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This paper looks at how a Medical Writer should contribute to the production of a quality ISS/ISE. It follows a previous white paper on the role of Statisticians and Programmers in the production of integrated summaries. |
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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 article outlines the support needed from medical writers during the design, conduct and reporting of Phase I studies, but also their obligations when it comes to publishing results. |
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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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This short article outlines how thorough PK/PD modelling can significantly reduce the risk of failure in Phase 3 trials. |
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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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If you are planning an oncology study you will be aware that these studies are more complex than others. Our consultant team in Quanticate have put together an initial article that outlines the typical challenges presented by such studies and offers some recommendations to counter them. |
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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 14 page article looks at SAS® programming techniques to help you program more efficiently. Size reduction techniques for large datasets are explored to give you smaller sized, faster running, more efficient programs. |
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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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A 3 page article on getting Request For Proposals right so that the months which follow will be much more enjoyable. The article expands on the concept of a verly clearly defined RFP being the starting point for a clinical study to run smoothly and stay within budget. |
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A 2 page article on the initial steps for smooth practices when embarking on new outsourcing projects. This paper touches on teething problems and helping to find the right team. |
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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. |