Clinical Trial Supply Labeling
Clinical trial supply labeling has seen a shift in recent years due to COVID-19, decentralization, growth of biologics, and adaptive trials. Pharma sponsors and their outsourcing partners in clinical supplies, need solutions to help manage increasingly diverse production and regulatory pressures.
The proven solution for clinical trial supplies labeling
Enable regulatory compliance
Simplify label reviews and approvals. Information that accompanies clinical trials is essential in ensuring the safe and effective use. A streamlined solution can help you manage and design label content, inserts and packaging with ease.
Improve response times
Enable new supply chain models. The cost of stock overage and the risk of labels with out-of-date expiration and dosage information is significant. Dynamic label generation offers efficiency, speed, and agility to enable Just In Time (JIT) printing and packaging models.
Simplify label and booklet design
Move beyond manual processes. Each country has their own regulatory and language requirements, however, you can automate processes to reduce clinical label and booklet design and printing from weeks to hours, while ensuring regulatory requirements are met and removing errors.
Drive continuous improvement
Integrate with critical systems. Automate and simplify real-time vision print inspection of content and design for every printed label to minimize operational inefficiencies and identify errors at time of print to reduce associated risks.
Centralize control for traceability
Visibility offers true benefits. Maintain complete integrity of your label data to meet compliance with FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820. Enabling a view of master data assets provides the ability to control, optimize and help ensure compliance.
Support global requirements
Avoid risk of error. As the number of countries included in each study increases, so does the need to meet specific regulatory content, phrase, and language requirements. Having an automated solution helps to reduce timescales and prevent errors.
Related resources
Case Study
Loftware onboards new cloud-based labeling platform within weeks for clinical trial supplies specialist RxSource
Discover how Loftware helped RxSource support the ethical procurement and delivery of medicines globally, focusing in Clinical Trials, Research & Development and Expanded Access Programs.
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The management of labeling for clinical trials has always been a complex subject, especially when considering the global nature of most research.
Press Release
Loftware Unveils New SAP Labeling Integrations for Accuracy, Compliance, and Cost Savings
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