Case study

Assess safe and effective use of pediatric medical injection kit

A pharmaceutical company required a validation study to determine if the preparation and administration of an injection kit requiring the reconstitution of a pediatric medication was safe and effective.

Challenge

The manufacturer asked us to determine if nurses could prepare an injection device and reconstitute the drug for a clinical trial.

We executed every stage of the project from protocol writing to recruitment of a hard-to-recruit population (clinical trial pediatric nurses) to writing the validation report.

Approach

The validation study included HCP training, done by our on-staff RN to demonstrate techniques, a 24-hour decay, and a 60-min validation session, during which participants had to prepare and administer two doses of the kit.

Outcome

We evaluated and updated their risk assessment (uFMEA), aligning with previously submitted documents, while identifying new risks and user paths for the redesigned equipment.