Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.
Successful clinical trials require accurate demand forecasting, efficient distribution channels and a secure supply chain strategy. Find out how Almac Clinical Services helped one sponsor implement an optimized clinical supply strategy that resulted in an uninterrupted clinical trial and reduced costs.
Sharp Clinical Services provided a solution for a pharma clients that required a new oral formulation of their product. Multiple active ingredients created a complex manufacturing process combined with a requirements of 8 different batches required expertise of Sharp's Analytical and Formulation Development teams.
How a diagnostics startup drastically reduced timelines and costs, and easily shared data across dispersed sites.
Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.
Premier Research was given a tight timeline of less than four months from delivery of the final protocol to first patient in. With proper site selection to accommodate the needs of a fast start-up along with open and frequent communication with the principle investigator and the project team, they were able to meet this timeline.
CRO helps company overcome early patient screening failure rate of 70 percent as well as assisting with instituting new protocols and renegotiating contracts as the study experiences and major change of direction.
After lengthy recruiting process and a five year long clinical trial spread across more than two dozen sites, sponsor calls study results “an unexpectedly huge step forward” in overcoming the limited efficacy of current treatments and continues partnership with CRO.
Failure to transmit data collected effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.
Clinical labeling of biological products, operating within ultra-low temperatures can present unique challenges. Read this case study to find out how one biotechnology company built an effective strategy to label temperature sensitive clinical trial material.
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