Key-Pak is the most widely used child-resistant package in clinical trials and exceeds all current industry requirements. Since 2003, more than 25 million Key-Pak units have been produced around the world.
The benefits of Key-Pak include:
SPEED: Our business model takes into account the often short lead time requirements of the clinical trial industry.
FLEXIBILITY: Key-Pak can be customized for size, pill-count, dosing
regimen, and blister material. If you have a single pill per dose, or
multiples pills; tablets or capsules; PVC, Aclar or Foil blisters; heat-seal or pressure sensitive adhesive, Key-Pak can fit your study design.
COST-EFFECTIVENESS: As a two-ply paperboard solution, Key-Pak uses a minimal amount of material. This design also runs faster than 3-ply and multi-component package designs. The total-delivered-cost of the final product is much lower compared to other carded blister solutions.
COMPLIANCE IMPROVEMENT: The calendar format of Key-Pak promotes patient compliance with the prescribed dosing regimen. Studies have shown a direct correlation between carded blister packaging and patient adherence.
When a clinical trial will involve the home-use of solid, oral dose medication (or when trials will be conducted either entirely or partially in the U.S.) the new, investigational drug and its comparator should be housed in packaging that incorporates an approved child-resistant feature – at least for the portion of the trial conducted in the U.S.. It is also important to consider if there are advantages to conducting the entire trial in the same packaging.
Regulations for Clinical Trials Conducted in the U.S.
The following regulations apply to clinical trials packaging for home use in the U.S.: