Home > CRO Services > Pharmaceutical Case Studies > Clinical Trial Support
Pharmaceutical Case Studies
Our experience ranges from very large pharmaceutical companies to emerging startups. This is a key reason to consider Cambridge Biomedical for your sample testing needs.
Data integrity, patient sampling and sample management are at the core of your project. Cambridge Biomedical's expertise will provide you with timely, accurate and consistent results.
Clinical Trial Support– Phase IV
The Client
The client was a major biopharmaceutical company that was about to initiate a Phase IV clinical Trial. The clinical trial required patient specimen processing using a complex HPLC method from the original FDA submission package.
Technical Need
The client's senior research scientists' ability to continue their research was hampered significantly while they were required to run patient samples on this assay. Due to the complexity of the original HPLC method, the assays required approximately 61 hours to complete, resulting in low sample throughput and poor efficiency. The client wanted to transfer this complex and labor intensive HPLC method to a reliable CRO that could seamlessly integrate the transfer, validate the protocol, and then process patient samples in a GLP environment.
Cambridge Biomedical's Service
We selected two senior scientists to evaluate the protocol and craft a Technology Transfer Plan. The resulting project plan included a direct liaison between the client and our project team, qualification and validation of custom laboratory instruments. We also provided the direct involvement of our Quality Assurance Unit to ensure integration into their Document Control System.
Results
Cambridge Biomedical successfully and seamlessly brought the test online, aggregated and processed patient specimens, and provided the client with the necessary trial data for this Phase IV Study. This enabled the client's senior scientific staff to focus on strategic issues associated with post-commercial monitoring efforts.
Other Pharmaceutical Case Studies (CRO):
