Quanticate CRO Blog

The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]

Posted by Clinical Programming Team on Thu, Mar 26, 2015

In this recorded presentation a member of the Quanticate's Clinical Programming Team explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis.

 

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Tags: Pharmacokinetics and Pharmacodynamic, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, Clinical Programming, SDTM, CDISC Standards, PK Analysis, ADaM Datasets

Total Value Ownership of selecting a partner for Clinical Development

Posted by Daniel Chapple on Mon, Mar 16, 2015

Total Value Ownership (TVO) is not a new concept but it is an area that has attracted much interest in recent years. It can help in determining the best approaches to take and suppliers to use, by demonstrating the real value of selecting a certain partner in clinical development.

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Tags: CRO Selection, Outsourcing Solutions, CRO Project, CRO Efficiency, Clinical Research Organization, Clinical Data Services, Functional Outsourcing, Total Value Ownership

Ben Goldacre Discusses Clinical Data Transparency [Video]

Posted by Statistical Consultancy Team on Mon, Feb 23, 2015

Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency. 

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Tags: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Electronic Medical Record (EMR), Adverse Events (AEs), Historical Data, European Medicines Agency, Clinical Trial Documentation, Clinical Documents, Ethics, Accessible Data, Data Transparency

An Overview of Efficacy Endpoints in Oncology Studies

Posted by Clinical Programming Team on Fri, Jan 09, 2015

This blog provides an overview of efficacy endpoints in oncology studies. We will focus on RECIST (Response Evaluation Criteria In Solid Tumours).This is a method of assessing how solid tumours change over the course of a study. We will cover the measurements taken for RECIST assessments (Target lesions, Non target lesions, New lesions) and the possible outcomes, (complete response, partial response, stable disease, progressive disease) and what they mean – for example; patient recovered, stayed the same or got worse. We will also cover how visit windows and censoring can be handled. How and why measurement methods are important.  We will cover other endpoints relevant to oncology such as Overall survival, Objective Response Rate, Best overall response, Disease control at X weeks and quality of life.

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Tags: Clinical Programming, Ethics, Oncology

How will the change in European Device Regulations affect vigilance practices?

Posted by Pharmacovigilance Team on Thu, Dec 11, 2014

On 22 October 2013 the European Parliament agreed to new proposals for regulation on Medical Devices and in vitro diagnostic medical devices. Outdated legislation and high profile scandals have made changes a necessity. This is despite disagreements between legislators and industry over the content of the new legislation. But how will this impact vigilance practices and will it stop medical device scandals from ever happening again?

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Utilizing a Bayesian Informative Prior to Reduce Sample Size in Clinical Trials

Posted by Statistical Consultancy Team on Thu, Nov 13, 2014

Bayesian statistics in clinical trials are becoming more widely used in the pharmaceutical industry. By gathering data from historical studies, it is possible to reduce the sample size of the current trial by using an informative prior in the Bayesian analysis. This blog explores five cases in different indications that have historical data on placebo subjects from the literature, and calculates the effective sample size using an informative prior. In some cases, the effective sample size is substantial, but in others there are no sample size savings despite abundant data in the literature.

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Tags: Bayesian Statistics, Bayesian Methods, Statistical Programming, Biostatistics Consulting

How Big is Big Data in Clinical Trials – Tall, Grande, Venti Data?

Posted by Nick Burch on Fri, Aug 29, 2014

 

Today, Big Data is one of the hot topics within almost every Industry, especially in clinical trials. May saw the biggest ever European technologists conference on this, Berlin Buzzwords, while the likes of O'Reilly's Strata conference pull in huge numbers of attendees keen to learn how to adapt to this new world.

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Tags: Clinical Trials, Clinical Data Storage, Clinical Study Design, Medical Device, Big Data

Hitting New Targets - EPC Interview with David Underwood

Posted by David Underwood on Mon, Aug 18, 2014

European Pharmaceutical Contractor held an interview with Quanticate CEO; David Underwood, asking how he started in the pharmaceutical industry, the reasons behind Quanticate's recent success and future trends as well as regulations in the industry.

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Tags: Clinical Trials, Bayesian Methods, CEO's Insight, Visualization, Adaptive Trial Design

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Posted by Statistical Consultancy Team on Fri, Jul 18, 2014

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Tags: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

Is Multiple Imputation in Clinical Trials Worth the Effort?

Posted by Statistical Consultancy Team on Mon, Jun 30, 2014

In a case study examined to look at Multiple Imputation (MI) in clinical trials, comparing Active to Placebo treatment (at Weeks 2, 4, 6 and 12 of the trial) in adolescents with acne, drop outs were common.  The primary endpoint was the number of lesions at Week 12.  The factors believed to affect the propensity to be missing included age, side effects and lack of efficacy, and thus missing data patterns differ between groups. 

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Tags: Statistical Programming, FDA, SAS Programming, Statisticians in the Pharmaceutical Industry (PSI), Propensity Scoring, Multiple Imputation