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Pharmaccovigilance Database Compliance

Pharmacovigilance Database Compliance Webinar

This free webinar examines the E2B(R3) regulations and how this impacts database compliance from both a practical and technical perspective.

Pharmacovigilance Literature Searches

Pharmacovigilance Literature Searches

This paper on 'Pharmacovigilance (PV) Literature Searches' explores optimizing search strategies for patient safety and presents the elements and requirements for a successful PV literature search strategy.

Validated SAS Macros in Clinical Trial Reporting

SAS Macros in Clinical Trial Reporting

Within this whitepaper, we will look at some of the potential pitfalls with the production of SAS Macros and what makes a successful process improvement project. We will discuss approaches and solutions that we identified to typical problems.

Semi Automated Patient Safety Narratives

Semi-Automated Patient Safety Narratives

This paper on 'Semi-Automated Patient Safety Narratives' explains what to do when a large volume of narratives is required within a restrictive time frame and details how a semi-automated approach to narrative writing can be used to address this challenge.

Remote Source Document Verification (rSDV) webinar

Remote Monitoring in Clinical Trials Webinar

In this webinar, you will learn how implementation, evolution and change management are critical for a successful remote monitoring program. But how does a remote monitoring program harmonize with current Source Data Verification practices?

Electronic Data Capture system selection

Electronic Data Capture (EDC) System Selection

In today’s clinical trial environment you are likely to consider selecting an Electronic Data Capture (EDC) system, with few companies opting for paper based solutions. Yet with the rapid pace of technological advancement, it can prove increasingly difficult to identify the right electronic solution(s) for your study/development program.

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Remote Source Document Verification (rSDV)

This ebook will explain rSDV's definition, present explored and piloted practices of conducting rSDV, the shortcomings of traditional monitoring and 100% SDV, and showcase the cost savings that can be incurred, as well as process efficiencies compared to traditional trial monitoring when using an rSDV approach.

pharmacovigilance webinar

The Challenges of Pharmacovigilance in Early Phase Clinical Trials Webinar

This free webinar looks at the challenges of pharmacovigilance in early phase clinical trials. We demonstrate the importance of PV in early phase clinical trials and how it is not just a check box exercise to satisfy regulatory bodies

 

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Patient Safety Narratives in Clinical Studies

This paper describes current regulatory requirements with regards to patient safety narratives. It details a proposed process for their development and review and examines ways to lessen the burden of time and cost.

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Sourcing Approaches within Clinical Development

This paper reviews the different approaches to sourcing in clinical development. Quanticate is seeing a wide range of sourcing scenarios and this paper assesses these different strategies. 

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Demonstrating Biosimilarity: Pharmacokinetic Considerations

In this white paper, we focus on some of the key issues which should be considered when performing pharmacokinetic analyses to prove clinical comparability between innovator biologics and recently developed biosimilars.

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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. This article explores balanced perspectives over narrow perspectives and how overall efficiencies and distinct efficiencies need to be separated.

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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 develops, the process of selecting a technology provider needs to examine a range of issues that didn't exist a few years ago.

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CDISC CDASH Guide

SDTM standards do 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.

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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. 

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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.

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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.

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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.

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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 consultancy team at 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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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.

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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.

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Important Considerations for Clinical Development Programmes

This 8-page article on Important Considerations for Clinical Development Programmes is for anyone embarking on the development of a new medicinal product.

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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).

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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.

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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.

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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.

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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.