Clinical Trial Packaging
In the highly regulated pharmaceutical industry, clinical trial packaging is one of the most demanding and critical aspects of drug development. Clinical trials, as the final step before market approval, require precision and compliance with rigorous standards. The success of a clinical study hinges not only on the drug itself but also on the clinical trial supplies, including the packaging, which plays a crucial role in maintaining the integrity and accuracy of the trial.
Child-Resistant Packaging for Clinical Trials
Our clinical trial packaging is designed with exemplary child-resistant features, ensuring that our solutions meet the stringent safety requirements of the Consumer Product Safety Commission (CPSC). Keystone offers packaging solutions with F=1 child resistance, the highest designation possible, providing unmatched safety for clinical trial materials.
Promoting Patient Compliance and Medication Adherence
Another key aspect of successful clinical trials is ensuring patient compliance with dosing regimens. Our clinical supply packaging solutions are designed to improve medication adherence, a critical factor in evaluating the efficacy of new drugs. Keystone’s packaging can include calendarization features, helping patients take the right dose at the right time, which is crucial for both compliance and study accuracy.
Electronic Compliance Monitoring for Clinical Trials
Our experience with helping sponsors add technology to monitor medication adherence in clinical trials dates back to 2005. For studies that require precise monitoring of patient adherence, Keystone offers advanced packaging solutions such as the Key-Pak® and Eco-Slide RX 3.0® paperboard blister packs. These packaging options can incorporate electronic compliance monitoring, providing real-time data on medication usage. This data can be wirelessly transmitted for further analysis, offering pharmaceutical companies’ valuable insights into the drug’s performance. Real-time adherence data vs. patient reported dosing in diaries has proven to carry more weight in discussions with FDA.
Keystone’s clinical supplies packaging solutions also can spearhead documentation initiatives. For clinical trials where dosing data must be precisely recorded, both the Key-Pak® and Eco-Slide RX 3.0® paperboard blister pack solutions can support this task by incorporating an electronic module and printed sensor grid, which remain invisible to the patient while providing valuable clinical trial insight. This hidden technology, developed in collaboration with Information Mediary Corporation, records the time, date and location when a dose is removed from the blister package. The data can then be retrieved wirelessly which you can then use in clinical trial research.