Clinical White Papers and Thought Leadership

These clinical white papers and thought leadership articles 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.

A balanced approach to program efficiency and data efficiency within Clinical Programming
	This white paper looks at how the different perspectives to achieving efficiency in Clinical Programming can be achieved. The article explores balanced perspectives over narrow perspectives and how overall efficiencies and distinct efficiencies need to be separated.
Then and Now: Is Clinical Trial Technology Selection and Implementation Becoming Easier?
	As the choices for different clinical trial technologies grow, and the existing relationship between a sponsor and a CRO developes, the process of selecting a technology provider needs to examine a range of issues that didn’t exist a few years ago.
CDISC CDASH – A Guide to Linking Clinical Data Management to Clinical Programming and vice-versa
	SDTM standards to not always lead themselves well to data capture, this guide looks at using CDASH standards to provide a common ground to facilitate the capture of data when linking processes across clinical data management and clinical programming.
Translational Pharmacology: The Key to Ensuring Safe and Effective Dosing
	PKPD models are becoming increasingly critical knowledge-building tools, not only for late phase clinical trials, but throughout the entire drug development process. Biologics Consulting Group and Quanticate are pleased to announce the publication of a white paper on this important topic titles – “Translational Pharmacology: The Key to Ensuring Safe and Effective Dosing”.
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.
Traceability – Where is your Clinical Information?
	This paper outlines why sponsors of clinical trials should re-examine and plan for proper traceability of their clinical information.
Important Considerations for Clinical Development Programmes
	This 8 page article on Important Considerations in Clinical Development Programmes is for anyone embarking on the development of a new medicinal product.
Integrated Summaries (ISS / ISE)
	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).
Flexible Phase I Study Designs: Expediting Early Clinical Drug Development
	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.
Bayesian Study Design: Using Interim Analyses to Improve Efficiency in Drug Development
	This second article expands on how the Bayesian framework is highly appropriate for planning and executing interim analyses in your clinical trial study design.
Bayesian Study Design: The Pragmatic Solution for Phase II Clinical Development
	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.
Clinical Conclusions: Producing Comprehensive Integrated Summaries
	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.
Current Trends in Pharmacovigilance
	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.
Costs of Outsourcing vs Internal Deployment
	This 6 page article identifies cost factors that companies need to assess to make an informed decision on clinical outsourcing or the use of internal deployment.
Benefits of Centralizing Clinical Data Services
	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.
eProposals: An Interactive Approach to eProcurement
	This 7 page article discusses the benefits to all parties involved in the vendor selection process when considering eProposals.