LBG’s assistance and support enabled a client to complete two Phase 2 clinical studies and advance their vaccine platform.
Challenge:
Due to its small size, a clinical stage vaccine developer in the Midwest needed support in the following areas:
- management of a government-sponsored project
- clinical trial support services
- clinical study oversight and management.
Comprised of fewer than a dozen employees, the client relies significantly on outside assistance to manage their internal and external projects. They needed LBG to act as an integrated member of their team and fill the gaps that they had in personnel in order to support these areas as they executed two Phase 2 clinical studies.
The client engaged LBG because we helped them develop their winning proposal.
Solution:
Our response included standard LBG support of government contracts, such as compiling quarterly and annual reports for the government and completing the minutes and tracking activities for the team check- in calls. We also led efforts to identify testing labs for measuring responses to their vaccine. This included drafting the RFPs for this work, identifying organizations that could respond to the RFP, distributing the RFP, responding to questions, and collecting the RFP responses.
In addition to the routine project support (quarterly reports and program management activities, etc.), we helped the client redesign their goals for their second Phase 2 study based on the results of the first Phase 2 study, drafted a synopsis for the revised clinical protocol, helped the client identify clinical sites to support the proposed study, and worked with them to coordinate the execution of the study.
The support we provided was collaborative, and we worked with the client as partners to accomplish their program goals. Our support and assistance covered the three years of the funded contract.
Results and Impact:
With our assistance, the client was awarded a contract that supported two Phase 2 clinical studies to determine the dose and preliminary effectiveness of the vaccine that they have under development. Our support enabled them to complete both clinical studies within the timeline—despite the need to redesign the second study—and they were able to advance the development of their vaccine platform. In addition, they were also able to obtain follow-on funding from the agency based on the progress they have made on this initial contract.
