Rezolute Optimizes Efficiency and Control with FSP Outsourcing

The Challenge: How to NOT be an ATM for your CRO.

Rezolute, Inc. (Nasdaq:RZLT), is a clinical stage biopharmaceutical company dedicated to advancing therapies for rare, metabolic and life-threatening diseases. Like many early-stage sponsors living on investor funding, they experience significant pressure to demonstrate that they receive the best possible value from their outsourcing partners. Based on previous and recent experience conducting and financing clinical studies Rezolute realized that employing a full service CRO can often lead to unexpected discrepancies of issues popping up either during or after the data cleaning has been performed. CROs often subcontract various functions, such as lab work, data management and/or biostatistics. Relying on CROs to manage and communicate all the study details and updates as they occur during a clinical study has led to data issues which ultimately caused unexpected and unforeseen timelines delays following completion of enrollment as well as additional costs due to the timeline delays. Communication failure and collaboration across vendors led to all these issues and in the end no one was happy. Realizing that no one person or even company can be good at everything, Rezolute having previous experience chose to implement a Functional Service Provider (FSP) model. The FSP model was chosen to get better outsourcing oversight, hiring key vendors to manage their area or expertise, and brought Rezolute to the center of the communication management across all supporting vendors. The approach met both clinical operations and financial needs.

The Solution: Own the relationships, own the contracts, and drive priorities.

Rezolute discovered that directly managing several vendors took no more resources than it did to manage a full service CRO. By hiring specialized CROs they gained deep experience and talent who actually worked on their studies and became a true extension of the Sponsor team. Their direct connection to key functions gave them knowledge of all details such as the impact of protocol changes or database migrations, providing the ability to better see and manage costs and milestones and the ability to scale up/down services and personnel as needed which helped control overall study costs. Rezolute saw other unanticipated benefits. Rather than following a centralized CRO’s processes, the FSP partners brought their expertise to help establish Rezolute-specific standards and processes and train team members.

The Outcome: Cost Controls, plus Improved Governance Over Their Clinical Trials.

While running clinical trials, every detail is rarely perfect. Rezolute chose to control their own data and overall management of the study by using different vendors for the clinical data, statistics and programming separate from the monitoring and management. With an FSP approach including Quartesian, Rezolute has been able to utilize and work with their vendors in terms of cross checking datapoints, study milestones and finding areas for improvement or where communication broke down. With Rezolute being the main point of contact for each of their critical vendors, Rezolute is first to know of any serious issues, able to run metric reports when needed to assess team performance and can support their vendors to escalate matters when issues or unexpected delays pop up. This set up has led to stronger team collaboration and communication as a whole.

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