Case Study: Solution for cartridge failures on IMP delivery devices

SGS addresses cartridge failures during the Phase 1 IMP study to ensure a successful clinical trial.

A first-in-human, double-blind, randomized, placebo-controlled, Phase 1 study was undertaken to evaluate the safety, tolerability, reactogenicity, and immunogenicity of an Investigational Medicinal Product (IMP). The IMP was administered to participants with chronic hepatitis B by intramuscular injection with the help of an investigational device. The investigational device used single-use cartridges, in which the syringe containing the IMP was inserted.

Complete the form below to access our latest clinical trial management case studies.

First name *

Last name *

Company name *

Email address *

Location *

I would like to receive relevant communications from SGS.

I agree that SGS can use my data for the purposes of dealing with my request, in accordance with the SGS Online Privacy Statement. *

Key Challenge: IMP Cartridge Failures

Cartridge failures were experienced during the Phase 1 study for the IMP, with some devices showing an error message and not injecting the IMP.

Solutions and Outcome A Comprehensive Plan to Deal With IMP Cartridge Failures

SGS created a solution to address the cartridge failures. Sites were asked to send pictures of the failed cartridges to the device company. They were also asked to send the failed cartridges and system logs to the device company for investigation.

The SGS investigation showed a fabrication issue of one cartridge lot. It was decided to continue using the lot, but the site’s pharmacies were asked to prepare two doses at once so that in the case of cartridge failure, a second injection could be attempted right away, without the patient having to wait for the preparation of a new dose.

The investigation also showed that there were manipulation errors at the site. Any time a site manipulation error was detected, additional instructions were sent to all sites to avoid repetition of the same manipulation error.

In addition, for sites that had not started dosing patients, the CRA went to the site to witness the first injection, ensuring that correct procedures were followed.

A particular error that was detected in panel A, following the SGS solution, did not occur again in any of the following panels. Similarly, an error that occurred nine times in panel B and C1, following the SGS solution, only occurred once in panel C2.