By Keith Wright, Director – Solutions Consulting, Strategic Accounts @ Florence Healthcare

Its clinical research trade show season and 5 themes are becoming trends that require attention across the value change. 

• Emerging themes highlight the necessity of inspection readiness and the adoption of a risk-based approach, underscoring a proactive commitment to compliance and quality management. 
• There is also a recognition of how pivotal information in our industry is. However, there is still a tech literacy gap among many industry players. 
• The human element surfaces as a central pillar in this narrative, emphasizing the critical nature of face-to-face interactions and the growing depth of sponsor-vendor relationships. 
• As we explore the experiences of pharmaceutical giants, a call to prioritize a site-first approach in tech adoption echoes. 
• Simplicity and value for both sites and patients remain the overarching theme. 

The post-pandemic era has started a transformative shift, dismantling traditional barriers and propelling the industry towards patient-enabled technologies and the collaborative integration of artificial intelligence in drug development. 

Let’s explore these themes a bit further. 

Inspection Readiness and Risk-Based Approach: 

The overarching theme is the critical importance of being inspection-ready and adopting a risk-based approach across various aspects of clinical research, from quality management to site selection, vendor management, audits, monitoring, and beyond. This focus ensures a proactive stance in compliance and quality.

• For Sponsors, embracing a risk-based approach in all facets of clinical research is like putting on a superhero cape. It’s not just about ticking boxes; being ready for inspections and strategically managing risks isn’t just a compliance necessity.  Site oversight and real time access to their reg files gives confidence to Sponsors in case of an inspection. It’s a powerful way to elevate the overall quality and success of the clinical research journey. 
• For sites, the key takeaway is that embracing inspection readiness and a risk-based approach isn’t just about following rules—it’s about doing your part to protect the integrity and quality of the research.

Data as Currency and Tech Literacy Gap: 

The recognition that “data is our currency” underscores the value placed on information. Simultaneously, there’s a challenge highlighted—many tech companies lack awareness of the clinical research industry, regulations, and workflows, emphasizing the need for improved tech literacy within the field.

Human Element and Sponsor-Vendor Collaboration: 

Acknowledging the human element in all processes is a key takeaway. Face-to-face interactions are deemed critical, and the growing frequency of virtual and in-person meetings strengthens sponsor-vendor relationships. Vendors are advised to listen and collaborate closely, sharing their SOPs for effective oversight.

Tech Adoption and Site-Focused Innovation: 

Pharma companies, though often perceived as slow in adopting new technology, are urged to prioritize a site-first approach for successful innovation. Big Pharma emphasizes simplicity and value for both sites and patients.

Post-Pandemic Innovation and AI Integration: 

The post-pandemic era ushered in a shift towards patient-enabled technologies and a reevaluation of traditional operating models. The takeaway is the need to break down established barriers and embrace innovative technologies. AI, particularly discussed in the context of accelerating drug development, is seen as a collaborative tool rather than a competitor, emphasizing the importance of learning to work with AI.

These takeaways collectively paint a picture of an industry evolving towards a more tech-savvy, risk-aware, and patient-centric future, guided by lessons learned from both specific experiences and broader industry trends.