How Oncology Biotechs Can Achieve Always Audit Ready Clinical Operations

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Tuesday, November 26, 2024

Discover how companies can maintain a constant state of audit-readiness using lean methodologies and strategic tools.

In this webinar, Julie Martin, CEO, Scimega, examines how a niche Canadian oncology clinical research organization (CRO) deploys the ‘silver bullet’ that keeps organizations always audit-ready. She will focus on how to maintain audit readiness with a robust team foundation; how Lean methodologies and tools are effective in doing this; and how other partners that collaborate in operations fulfillment can be integrated into always audit-ready processes.

Register for this webinar today to understand how an audit-ready organization should function with valuable input on how audit processes can be streamlined and continuous compliance with regulatory requirement can be ensured.

Attendees will also get access to the white paper “Expert Guidance to Key Advantages of Canadian Regulatory Landscape,” which focuses on how to navigate the regulatory landscape.

Speaker

Julie Martin, Scimega

Julie Martin, MSc, Lean Certified, CEO, Scimega

Julie Martin is a 17-year industry veteran who has led Scimega as CEO for five years. Her passion for Scimega’s business and team stems from knowing its expert oncology clinical development services adds distinct value to industry stakeholders at a time when it’s needed most.

As CEO, Julie’s vision is to secure the company’s long-term success by leveraging her in-depth industry expertise and business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership and collaboration with the managing Board of Directors combined ensure the business excellence upon which Scimega has built its reputation.

Julie plays a vital role in promoting Scimega’s expertise and showcasing Canada’s attributes as a formidable partner in global oncology drug development with an evolving lean methodology.

Message Presenter

Who Should Attend?

This webinar will appeal to:

  • Clinical operations team leaders
  • Small to mid-size biotech and biopharma companies
  • Those managing complex oncology clinical studies
  • Manager/Associate, Clinical Operations
  • Assistant Director/Director/Head/Vice President, Operations
  • CEO
  • Chief Medical Officer

What You Will Learn

Attendees will learn about:

  • Adopting a lean team approach to audit readiness
  • Using lean methodology and tools to optimize audit readiness
  • Identifying the key strategies, or ‘silver bullets,’ for sustained audit readiness
  • Understanding the crucial role of collaborators in achieving and maintaining audit readiness

Xtalks Partner

Scimega 

Scimega is a niche Canadian oncology CRO acting in Canada within the context of global cutting-edge oncology trials sponsored by mid-size and smaller biotechs. Skilled in collaborative vendor teaming, Scimega guarantees sponsors the quickest site start-up and highest patient recruitment rate, without sacrificing premium quality data.

With an optimal operations design robust enough to address an ever-changing clinical trial landscape, Scimega’s team of Lean Coached oncology experts go above-and-beyond to provide: Local, full-time, permanent hires for exceptional staff quality; An extensive network of Canadian Investigator Sites that frequently emerge among top enrollers, and are activated 50% faster than average for global studies; Optimal site engagement to maximize quality, timely data entry and query resolution; Robust and Lean Scimega methodology and processes are supported by current technology to keep every trial this CRO monitors on the Lean trajectory.

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