Challenge
The client needed to conduct Clinical Usability Sub-Studies for two biosimilar prefilled syringes delivered through intravitreal injection to support an FDA Biologics License Application (BLA). The primary challenge was meeting compressed timelines while ensuring regulatory compliance and quality data collection.

Solution
We implemented a comprehensive approach to meet our client's needs through efficient execution of two Clinical Usability Sub-Study Protocols:

• Effective Communication Strategy: We established regular check-ins with the CRO and client, kicking off during protocol development and continuing through reporting, to ensure prompt communication and timely resolution of any project roadblocks. Our team also provided updates on usability observations from patient treatments within one day of each visit, allowing for prompt updates to the client’s management and real-time decision making. 

• Flexible Implementation Model: ClariMed deployed multiple study teams across the country to visit clinical sites concurrently. This approach supported nimble scheduling of patient treatments, decreasing time to complete enrollment while still maintaining quality standards. We also expedited sub-study reports for seamless inclusion in the Clinical Study Report. 

• Quality-Focused Compliance: We supported rapid Site Initiation Visits and met with sub-investigators and their staff at each clinical site on Day 1 to enhance compliance with the Clinical Study Protocol. Our real-time review of study records by our Quality Assurance team ensured high-quality data collection that aligned with the Trial Master File Quality Plan without imposing unnecessary delays on the overall study timeline.

Results
Our approach delivered significant value to the client, including:

1. On-Time Delivery - Clinical Study Reports were completed within the tight timeline with no last-minute surprises in the results

2. Regulatory Success - The client was able to submit the clinical usability study data with their BLA on time, meeting organizational goals

3. Operational Efficiency - Our flexible model reduced overall study duration without compromising data quality

Conclusion
Through our streamlined approach to clinical usability studies, we helped our client navigate complex regulatory requirements while accelerating their time to market. Our ability to deploy flexible resources, maintain clear communication, and ensure regulatory compliance proved critical to the project's success.

Learn more about ClariMed Human Factors & Usability research.