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Volume 16 Issue 1
 
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Risk-based Monitoring: The New Regulatory Landscape, and Conjectures on the Future of Clinical Trial Execution

In early August 2011 the European Medicines Agency released a draft document entitled Reflection Paper on Risk Based Quality Management in Clinical Trials. Later the ...
25 September 2012 Uncategorized
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Developing Stem Cell Therapy for ALS: The Challenge

ALS is a devastating disease affecting a wide range of individuals, from young adults to senior citizens. The progressive and highly debilitating nature of the diseas...
25 September 2012 Uncategorized
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Proactive Planning for Subject Recruitment and Retention are Critical to Modern Clinical Trial Success
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Proactive Planning for Subject Recruitment and Retention are Critical to Modern Clinical Trial Success

Despite countless industry efforts to improve efficiency in the planning and execution of clinical trials, 80 per cent of studies are delayed in their completion by a...
25 September 2012 Uncategorized
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Maximising the Role of Statisticians and Programmers to Reduce Timelines in Integrated Summaries of Safety and Effectiveness

An ISS is an Integrated Summary of Safety, and an ISE is an Integrated Summary of Effectiveness. An ISS combines the safety results from different studies conducted i...
25 September 2012 Uncategorized
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Paediatric Regulations are Permanent: Approaches for Overcoming the Challenges of Paediatric Drug Development

Global regulators have, for many years, put in place provisions and regulations to ensure that children’s specific medical needs are addressed through structured clin...
25 September 2012 Uncategorized
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Good Distribution Practices – Why and to What Detail GDP-contracts between Sponsors/Manufacturers and Distributors are Needed

A revision of the European GDP-guideline has been published for public consultation on December 31, 2011. Although defining the requirements for the wholesale distrib...
25 September 2012 Uncategorized
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FDA Expands Rules on the Disqualification of Clinical Investigators

In April 2012, the US Food and Drug Administration announced in the Federal Register the publication of a final rule to amend the investigational new drug application...
25 September 2012 Uncategorized
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Global Commercial Drug Supply for Trials: How to Achieve Long-term Success
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Global Commercial Drug Supply for Trials: How to Achieve Long-term Success

In the past, the majority of companies were rather naive regarding their options for sourcing comparator medications. Some companies, even large ones, were relying on...
31 July 2012 Uncategorized
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London 2012: Potential Logistical Challenges

Unless you have been living under a rock for the last four years, you can’t have failed to have noticed that the 2012 Olympics are taking place in London this summer!...
13 June 2012 Uncategorized
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