Clinical White Papers

These clinical white papers have been written by Quanticate managers and members of the Quanticate consultancy team. Feel free to click on the titles/images to receive the articles.

Making Metric Collection Obligatory in Clinical Trial Contracts
	An article on the importance of defining robust metrics at the outset of a study and of incorporating them into the contract. The article expands on the challenges of metrics development, the typical metrics collected in clinical trials, and on how best to manage the data collected.
Integrated Summaries of Safety and Efficacy: The Role of the Medical Writer
	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.
Phase 1 Studies: Roles and Obligations of the Medical Writer
	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.
PK/PD Models: Reducing Phase 3 Attrition Rates
	This short article outlines how thorough PK/PD modelling can significantly reduce the risk of failure in Phase 3 trials.
Overview of Challenges in Oncology Studies
	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.
Clinical SAS Programming Efficiently with Large SAS Datasets
	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.
Finding The Best Value Through Well Prepared Requests for Proposals (RFPs)
	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.
Making a CRO Project Run Smoothly
	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.