Almac Clinical Services, the clinical supply arm of contract development and manufacturing organization (CDMO), Almac Group, announced the launch of its enhanced Label Approval Solution (LAS).
LAS is designed to provide drug developers with an end-to-end solution to more effectively manage their clinical labels, from initiating the protocol procedures until final printing.
A spokesperson from the company explained to us that the service will be enhanced compared to the existing offering in terms of accuracy, visibility and traceability.
More specifically, it will offer the ability to manage and monitor the label approval process, providing increased control, as well as facilitated access through the cloud-based system ensuring that master text, final label text and proof approval are completed online.
Moreover, label revisions will be fully attributable and immediately visible to all parties, with the audit trail directly embedded in the files for in line review with the file itself.
The company also plans to offer its clients an improved dedicated team to oversee the entire label development process, with a 24/7 helpline for support.
Additional features that the online software platform supports include text generation, regulatory review, translation, proof generation and approval, concurrently with real-time visibility, control and traceability of label text.
Labels are a clinical supply item that often “defines the critical path in the supply chain,” stated the company, adding that the integration of digital technologies are reshaping the clinical trial landscape, bringing a ‘wealth of opportunities’ to the industry.
Unlike traditional processes, the digital labeling platform is expected to allow label development, management and tracking while mitigating risk through in-depth project planning.
The medium to patient interaction
When asked about the importance of fast and quality labeling in clinical research, the spokesperson told us that labeling is a key component of the drug product, and one of the main ways in which patients interact with a clinical trial.
“Accurate labeling is critical for patient safety, regulatory compliance and, ultimately, success of the trial. Often errors in many trial documents may be resolved through amendments submitted to the regulator,” explained the spokesperson.
They added that, however, certain errors in label text can result in recall of the drug and immediate risk to patients, and therefore accuracy in label text for clinical supplies is ‘imperative’.
Moreover, the spokesperson explained how there have been many developments recently in drug product identification utilizing centralized information or machine-readable data. However, “human readable text still has a key role in clinical label text in today’s world,” the spokesperson concluded.