CalCog’s established returns for redistribution procedure aids sponsor in keeping pivotal trial on time and in budget.
A clinical-stage pharmaceutical company with a novel therapeutic for a common yet debilitating condition discovered that product distribution for its Phase III clinical trial became severely out of line with patient enrollment, risking extensive trial delays. The sponsor’s internal clinical supply team had programmed the interactive response technology (IRT) to distribute product based on anticipated enrollment activity at each site. Due to lagging patient enrollment in specific geographical regions, they needed to adjust its patient enrollment strategy.
The sponsor added numerous trial sites to enroll the required number of patients. Because of this, their product distribution plan (based on initially anticipated patient enrollment) became inaccurate—some sites were significantly overstocked, while others were understocked. As a result, they did not have the necessary product allocation per treatment group.
THE CHALLENGES
The sponsor’s product was misaligned with the ultimate structure of patient enrollment after adding clinical trial sites to reach the required patient enrollment.
Further challenges of this Phase III clinical trial included the following:
- Since additional drug products were not available to create new kits, returns needed to comply with strict GMP standards.
- The blinded kits needed to be redistributed while maintaining randomization integrity.
- To avoid study delays and negative impacts on patient care, rapid kit redistribution was necessary.
- The product redistribution plan had to adhere to all compliance requirements.
OUR SOLUTIONS
CalCog’s ability to solve this sponsor’s challenges rested in our extensive experience developing creative solutions within regulatory parameters.
The critical tool for addressing this challenge resided in CalCog’s electronic Quality Management System.
Specifically, we leveraged our proprietary returns for redistribution procedure, a thorough, step-by-step process for managing clinical site-to-GMP facility, or clinical site-to- clinical site, product redistribution.
The sponsor decided the best approach was to identify the sites with significant overstock and return that product to CalCog’s GMP facility in Bastrop, Texas, for redistribution. The solutions the CalCog team developed and executed included the following:
- CalCog leveraged our proprietary, optimized returns for redistribution procedure to direct the sponsor and make critical decisions in collaboration with them.
- CalCog deployed return kits to the clinical sites— including temperature-controlled shipping containers, packing materials, temperature monitors, and detailed packing and return instructions—allowing on-site clinical research associates to assist in preparing the product for a safe return.
- The documentation provided for each package maintained the proper chain of custody.
- Upon receipt, CalCog’s receiving and quality control teams immediately opened and inspected packages and documentation.
- CalCog’s quality assurance team collaborated with the sponsor to manage discrepancies or packaging damage.
- Redistributed kits remained properly blinded.
- Throughout the redistribution program, all compliance requirements were met.
PROGRAM OUTCOMES
Rapid product redistribution to the clinal sites facilitated alignment with actual patient enrollment.
Costs remained within established budget constructs.
Manufacturing and packaging of additional bright stock, costly study delays, and impact on patient care were avoided.
All FDA and other applicable regulatory requirements were adhered to.
“CalCog’s established and vetted clinical product redistribution procedure was incredibly comforting, and it provided a lot of confidence that the effort would be handled seamlessly. To minimize future challenges of this nature, we started consulting with CalCog’s clinical supply planning experts at the beginning of our study, and this collaboration has been incredibly beneficial.”
– Vice President, Clinical Operations, Pharmaceutical Innovator
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