Having created a clinical supply chain inventory management platform, SmartSignals Supplies, Signant identified a need for adaptive investigational product labeling as the pharma industry began to rethink established ways of working. The rethink has led to growth in direct-to-site and direct-to-patient clinical trial supply models and just-in-time packaging to accommodate advanced medicinal products.
“The global pandemic and other macro supply chain challenges have required the industry to think about labeling, printing, and production practices differently. Historical approaches mainly focused on long lead times to create multi-language booklet labels supporting a single trial. The focus today is much more on agile production, re-use, and postponement supply chain strategies where possible,” said Oli Cunningham, vice president of product management and supplies management at Signant.
Cunningham cites multi-protocol single panel labels, e-labeling, and a shift toward just-in-time labeling upon demand with in-line camera verification technology as examples of the evolution that is underway.
The changes are part of an attempt to address inefficiencies that can cause supply chain challenges and ultimately delay time to market. Specific problems include an increase in overall waste of drug due to the associated time with labeling and subsequent re-labeling and missed patients due to not having timely labeled supply at clinical sites.
Signant has responded to the changes by partnering with Loftware, the developer of a label and content management platform, to facilitate the seamless transfer of key master data in the end-to-end labeling process for sponsors or CROs,
“This real-time integration between the two systems enables joint customers to efficiently plan, design, and gain appropriate regulatory approvals for their clinical label supply chains in an efficient and secure manner while reducing the burden of manually transcribing key protocol components between two disconnected GxP systems,” said Cunningham.
Signant envisages the partnership empowering its customers to take advantage of enhanced regulatory control, direct booklet label design, and the advancement of in-line camera verification of labels.