When TransCelerate announced in 2015 that it would be launching an e-labeling initiative, the news was met with audible sighs of relief across the pharmaceutical industry. The case for e-labeling has been made on many occasions and it seemed not so long ago like it might never come to fruition, leaving trial drugs stuck with their current bulky and static paper booklet. At the best of times, the necessity for re-prints when changes are made to the clinical trial can prove costly and time consuming. This is especially the case when you consider the small likelihood the booklets are actually read by patients. With the e-label initiative, there will be a shift towards greater benefits for both patients and trial sponsors and from here the opportunity to further expand the electronic medicines platform.
In recent years there has been a clear shift by trial organizers and clinicians to create more patient-centric clinical supply chains, ensuring patients’ needs and requirements are put at the center of each trial protocol. The digitalization of the clinical supply chain and specifically the labeling and safety information can make the trial more accessible to patients, giving them greater insight and autonomy over their personal care. By improving the readability of labels in clinical trials, as well as providing patients with accompanying messages, there is the potential for greater compliance. Furthermore, it is expected to minimize clinical labeling timelines and make huge cost-efficiency savings.
The introduction of elabeling will open a door wide with possibilities to build upon these initial benefits and spread out across the clinical supply chain to make accessible trials the norm. TransCelerate is therefore beginning this journey through the development of a model playbook that will aid the company’s realization of elabeling, a Collaborative Health Authority engagement plan and materials, and clinical labeling productivity tools. Using this information, gathered in collaboration with regulatory agencies, there will be clear guidance on establishing compliant and effective elabeling suitable for the intricacies of your trial protocol and patients needs. There is in future the potential for tailoring the labels based on analytics and insights gained through the technology to gain a greater understanding of how patients interact with the e-label and ensure their needs are met through the delivery.
In line with the long awaited move to digital, TransCelerate are also working on such initiatives as eConsent, which will tie into the patient-centric goals of the e-labeling initiative. Through eConsent the patient will gain a greater understanding of the trial they are signing up to and this initiative is also expected to raise regulatory compliance and minimize quality risks.
To find out more on the update of what TransCelerate are doing and the progress which has been made then join them on July 20th at Outsourcing in Clinical Trials Midwest in Chicago, Illinois. Here, the TransCelerate lead for elabeling, Jodi Smith-Gick, will be delivering a session informing on what work has been done towards elabeling so far and what advances are still to be made. To book your place at the event click here.
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