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Genioo developed a comprehensive D&I ‘Playbook’ that played a key role in a leading global pharmaceutical company's clinical research programme and development cycle.


For a large pharma company, its growing desire to better serve underrepresented populations and build trust and confidence in drug efficacy in clinically relevant patients remained unfulfilled.

New FDA guidance sparked a renewed vigor to get ahead of industry trends and regulators and drive Diversity & Inclusion (D&I) in its clinical trials. The company felt ready to shift from just talking about D&I to taking action and making a difference. 


The scale and scope of Clinical Trials and Research & Development operations called for comprehensive D&I guidance, tools, and techniques. The company needed to address cross-functional D&I considerations and challenges throughout the development lifecycle.

As a trusted partner with experience in developing effective clinical operations playbooks, the company reached out to Genioo to help produce a high-quality, robust D&I playbook at speed. 


Our collaboration with the clinical operations lead, D&I champion, and key stakeholders across Research & Development deepened our understanding of clinical trial population issues — eligibility criteria, exclusions, contraindications, and underrepresentation. 

We mapped these considerations and challenges across study design, methodology, protocols, recruitment, participation, and reporting. And we embedded the tools and techniques to target a trial population mix reflective of the patients likely to take the drug if approved. We further outlined a stringent process to broaden trial eligibility criteria in line with clinical trial phases and drug safety protocols.


The company now has a clear and consistent approach to improving D&I in its clinical trials. It can use this guidance to embed D&I knowledge and understanding into the culture of its teams and the fabric of its clinical and business operations.  

Armed with the right knowledge and motivation, clinical teams can proactively drive D&I in clinical trials and champion health equity. And in doing so, they will strengthen reputation and relationships among employees, industry, regulators, and society, and more importantly, build public trust. 

To find out more about how we can support you to ensure diversity and inclusion in your clinical trials, get in touch today.

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