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This paper outlines why sponsors of clinical trials should re-examine and plan for proper traceability of their clinical information. |
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This 8 page article on Important Considerations in Clinical Development Programmes is for anyone embarking on the development of a new medicinal product. |
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In this 9 page article Quanticate outlines the issues that can arise in the planning of an Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE). |
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This article outlines the considerations that need to be made at the planning stage, and how to make best use of emerging PK and safety data to enable informed decisions regarding study progression. |
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This second article expands on how the Bayesian framework is highly appropriate for planning and executing interim analyses in your clinical trial study design. |
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If you are planning a Phase II study, you may find this 8 page article useful as it looks at how the Bayesian framework provides solutions for clinical development teams. |
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This 3 page article looks at some of the areas where regulatory guidelines are lacking on the preparation of integrated summaries. It identifies some of the pitfalls (and solutions) for the unwary who need to manage the quality and cost of producing integrated summaries. |
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A 4 page article talks about a need to improve pharmacovigilance systems to more effectively monitor and take action on safety issues associated with medicines. |
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This 6 page article identifies cost factors that companies need to assess to make an informed decision on clinical outsourcing or the use internal deployment. |
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This article looks at the advantages of centralizing those “back end” services whether it is internally by the Sponsor, with a full service CRO or with a specialist biometrics CRO. |
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This 7 page article discusses the benefits to all parties involved in the vendor selection process when considering eProposals. |