Almac Clinical Services, a member of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the launch of its enhanced Label Approval Solution (LAS) – a fully compliant and validated system providing sponsors with an end-to-end solution to manage their clinical labels more effectively from Protocol to Print.
As part of its customer experience initiative with an ongoing focus to provide customers with flexible, innovative and efficient processes, Almac’s enhanced LAS will enable sponsors to have access to the latest online technology thereby streamlining review, mark up and approval of label proofs, master text production and label text localization. The solution optimises all clinical label development processes, with dedicated project management teams and supporting centralised technology (LAS), to deliver a seamless process for sponsors.
In an era of change and digitalisation, labels are one clinical supply item that often defines the critical path in the supply chain. These emerging technologies are reshaping the clinical trial landscape and with this brings a wealth of opportunities to use technology to increase R&D productivity and provide the information that sponsors need to optimise decision-making.
Almac is an experienced provider of clinical labelling, printing millions of global labels on a monthly basis. By addressing the disconnects that have become synonymous with traditional labelling processes, Almac’s enhanced Label Approval Solution offers sponsors a single secure platform for Investigational Medicinal Product (IMP) label development, management and tracking while mitigating risk through in-depth project planning. Bringing together text generation, regulatory review, translation, proof generation and proof approval within a standalone workspace enables sponsors to benefit from fully validated end-to-end label development with real-time visibility, control and traceability of label text.
Nathan Kohner, Almac Clinical Services’ Label Service Solutions Manager, commented: “We understand our customer’s challenges and we have the resources, experience and expertise to manage the range of labelling scenarios they may face. Our enhanced Label Approval Solution provides sponsors with an end-to-end review process that ensures labels meet the needs of clinical sites and patients.
By designing labels based on clinical knowledge, unique and compliant design strategies can be developed to deliver sponsor-specific solutions that suit the needs of an individual whilst mitigating risks, optimising workflow processes, saving time and money and safeguarding the patient. I am delighted to launch this solution that further cements our commitment to the advancement of human health.”