How to Use Outsourcing to Reduce Clinical Development Risk

Posted by Esha Senchaudhuri

May 28, 2015 4:47:00 PM

Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development program at a time when regulatory standards are evolving, or competition is catching up with comparable products.

There is a particular source of risk, however, which deserves special attention. Currently, the pharmaceutical and biologics industry outsources approximately $25 billion dollars worth of clinical development projects. That is over a quarter of the $98 billion dollars currently devoted to clinical drug development.

This naturally raises several questions:

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Topics: Data Management, Clinical Research Services, outsourcing, Clinical Development Strategy


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


How to Incorporate New Technology into Your Clinical Development Strategy

Posted by Cytel

Dec 2, 2014 11:00:00 AM

During a recent DIA webinar on reinventing the clinical trial, Laurie Halloran (President of the Halloran Consulting Group) and Irving Dark (Senior Vice President at Cytel) weighed in on a wide array of recent technological breakthroughs that life sciences companies can leverage to simplify clinical development. Their discussion ranged from simple techniques to cut down the 80,000 sheets of paper used for the average clinical trial (“Take it to the Cloud!”) to remote centralized monitoring techniques that make use of cutting edge statistical innovations.

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Topics: Data Management, Clinical Research Services, Entrepreneurship


7 Reasons to Add a Statistical Consultant to Your Team

Posted by Cytel Consulting

Oct 14, 2014 11:05:00 AM

We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions? 

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel for the industry enables statistical consultants to generate novel solutions to an array of challenges faced while navigating clinical development.

If you are thinking of hiring a statistical consultant to your team, you should be aware of the many roles that they can play. Here are some of our consultants' favorite recent projects. 

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Topics: Data Management, Cytel Strategic Consulting, Cytel Consulting


Data Management and Biostatistics III: Statistical Innovation in Clinical Data Management

Posted by Esha Senchaudhuri

Jul 24, 2014 1:30:00 PM

This is the third post in a three part series in which we 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.)

For previous posts click here: 

“They’d report somebody dead, and two months later they’d report that the person was taking therapy.” [1]

This was clinical data in the early 1960s, according to Marvin Zelen, Research Professor in Biostatistics at the Harvard School of Public Health. More precisely, this was emblematic of the type of frustration that led Zelen and others at the Eastern Cooperative Oncology Group to develop the role, function and methodology of ‘data management’ in efforts to improve data quality for confirmatory clinical trials. 

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Topics: Data Management, Clinical Research Services, Marvin Zelen


Data Management & Biostatistics II: Operational Benefits of Bundling

Posted by Esha Senchaudhuri

Jun 3, 2014 7:30:00 AM

This is the second post in a three part series in which we 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, Clinical Research Services


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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