More case studies
How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market
Rescuing a Global Biotech's Oncology Study with Cetuximab
How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries
Delivering Comparators for a Global Allergy Study
How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule
Sourcing Flu Vaccines for a Global Trial
A recent example of the flexibility and efficiency of CSI’s Quality team was their response to the unforeseen unavailability of a chosen warehouse for the storage of a country-specific product due to be supplied to one of our partners’ ongoing clinical trials. Due to unforeseen circumstances at the warehouse, the intermediate storage of the medication became impossible at very short notice. Since the re-supply date for the medication was in less than 10 days’ time, rapid action was required to maintain timely supply for the trial.
While it is critical to the success of any study to ensure that Quality standards are upheld and regulations followed, there is sometimes also need to be adaptable to respond to shifting priorities in ongoing studies. As such, CSI’s Project Management team reached out to our Quality team with viable alternatives to the original warehouse. The Quality team proceeded to adjust their working hours to facilitate immediate communication with the new warehouse located on the other side of the globe.
Having successfully gathered all documentation required, and after performing a full audit and qualification of the warehouse in just 5 days, the efforts of CSI’s Quality team ensured consistent supply of the product required for our partner’s clinical trial that was in progress and could not afford to be delayed. This was an excellent display of efficiency and collaboration between CSI and the new warehouse’s Quality teams.
A Quality Solution to Clinical Trial Supply
How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial
At short notice, intermediate storage of a medication sourced for a partner’s clinical trial was no longer possible at a specified warehouse
CSI’s Quality team adjusted their working hours to facilitate immediate communication with a new warehouse located on the other side of the world
All required documentation was gathered to perform a full audit and qualification of the warehouse in just five days, resulting in timely trial supply
Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements