How to ensure independence of QC in statistical programming 

Posted by Cytel

Nov 11, 2016 10:05:14 AM

A solid and robust QC process is one vital component of ensuring quality programming delivery. Angelo Tinazzi and Cedric Marchand presented at the PhUSE conference recently on the topic of ‘What Auditors want’. As part of this well received presentation, the duo discussed the question of independence of QC and how to make sure this is fully observed.

In this blog we’ll walk through their recommendations to ensure independence of QC in programming.

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Topics: Trial Quality, Statistical Programming, Statistical Analysis, CDM

Regulation and Reproducibility: Can You Reproduce Your Clinical Trial Results?

Posted by Esha Senchaudhuri

May 15, 2015 1:33:15 PM

Cytel Clinical Research Services

Imagine that it’s been three years since the completion of a trial, and that suddenly a regulatory body calls into question the findings:

  • Was a particular trial site operating properly?
  • Can you clarify an aspect of the results? 
  • Why did you make a particular decision at an interim look?

Suddenly, your somewhat old data needs to be able to reproduce your initial findings. In such a case, how long would it take you to satisfy the regulatory body?

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Topics: Data Management, Trial Quality, Trial Monitoring, FDA, ACES

Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios

Posted by Esha Senchaudhuri

Sep 2, 2014 11:19:00 AM

As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs can result in significant improvements to a trial’s financial risk profile. Regardless of a trial’s eventual success or failure, a well-constructed design provides a drug with the highest possible probability of success while mitigating financial risk.

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Topics: Nitin Patel, Cyrus Mehta, Promising Zone, Trial Quality, Cytel Strategic Consulting, Trial Design, Entrepreneurship, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials

Statisticians on Software Development Part I: Statisticians from Cytel, SAS and Stata talk Software Development

Posted by Esha Senchaudhuri

Aug 26, 2014 3:00:00 PM

During an invited speakers session at the lnternational Society for Clinical Biostatistics, Cytel VP Yannis Jemiai was joined by R.N. Rodriguez from the SAS Institute and IR White (formerly of Stata), to discuss innovations in software for clinical trials.

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Topics: East 6.3, Trial Quality, Trial Design, Entrepreneurship

What Horsepower Can Teach us about Well-Powered Trials

Posted by Esha Senchaudhuri

Aug 12, 2014 8:30:00 AM

Beyond Wild Horses: Developing Innovation at Cytel

"Horse-and-pony" by arjecahn on flickr. -
Automotive affluential, Henry Ford, once said: "If I'd asked customers what they wanted, they would have told me a faster horse!" 
Thanks to a keen understanding of customers' needs and not merely a statement of their wants, Henry Ford was able to revolutionize the automotive industry with the first 26-horsepower engine for the Cadillac Automobile Company (then known as the Henry Ford Company). Not long afterwards, Ford designed the engine for the Ford Model 999 racer, with a reported horsepower of over 86. He went on to develop the Ford Model T and Model A, and the Ford Trimotor aircraft. 
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Topics: East 6.3, Trial Quality, Trial Design, Entrepreneurship

'Multivariate Approaches for Risk-Based Monitoring' An Adaptive Design (Slides Attached)

Posted by Esha Senchaudhuri

Jul 1, 2014 9:47:00 AM

A recent Cytel Seminar on Adaptive Statistical Designs featured a talk by Michael Elashoff (Patient Profiles) on Multivariate Approaches for Risk-Based Monitoring. Elashoff, a former statistical reviewer at the Food and Drug Administration, recommended combining cluster and rules based methods for statistical monitoring. Such adaptive monitoring approaches can substantially reduce the time and expense of data monitoring while ensuring consistently high data quality. 

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Topics: Access to Slides PDF, Trial Quality, Trial Monitoring, Adaptive Clinical Trials

Data Management & Biostatistics I: Improving Trial Quality

Posted by Esha Senchaudhuri

May 22, 2014 4:28:05 PM

This is the first of a three part post in which we will consider (i) improvements to trial quality that result from bundling data management with biostatistics, (ii) reductions in cost and study length that result from bundling data management with biostatistics, and (iii) the contributions of statistical innovation to clinical data management, such as those by Cytel Board member Professor Marvin Zelen (Research Professor and former Chair of Biostatistics at the Harvard School of Public Health.)

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Topics: Data Management, Trial Quality, Clinical Research Services

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