things You Wouldn’t Want to See in an SOP File’!
