Situation: A global Phase 3, infectious disease study evaluating the clinical efficacy of a drug in patients with mild to moderate symptoms related to COVID-19 infection
The Success:
We stepped into a program that was struggling mid-stream and quickly assessed the issues, driving to a locked database and top-line results in a very short period of time. How were we able to do this?
- Leveraged our experience and insights to help us address the complexity of the clinical trial in the analysis plan by closely partnering with the Sponsor and working through all of the details of the protocol, SAP, and clinical trial operational execution to ensure that the Sponsor approached the analysis in a sound and defensible manner
- Assigned a very experienced and knowledgeable program lead to the project who was able to effectively drive the program execution while keeping the Sponsor informed of progress and involving them in decision-making and problem solving
- Provided quick and easy access to Rho’s Senior Leadership for consulting when the Sponsor was making important strategic decisions
- Adjusted our plans and timelines rapidly as situations changed which helped the Sponsor achieve their internal goals for a very important COVID-19 program
- Provided suggestions and guidance to the Sponsor when we felt that they were making decisions which could compromise the data or analyses and jeopardize their objectives. As the Sponsor said, “Not all vendors will do that. This was exactly what we needed in order for us to see that you were dedicated to our program and helping us to achieve our objectives and not just doing a job.”
This global study included 1200+ participants over 38 sites in three countries. As a result, drug development advanced one step closer to fulfilling an unmet patient need for those suffering from the pandemic.