Clinical trial supply management (CTSM) involves all the processes, such as planning, forecasting, procurement, manufacturing, storage, and distribution of clinical trial supplies in an efficient manner. This ensures that the appropriate clinical trial supplies reach clinical trial participants at the right time and in accurate condition. CTSM is a crucial part of running clinical trials…
We often hear this common concern from clinical trial managers: "We need a comparator drug from a single batch, and we can’t find it anywhere." Recently, we received a query from our client for a prostate cancer drug approved by the US FDA in 2023. Our client urgently required 300 packs from a single batch,…
Blood cancer affects millions of people worldwide, creating a challenging situation. A study predicts that in 2025, 66,890 new cancer cases and 23,540 cancer deaths will occur in the United States due to leukemia.
Recently, a few clinical trial sponsors approached us because they were facing a challenge in distinguishing between a genuine and counterfeit pack of an Immuno-Oncology Drug.
Decentralized Clinical Trials (DCTs) have transformed how clinical trials are conducted. This makes the clinical trial process more flexible and patient-friendly. This minimizes the requirement of participants to visit a trial site frequently. DCTs use technology to manage trials at remote locations with high efficiency, effectively managing clinical trial supply at different locations.…
Imagine a scenario where your clinical trial team orders a reference-listed drug with an approved shelf life of 24 to 36 months. However, when it reaches a clinical trial site, you have an RLD with less than 12 months to use.
Case in Point
Pertaining to a recent case involving an immuno-oncology blockbuster. Despite its…
Comparator drugs play a pivotal role in determining the quality, efficacy, and safety of the generic drug. It acts as a standard drug that will be used to compare the generic copies. It is essential to source the right comparator drug from genuine manufacturers, as there are many challenges in this process. Comparator sourcing can…
Bringing a new drug to market is one of the most complex and consequential undertakings in science. The drug development process typically spans 10 to 15 years, requires over $2.6 billion in investment, and involves thousands of researchers, regulators, and clinical trial participants before a single treatment reaches patients.
And the odds are not in…
The drug development process is quite complex, consisting of numerous steps. This includes discovering the drug, developing dosage forms, conducting research, carrying out clinical trials, seeking approval, and commercializing the drug. Drug development processes also require adherence to authorities like the FDA (Food and Drug Administration) and EMA (European Medicines Agency).
This streamlined…
Managing the storage, distribution, and supply chain of pharmaceutical products requiring special storage conditions is very crucial. This stage ensures the integrity, efficacy, and safety of pharmaceutical products for marketing, as well as products that are to be used for clinical trial supply. Efficient cold-chain management is needed for shipping pharmaceutical products from manufacturers to…
