Our previous article summarized the importance of people, process and technology coordination to successful clinical study logistics. In this article, we look at how logistics performance contributes to a study’s outcome, and how to measure that performance.
Overall, the success of a cell or gene therapy clinical trial can be measured by its benefit to the patients involved. Did they receive the therapies they needed, and did the therapies have the hoped-for results?
As logistics providers, of course, we can’t control the effectiveness of therapies, but we can give them the best possible chance of success. Our job is to make sure those samples and therapies arrive where they are needed, when they’re needed, and in the same condition they left the lab or collection site.
Measuring logistics performance is important to everyone involved. For the logistics provider, metrics measurement helps identify areas for improvement and refine future performance.For the trial sponsor or clinical research organization (CRO), metrics measurement hones in on specific reasons for trial delays or other unwanted results. It also helps in deciding whether you want to partner with that logistics provider again.
Finally, reviewing the evidence of past performance of potential logistics partners before you engage them increases the probability of successful logistics for upcoming trials.
Below are six indicators of successful logistics performance:
- Minimizing temperature excursions
- Maintaining quality standards
- Optimizing production
- Ensuring on-time delivery of product
- Minimizing overages and shortages
- Maintaining regulatory compliance
Logistics performance can affect the outcome of every aspect of clinical trials, from lab to therapy delivery to study costs and regulatory approvals.
For more information on how your logistics partner can help maximize the success of cell and gene therapy trials as the products move towards commercialization, please download our e-book - Tomorrow’s Medicine: Curing One Patient at a Time.