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:

Read More

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


Adaptive SSR for Small Sample Sizes?

Posted by Esha Senchaudhuri

Apr 21, 2015 6:09:28 PM

“We shouldn’t use an adaptive design, our sample size is too small.”

Most clinical trial planners have heard this line of reasoning so often it has come to be taken as true. Never mind the fact that the first product to receive FDA approval using an adaptive sample size re-estimation design, was for a genetic condition affecting fewer than two thousand children worldwide [1].

Read More

Topics: Clinical Research Services, Rare Disease, Clinical Development Strategy, Adaptive Clinical Trials


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.

Read More

Topics: Data Management, Clinical Research Services, Entrepreneurship


You Own This!

Posted by Laurie Halloran (Guest Blogger)

Oct 7, 2014 2:00:00 PM

Guest blogger Laurie Halloran is the President and CEO of Halloran Consulting Group, a management consulting firm for the life-sciences industry. Here she offers her take on the importance of accountability, obligation and 'ownership' in consulting for pharmaceuticals and medical device companies.

Read More

Topics: Clinical Research Services, Cytel Consulting, outsourcing


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. 

Read More

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.)


 

Read More

Topics: Data Management, Clinical Research Services


Cytel's CliPLab: Training the Next Generation of Clinical Programmers

Posted by Esha Senchaudhuri

May 27, 2014 7:09:00 AM

Although collaboration between industry and academia has been a longstanding tradition in the field of drug development, existing industry forces are reshaping the nature of this partnership. According to Cytel India's Chief Executive Ajay Sathe, the projected expansion of the drug development market between now and 2017, comes at a time when both industry and academia are challenged to supply new and innovative young talent. While some universities offer comprehensive programs in computation, programming, biostatistics and bioinformatics, such an all-encompassing curriculum is rare. Even when possible, the combined contributions of these disciplines to the day-to-day challenges of statistical analysis and data management are often difficult to comprehend without industry experience.

Read More

Topics: Clinical Research Services, Cytel CliPLab, Statistical Programming, Training and Education


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.)

Read More

Topics: Data Management, Trial Quality, Clinical Research Services


The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.  Sign up for updates direct to your inbox. You can unsubscribe at any time.

 

Posts by Topic

see all

Recent Posts