Full service or specialized? Full service or specialized?

For many looking to hire a CRO, the answer is obvious.

Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received priority review status. Following submission, regulators requested that our client also submit pooled data from its Phase 1 studies along with a safety analysis. This analysis had the potential to clinch NDA approval for the new product.

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...

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...

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...

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...

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...

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...

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...