2024-JULY F2F ASQ O E (Section-701) Monthly Meeting

Quality in clinical research is essential to ensure patient safety. It is not just a documentation exercise. Without a quality approach, the wrong patient may be dosed and the patient may experience a serious adverse event as a result. It is therefore imperative that we as a research community and industry dedicated to solving unmet medical needs continue our quest for quality research. Previous methods were heavily dependent upon manual processes and self-reported events. Current methods are hybridized versions of automated and manual processes. The future with AI may be able to further ensure clinical quality, but how can will employers and employees utilize AI in clinical quality and what level of discipline will need to be included in scientific product development and supporting business processes?

OUTLINE

1. Why is Quality important in clinical research?

2. What does clinical research Quality consist of?

3. Who is responsible for quality in clinical research?

4. How can one ensure clinical research quality?

5. Previous methods (show process diagram)

6. Current methods (give hybrid and DCT examples)

7. Future of quality… how can AI help us? Explore a hypothetical case study.

a. Employer/employee expectations

b. Clinical research process with opportunities for AI

Raju Joshi is a co-Founder of Clinical Partners Group, a boutique health services and life sciences strategy and operations firm. Raju is responsible for leading our life sciences practice in which she focuses on clinical, regulatory, and reimbursement affairs.

Prior to starting up Clinical Partners Group, Raju held various executive leadership positions at Amgen, Inc., Medtronic, Inc., Deloitte, and SetPoint Medical Corporation. She brings over 31 years of healthcare, life sciences, consulting and leadership experience.

At Medtronic, she was responsible for a team of Clinical Researchers, Quality, Regulatory and Reimbursement professional who focused on inpatient glucose monitoring devices. She was responsible for running early and late development clinical trials for the continuous glucose monitoring sensor and was involved in the clinical development of deep brain stimulation and cardiovascular programs.

At Amgen she chaired a team of scientific directors and executive directors including physicians, pharmacists, nurses, biomedical engineers, and software engineers, involved in combination product development and digital health products. She has served as an advisory board member to global oncology IVD and neurology clients, coauthored NIH grants, and has been an invited speaker to various conferences on the topic of clinical operations, regulatory, reimbursement affairs and AI.

Many companies are unsure of how to begin implementing Lean and / or Six Sigma tools and techniques in their companies. Statistics and Six Sigma concepts intimidate many, but they don’t have to. Many companies have metrics they collect, but don’t really use to guide their improvement initiatives. This session will help every organization down their Six Sigma path.

• Start with the 5Ss
• Lean & Six Sigma definitions / applications
• 5 steps to a Lean program
• Benefits of Lean & Six Sigma

Jane founded purple link in 2015, sharing with clients there’s a better way to obtain value through the supply chain. Clients find dollars leaking through their supply chains, draining the bottom line, and uncover risks lurking in the supply chain that emerge at the worst possible time. With purple link, clients develop skills to use with processes and tools to reclaim those dollars, return them to the bottom line, monitor and manage risk, and sustain savings year over year. An engineer with an MBA, Green Belt, CPSM and CPSD certifications she’s writing her first book to share with other practitioners.

In addition to running her business, she teaches Operations and Supply Chain Management courses in the California State University system and serves on the advisory board for the Operations & Supply Chain Management program at CSULB. A consultant, speaker and author, she offers monthly Dynamic Dialog webinars and conducts workshops on a variety of topics. Her first book is due out in 2024.

Host or Publisher ASQ Orange Empire Section 0701