Clinical Data Analysis:
Avoiding Obstacles to Success

Date
Wednesday, September 11, 2024Wed, Sep 11, 2024
Duration
60 min
Ready On-Demand
Free — start watching in secondsFree

About this webinar

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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?

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This webinar offers insights on ensuring data and results are kept safe and secure, addressing best practices for data protection and security measures in statistical computing. This information will equip attendees with the knowledge to enhance the integrity and reliability of their statistical analyses and maintain compliance with regulatory standards.

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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.

Who should attend

This webinar will appeal to Managers, Directors and VPs with the following job titles or those working in the following fields:
  • Biostatistics/Biometrics/Clinical Data
  • IT Services/IT/IT Compliance
  • Statistical Programming
  • Clinical Compliance/Clinical Data Services/Clinical Data Management
  • Clinical Data Operations

What you will learn

Attendees will learn about:
  • The core needs of a statistical computing environment
  • What needs to be monitored for audit preparedness
  • The components of a complete validation document set
  • How to ensure your data and results are safe and secure

Featured Speakers

Joe Olinger, Solution Owner, Instem

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.

Phil Loucks, Account Manager, Instem

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.

Karena Kong, Director of Stat Programming, a Large Pharma

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.

Partner for this event

Instem

A global provider of leading software solutions and scientific services, Instem is helping clients bring their life enhancing products to market faster.

We enable organizations in the life sciences to more efficiently collect, report and submit high-quality regulatory data, while offering them the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.

Across the entire drug development value chain, Instem solutions is on a daily basis meeting the rapidly expanding needs of life science organizations for data-driven decision-making, leading to safer, more effective products.

Instem supports its global roster of clients through offices in the United States, United Kingdom, Europe, Japan, China and India.

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