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.

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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. 

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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


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.

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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.)

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Topics: Data Management, Trial Quality, Clinical Research Services


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