Digitizing clinical trial operations
eLabels for a patient-centric supply chain
With the advent of mobile devices such as smartphones or wearables, eLabeling is the alternative to booklet labels and has a great potential to gain a competitive advantage to any organization to achieve a fully digital clinical trial process. At Tenthpin, we have the industry insights and technological know-how to make the digital transformation happen with you.
What is eLabeling?
An eLabel is the provision of a full label on an electronic device, being linked to some type of physical label on the product. The concept of eLabeling involves leveraging technology to improve the labeling process and adapting to digital transformation in the clinical trial operations. With organizations and governments worldwide seeking for ways to progress towards a digitally supported patient-centric supply chain, an eLabel solution is a catalyst for clinical supply labeling transformation.
Why to transition from physical to electronic labels
Printed labels and booklets are still the norms for Investigational Medicinal Products (IMP); however, it does not come as a surprise that companies are looking into options to go paperless. Electronic labels, or eLabels, have become buzzwords in the life sciences industry, as current paper based labeling processes cause pain points for all stakeholders.
Patients: Booklet labels tend to be of low usefulness. Few are opened and there is limited space which is why they may find small fonts and no helpful administration information.
Sites: They struggle with space constraint on the labels where they must write information to meet regulatory requirements. Other than trial alias and kit number, there is no other utility to the sites.
Sponsors: Having to manage paper labels, especially in global trials, usually means a lengthy creation and approval process, which causes delays in getting medicines to the patients.
Benefits of eLabel solutions across the industry
Benefits for patients
- Receive medicines faster due to increased efficiency in clinical development process
- Improved usability through use of electronic reading devices
- Dosing videos make it easier to comply
Benefits for sponsors
- Increase operational efficiencies in label creation
- Decrease waste and decrease reaction time to study changes
- Increase options for value adds such as patient analytics, patient education, adherence programs
Benefits for health authorities
- Ensures most up-to-date information is available to patients
- Ties into broader digital innovation strategies
- Decreases potential for deviations during extension re-stickering: e.g.: sterility, tamper evident seal
Benefits for sites
- Rapid access to up-to-date information
- Foundation for improved patient engagement
- Supports education of patients and improves efficiency in labeling approaches
Making you a leader in the eLabeling space
Getting the architecture right is key. At Tenthpin, we are in the unique position to build a strong tech ecosystem and help you become a leader in the elabeling space. Our consultants are tech-savvy with a deep understanding of the intricacies of the life sciences industry, and more specifically the clinical supply world.
Mobile access to label content
Managing and displaying label content
By combining SAP GLM and SAPs strong cloud and mobile capabilities we created an integrated solution for eLabels. It includes approval of label content, label proofs, and label generations.
How our solution supports digitization of labeling
Leveraged by the broader pharma industry, it facilitates uptake and consistency.
Being adaptable to core ERP functionality, it supports content creation.
Providing dynamic labels and alerts, it allows for patient-centric features and additional site enhancements.
Decreased reliance on booklet labels and acceptance of country agnostic labels, leads to additional cost savings.
How other applications can build on electronic labeling
Integrated eLabel
Site and patient information available upon randomization and enrolment. Automated push of information from system to patient. Links to patient safety information.
e-Patient communication
Establishes digital communication with patient such as text messages, email, e-diary, treatment reminders, how-to videos, etc.
IMP tracking
Automatic verification and registration of all kit handlings at site: e.g., receipt, hand out to subjects, return of subjects, shipment for destruction.
e-Adherence
Automatic registration till lowest level count (drug accountability). Smart packs to monitor if the right medicine is taken at the right time.
Did you know that eLabeling supports you in meeting regulatory requirements?
Regulatory requirements differ from country to country. In the US and Japan, for example, the expiry date is not always required on the label, making any retest date extensions easier to manage.
Labeling is one of those fascinating clinical trials topics that our consultants have been involved in for over ten years.
Contact us to receive expert advice.
USA
Mahesh Kumar
Partner
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