Clinical Data Analysis: Avoiding Obstacles to Success

Webinar Preview

In the world of clinical data analysis, the starting point is deceptively easy: one person and a laptop with a few applications installed. But soon the team grows, your treatment moves toward approval, and your needs have quickly multiplied.

Without a centralized system, users can make multiple copies of data, which causes confusion about the source of truth. Small configuration changes can lead to differing results, causing more confusion. More importantly, access to data has to be properly managed; the wrong person having access at the wrong time can ruin clinical studies. Keeping systems fully validated and users on the same software release is another set of massive issues. These issues alone can place an enormous strain on internal information technology resources. And getting to the finish line can reveal another huge problem. Are you prepared in the event of an audit?

In this webinar, the expert speakers will also delve into the essential elements required to establish a robust statistical computing environment. Attendees will learn about the core needs of such an environment, including what must be monitored to maintain audit readiness. The discussion will also cover the components of a complete validation document set, providing a comprehensive guide on how to effectively prepare and organize these critical documents.

Speakers

Joe Olinger, Solution Owner, Instem

Joe Olinger has over a decade of experience designing, building and managing statistical computing environments for pharma companies and CROs. With extensive experience, he works as a Product Owner to deliver the highest quality experience for biostatistics teams.

Message Presenter

Phil Loucks, Account Manager, Instem

Phil Loucks has been creating a best-in-class experience for life science companies looking to upgrade their statistical computing environments (SCE) for almost a decade. His commitment to quality has ensured every client has found exactly what they are looking for in an SCE.

Message Presenter

Karena Kong, Director of Stat Programming, a Large Pharma

Karena brings over eighteen years of statistical programming experience from small biotechs to large pharmas. She has worked on all stages of clinical studies and in many therapeutic areas and has led programming teams through drug submissions and approvals.

Message Presenter