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The Role of a Statistician In a Pre-Clinical Study

Statistical Consultancy Team

Pre-clinical trials, involving experiments in-vitro (literally ‘in glass’, i.e. in the laboratory, typically involving cells) and in-vivo (‘in animals’) are an essential part of drug development as it is a regulatory requirement  to investigate the safety of new drugs in-vitro and/or in-vivo before they are tested in humans. These trials can also be used to investigate the potential efficacy of new compounds.

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Topics: Pharmacokinetics and Pharmacodynamic, Randomization, Specialist Biometrics CRO, Pre-Clinical Study, Biostatistics Consulting

Challenges and Rewards of Working in a Clinical Research Organization

Medical Writing Team

The business of Clinical Research Organizations (CROs) has been expanding recently due to the slow growth in the pharmaceutical industry. Working for a CRO offers numerous challenges and rewards. The following highlights some of these in greater detail:

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Topics: CRO Selection, Specialist Biometrics CRO, CRO Project, Clinical Research Organization, Request For Proposals

Making a Clinical Research Organization Project Run Smoothly

Commercial Team

When embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a project runs smoothly from the start. Following a formalised handover from business development to operations, a face-to-face kick off meeting is important.

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Topics: CRO Selection, Specialist Biometrics CRO, Outsourcing Solutions, Strategic Resourcing, CRO Project

The Use of Propensity Scoring in Pooling Data across Clinical Trials

Statistical Consultancy Team

A member of Quanticate's statistical consultancy team presented a poster on “Using a Propensity-Pairing Algorithm to Reduce Bias due to Imbalances in Covariates: A Case Study Pooling Data from 5 Kidney Transplant Trials” at a conference for statisticians in the pharmaceutical industry (PSI).  This work uses a range of statistical methods including stepwise logistic regression, conditional logistic regression, principal component scores and mixed modeling.

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Topics: Randomization, Specialist Biometrics CRO, Biostatistics Consulting, Propensity Scoring

Why Consider Functional Outsourcing by a Functional Service Provider?

Yvonne Moores

One of the key components of a Strategic Resourcing model is the provision of staff through functional outsourcing. This approach has enabled global CROs to deliver genuine value and great customer care to many of the leading pharmaceutical companies around the world as they operate as functional service providers. Underpinning all of a CRO’s FSP (functional service provision) agreements is the commitment to the development of a strong, long-term relationship between the CRO and customer where resources are aligned with the customer’s needs to ensure quality project delivery.

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Topics: Specialist Biometrics CRO, Outsourcing Solutions, Strategic Resourcing, Functional Outsourcing, FSP

Biomarkers in Drug Development

Statistical Consultancy Team

The identification of novel and effective biomarkers in drug development is considered a key feature in the optimization of the drug development process. But what exactly is a biomarker? As defined by Grutolla et al. [1], a biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Examples include concentrations of particular proteins in the blood or bone marrow, liver function tests or PET imaging as indicators of disease state or therapeutic benefit.

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Topics: Bayesian Study Design, Phase I Studies, Biomarkers, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design, Drug Development

Adaptive Design and Bayesian Methods – Controlling Time and Cost

Statistical Consultancy Team

When planning a clinical study there are considerable financial benefits to seeking out the latest available scientific knowledge and most appropriate statistical approaches to study design. Over the years many adaptive design and Bayesian methodologies have become widely used, but choosing the right ones at the right time is crucial to placing control over research programmes at all stages of development. Well planned study designs ensure the best project go/no go decisions and lead to the earliest possible technical and regulatory success.

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Topics: Bayesian Statistics, Bayesian Study Design, Specialist Biometrics CRO, Biostatistics Consulting, Adaptive Trial Design

Bayesian Study Design & Interim Analysis In Clinical Trials

Statistical Consultancy Team

Interim analyses are widely used in clinical trials. They offer companies the opportunity to stop studies early in cases where it looks as if the primary objective will not be achieved (often referred to as ‘stopping for futility’).

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Topics: Bayesian Statistics, Bayesian Study Design, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Adaptive Trial Design

An Introduction To Biostatistics In Clinical Trials

Statistical Consultancy Team

 

A biostatistician is not just a number-crunching individual providing a p-value, making sense of data and identifying whether treatment A worked better than treatment B. Biostatisticians in clinical research are typically integral members of project teams providing advice throughout the entire compound development process, offering far more than a service just to be dipped in and out of whenever numbers crop up.

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Topics: Bayesian Statistics, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Adaptive Trial Design

Economical Designs for Phase I Studies

Statistical Consultancy Team
The objectives of the Phase I development plan are many. Alongside establishing the safety, tolerability and pharmacokinetics (PK) of single and multiple doses in humans and ascertaining the maximum tolerated dose, it is often important to explore at least some of the following:
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Topics: Statistical Programming, Pharmacokinetics and Pharmacodynamic, Phase I Studies, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design

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