When you think of security you might imagine security cameras, alarm systems, and guards. But security is so much more than that, especially for clinical trials. Security in clinical trials is more important than ever with the rising necessity of virtual trials because of the COVID-19 pandemic. In this blog post we’ve highlighted the top 5 security considerations you need to keep in mind when conducting your clinical trial.
Data
There can be a lot of data associated with your clinical trial including patient information, product development, and trial results. All of the data associated with your trial must be secure both for privacy, and to prevent the loss of these important records. If your information is in a physical documented form it may be beneficial to consider moving it into a digital platform to maintain the integrity of the records, save physical space, and make collaboration between teammates easier. One resource to accomplish this daunting task is to partner with a records scanning organization such as Bay Area Records.
Temperature
The temperature that your drug is stored or transported at can be crucial to ensuring the integrity of the treatment. For many treatments, a change in temperature can mean that it is no longer effective or even harmful to trial participants. Whether your product is stored at ambient, refrigerated, frozen, or ultra-low frozen, monitoring this can be stressful, time consuming, and costly. A generator can mitigate risks of your products not being maintained at the proper temperature in case of a power failure. Also, electronic monitoring systems can allow you to monitor temperature of your drugs 24/7 and even alert you to any dangerous changes.
Facility
Not only do you need to monitor the temperature of your products, but also ensuring that they are secure from theft or tampering is equally important. A poor security system for the storage facilities of your products can create a costly disaster. The facility that your drug is stored in should be electronically alarmed to prevent potential loss of the products through theft or tampering.
Protection from Contamination
Your drug should be protected from contamination wherever it is manufactured, stored, and distributed to ensure the integrity of the product as well as the health and safety of your clinical trial participants. The lessons that we have learned from COVID-19 has also made organizations hyperaware of the need for personal protective equipment to prevent the spread of any virus or illness to these patients, especially patients that are at high risk for infection. To mitigate the risk for product contamination any staff handling the materials must be properly trained in the use of proper health and safety equipment and best practices. The facility that these drugs are stored in must also be free from contaminants, regularly sanitized, and if necessary have a clean room available. The use of a GMP compliant partner can be the solution to ensuring the safety and quality of your investigational product.
Distribution
When you ship your clinical trial products, it is important to certify that it arrives in good condition, with proper handling and temperature controls. Couriers can be a trusted partner in this regard and are becoming increasingly important with the elevated demand for direct-to-patient trials. Distributors are also adapting to the needs for contact free deliveries because of COVID-19 and may change the way drug distribution and delivery is handled in the future.
Disposal
What do you do with leftover drug product and data at the conclusion of your clinical trial? Some data and drug should be destroyed appropriately and some should be reported to other authorities, like the FDA, or archived for the required period of time. How you handle these last steps can mean seeing further product success, or irretrievable results.
The need for clinical trial security is more important than ever in these times of change to the medical research industry. COVID-19 has presented new needs to ensure the security of clinical trials in many areas. Research organizations and professionals have begun to adapt these processes to better suit the shifting requirements of the industry. New government processes and best practices have been established to ensure the safety of patients and researchers alike. Always make sure you stay up to date on the relevant processes for your clinical trial and consult with a clinical trial logistics professional if you are unsure.
