Clinical trial site engagement

Project Lead Rene Limacher , VP Client Service US

Vision

A leading global pharma needed to empower clinical teams with a highly structured and cross-functional approach to clinical trial site outreach to foster a goal-oriented mindset, strengthen its brand, deepen site engagement, and drive up study enrollment.

Challenge

• A recent change from a 100% CRO outsourcing model for clinical trial management to in-house had led to different levels and approaches for site engagement.
• Following a pilot of a new approach with an Oncology trial to improve site engagement, it needed to enhance the approach with best practices, a playbook, and training materials to roll it out to additional study teams across multiple therapeutic areas.

Solution

The cross-functional clinical team partnered with Genioo for its extensive capabilities in clinical trial process excellence and codifying highly effective playbooks. Together we enabled better study participation through:

• a thorough assessment of the existing capabilities and tools, interviewing clinical study teams across multiple therapeutic areas, to find out what was working and what could be improved.
• designing workshops with client teams to share best practices on communication, relationship building, and site-specific expectations, and to align on tailored strategies and a coordinated approach for interacting with trial sites in a site-centric way.
• the co-development of a comprehensive playbook and toolkit for site engagement, providing clinical teams with a systematic approach to foster more collaborative, productive, and structured interactions.
• a streamlined data collection tool for site interactions and training for gathering quality insights to proactively identify and address recruitment challenges
• well-designed training materials and multiple workshops for eight study teams to train them on the essential knowledge and skills required for successful engagement with clinical sites.?

Impact

• The program enabled roll out to eight study teams across multiple therapeutic areas.
• Effective guidance, tools, and training set teams up to deliver improved site satisfaction, timely and efficient enrollment, and faster clinical operations.
• Efficient, accurate collection of interaction data saved time and resources and enabled real-time insights for proactive engagement.

"Site engagements are going strong. Teams are working well together, and it's given them what they need to move forward faster," Senior Director, Clinical Operations

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