Quanticate CRO Blog

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 Outdated legislation and high profile scandals have made changes a necessity.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 2013.

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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

Efficient Data Reviews and Quality in Clinical Trials [Video]

Posted by Statistical Consultancy Team on Fri, Jun 13, 2014

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Tags: Bayesian Statistics, CDISC, FDA, Standardization, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), Randomization, SAS Programming, On-Site Monitoring, Serious Adverse Events (SAEs), Quality Control, Visualization, Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

Preparing for Big Data in Pharma

Posted by Nick Burch on Fri, May 23, 2014


 

Today, the Pharmaceutical industry, like many, has its feet in both camps when it comes to Big Data. Some parts of the industry, such as genomics and drug discovery, were early adopters and today couldn't imagine life without Big Data technologies and approaches. Others are pushing their current approaches to near their limits, and are beginning to consider "what's next?"

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Tags: Clinical Data Storage, Large Datasets, Big Data

Prentice-Wilcoxon Test for Paired Time-to-Event Data

Posted by Statistical Consultancy Team on Fri, May 16, 2014

In survival analyses we conventionally compare a time-to-event endpoint between two or more strata; patients are either represented in one strata or the other and the strata are independent of each other.
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Tags: Survival Analysis, Statistical Programming, Statisticians in the Pharmaceutical Industry (PSI), SAS Macros, Prentice Wilcoxon Test

7 Frequently asked Questions on Clinical Study Design

Posted by Statistical Consultancy Team on Fri, Jan 31, 2014

Quanticate has released several white papers around Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies. Our statistical consultancy team was pleased to receive feedback and questions from our clients and piers on these papers which we would like to share with you all below.

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Tags: Bayesian Statistics, Bayesian Study Design, Bayesian Methods, Phase I Studies, Clinical Study Design, Interim Analysis, Biostatistics Consulting, Phase I Study Design