All articles by trock
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Keeping tabs on trials
Selecting the right contract research organisation (CRO) is a critical decision for any pharmaceutical company looking to bring a drug to market successfully. But selection is just part of the equation. Lisa C Feeney and Lauri Sirabella of ExecuPharm explain why, even if you’re 100% certain your CRO is a good fit, overseeing and management of the relationship is critical to the success of the process.
The changing role of the data manager
The rise of CROs and the outsourcing of clinical trials are presenting clinical data managers with a variety of new challenges. Nic Paton talks to Adela Pau of Almirall about what these challenges entail and what can be done to address them.
Focus on your recruitment practices
Careful planning, a well-chosen site and a realistic protocol are key to the success of a clinical trial, writes Mercè de Frias, project manager at ADVANCELL.
Spread too thin?
Hedley Rees, managing director of pharmaceutical supply chain consultancy PharmaFlow, investigates if partnerships in clinical trials are the way forward or stretching the relationship too far.
Cool gadgets for the cold chain
The task of ensuring clinical supplies are fit for purpose begins right at source and ends at the point of use, and a key element is making sure they are not exposed to excess temperatures. Temperature monitoring technology has advanced significantly in recent years, and is now playing a major part in maintaining product integrity. Philip Chou of Elan Pharmaceuticals tells us how pharmaceutical companies and their suppliers can ensure temperature integrity through technology and procedures.
Kit-form clinical trials
Dr David Gilliland of Daiichi Sankyo presents a guide to packaging and converting patient kits for clinical trials as the size, scope and duration of these programmes increases.
Race to the top
Researchers from GlobalData, with reference to the ‘Biotech Strategy 2012 – Licensing, Collaboration and M&A Trends’ report, explain why they must consider various challenges that have come to the fore, including the impending patent cliff, declining innovation and the rapidly saturating pharmaceuticals market of the US and other developed countries in Europe.