Clinical trials often involve numerous cross-border shipments. Combined with the complexities of different international regulatory bodies this can be very time consuming, resulting in further delays for your clinical trial. Understanding the logistics behind shipping is essential when it comes to distributing your clinical trial drug product internationally and on time. Whether your drug is being distributed to the country…
Packaging is an important component of successfully getting a drug ready for its clinical trial. While there are a number of regulations surrounding drug packaging and labeling, packaging specialists have one of the most creative roles in the clinical trial industry because of unique and specific packaging needs. In this article, we break down the five most important aspects of…
With Canada’s legalization of cannabis now here, it’s important for the clinical research community to stay informed on what legalization will mean for cannabis regulations in clinical drug trials. With terms like decriminalization and phytocannabinoids coming up in everyday conversation, it may appear that legalization will further complicate the pre-existing clinical trial regulations but – spoiler alert: developing treatments that…
In order to successfully run clinical trials, you will need to be able to successfully recruit subjects. It is critical to the success of your trial to implement strategies for subject recruitment and retention. At the subject level, participation is voluntary based on informed consent. An essential element of the informed consent process is ensuring that subjects are provided with comprehensive…
Before we can address the challenges in the clinical trial supply chain, we need to identify what they are. Based on our research and experience, we’ve come up with the top 4 challenge areas we see. Blinded Coordinators In order for Clinical Trial Coordinators responsible for providing randomization codes for a trial to do their job, they need to be…
Risk-awareness is a critical component of successful clinical supply management; you cannot fix the problems you don’t know about. We see clinical supply professionals overlooking the same key risks time and again. Let’s address them now. Expiry dating One of the biggest impacts to the success of clinical supply management is expiry dating, particularly of the product itself. As formulation…
Some degree of drug waste at your facility is inevitable, but it is worth the effort to try to reduce drug waste as much as possible. The drawbacks of drug waste include: cost of over-purchasing, expired, unusable drugs, unused drugs at the site level, and the environmental impact of destroying unused drugs. However, eliminating drug waste is a challenge. There…
Determining whether to conduct clinical trials in-house or outsource the task to a contractor requires careful consideration. We must weigh the pros and cons of expenditures versus potential advantages. In-House Trials Pros: More flexibility Increased in-house knowledge Lower potential for communication issues Cons: Possibly more expensive Requires time and resources to develop in-house expertise If you decide to conduct clinical…
The Supply Chain is often an afterthought when managing Clinical Trials. Where the devil is in the details, having a lack of resources to manage your Clinical Supplies can result in a detrimental loss to your Clinical Trial Study. It’ll likely result in a negative impact to your bottom line and your drug won’t go to market as planned. At…