How Your Long-Term Data Strategy Can Increase The Value Of Your Clinical Asset

Setting up and running a clinical trial is an exciting, time-consuming and expensive activity. Success is driven by attention to detail and the thoughtful application of energy to the study. Typically, it is the clinical aspects of the study where most time is consumed and money spent, thus it attracts most of the attention.

But wait, step back and think, why is the study being conducted? Answer: to collect data from the clinic, analyze it and assemble it with data from other studies into a package for regulatory or licensing purposes. After all the dust has settled, the database is locked, documents archived and all is brought to a close, it is the data that truly matters, and more importantly, what happens to that data as the clinical development of a compound reaches each milestone.

The moment you decide that a clinical program needs to be conducted (typically two or more studies), stand back and think about the end of the program. As the old cliché goes, “Start with the end in mind.” How are you going to collect and assemble the consolidated clinical trial data so that it meets or exceeds the expectations of your eventual customer - a regulator, prospective licensing partner or investor?

This article looks at the answer to this question by comparing outsourcing models and making some practical suggestions regarding CRO partner utilization and strategy.