Avoid High Risk, Non-Compliant Clinical Labeling Content
Pharmaceutical companies that conduct global clinical trials are required to produce booklet labels that comply with local regulatory requirements by country. A booklet label is a little booklet that is attached to the drug that is being distributed for a clinical trial. A single booklet label must be produced in multiple languages, representing the countries that are participating in the clinical trial.
Each country will have a set of rules defined regarding what information must appear in the label. A label for a single country contains short phrases that define certain aspects of the drug such as drug strength, drug form, safety information, storage conditions, dosing instructions, and others. It is critical that the correct information be placed on the correct label to ensure patient safety and compliance with regulatory agencies.
Most companies currently employ a manual process for the creation and management of clinical trial labels. These booklet labels are created from scratch each time and translated into the necessary languages. Manual checks must be performed to ensure that the correct phrases are included for the drug and that regulatory requirements are met. This manual process has the potential for error which could result in product recalls costing millions of dollars.
Glemser’s Clinical Label Development System (xmCLDS) reduces the potential for human error and label creation time by assisting users with the creation and management of booklet labels. The system utilizes a library of approved phrases and a business rules engine to predefine a set of phrases required for a label based on information such as country, label type and package type, as well as a set of predefined questions. Authors can add optional phrases to the label as needed after creation. The label is initially created in English. Once approved the booklet label is generated into all required languages based on the phrase translations stored within the system.
Authorized users can manage the phrase library and business rules as needed to accommodate changing regulatory requirements and business processes. Change control is built into xmCLDS and will ensure that processes are followed before making any changes to approved content.