Comprehensive and Flexible Partnership to Support Rescue Study 

The client’s goal was to find a partner to help secure a U.S. Food and Drug Administration fast-track designation and a Biologics License Application (BLA) submission. As the client’s needs grew, so did Catalyst’s involvement. Despite the ongoing, strong, and collaborative relationship with Catalyst, the client outsourced its entire global study to a large contract research organization (CRO). The client experienced timeline, staffing, and cultural fit issues and returned to Catalyst. The client has become a long-term partner after its experience with the large CRO during the asset’s development. The client expressed the need for a nimble and responsive, quality partner, especially regarding team stability, which Catalyst delivers. 

 Catalyst Flex approaches the client’s requests with an entrepreneurial spirit, evolving our team and solutions to align with the client. To solve for the client’s needs, Catalyst

• Designed and executed a global safety oversight model to oversee the case processing of safety data received from the clients’ sites globally
• Worked collaboratively on the timely distribution of expedited safety reports to the client’s CRO vendors within the Asia-Pacific region and North America for onward submission to the respective regulatory agencies
• Mindfully focused on team stability, quickly addressing with the client any misalignments, and collaboratively ensuring necessary changes
• Created system-agnostic processes to adhere to the client’s technologies ensuring efficient electronic data collection across 116 sites

The client’s trust in Catalyst has provided a strong, ongoing partnership. The client understands Catalyst adapts and provides the functional and program oversight as needed. Our current engagement includes expanded access programs and safety services across several projects. Our quality-driven safety team excels in its diligence and high standards in data entry and narrative writing, even adapting systems and processes to address client-managed system issues. 

Empathy, intentionality, trust, flexibility are a few of the Catalyst company values exhibited throughout this partnership, which has resulted in repeat engagement.