An electronic label, or eLabel, is the provision of a complete investigational medicinal product (IMP) label on an electronic device while still utilizing some type of single panel label on the physical packaging. A simplified physical label would contain minimal information in a single language and/or symbols that are language neutral for identification and traceability purposes.
Currently the booklet labels used on IMP are static, require long lead times to develop, are costly and may not include helpful information for the patient. They offer little utility for the sites and merely fulfill regulatory requirements. The directions are commonly written as “use as directed” so no specific administration directions are included. The letters can be as small as 4 pt. font, which makes the labels difficult to read. Overall, the current booklet process increases timelines and cost for development, which drives up the cost of developing new medicines and may delay patients from receiving their clinical trial material.
The TransCelerate eLabels initiative will help the industry progress on the journey to digitally supported, patient-centric clinical supply chains. The main output is not an eLabeling system, specifications or a standard, but an implementation toolkit to facilitate voluntary, modular adoption of eLabeling and to assist in Health Authority engagement.
Benefits for Patients
- Increases efficiency in clinical development allowing for patients to receive medicines faster
- Increases patient safety
- Enhanced utility of clinical labels and potential for better compliance, e.g.:
- Dosing videos
- Supplements to communication
- Improved usability (e.g. larger font size)
Benefits for Sites
- Rapid access to up-to-date information
- Greater efficiencies in Labeling approaches
- Lays a future foundation for engaging with the patient about their medication
Benefits for Regulators
- Decreases potential for deviations during extension re-stickering: e.g.: sterility, tamper evident seal, product mix-up, time out of environment
- Ensures latest information available for patients
- Ties into broader digital and innovation strategies
Benefits for Sponsors
- Increases operational efficiencies in creation of label
- Allows for additional pooling strategies which decreases waste
- Decreases reaction time to study changes
- Increases options for significant value-adds such as adherence programs, patient analytics, patient education
The eLabels Initiative has developed an implementation toolkit to facilitate voluntary, modular adoption of eLabels and to assist with Health Authority engagement. Read on to explore our eLabels Initiative Assets.
The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to increase insight into patients’ understanding, increase regulatory compliance, and reduce quality risks.
The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.