Total Consent
Evolving Total Consent: Introducing digitally-enabled biosample consent storage
Within biosample storage, a “nightmare scenario” exists that Medable and our clients discuss regularly.
Some years ago, a sponsor with tens of thousands of biosample specimens identified that they had lost the ability to link their biobank samples' documented consent for storage (and further research). The consent for these samples was taken on paper, but a system to collate and file the consent data attributed to each specimen was not implemented. When the organization couldn’t find the paper consent, they were forced to dispose of thousands of biospecimens, losing the ability to conduct valuable research and potentially millions of dollars of lost IP.
How partnership ensured a successful first digital trial
Since our inception in 2015, Medable has conducted over 300+ digital and decentralized trials using eCOA, eConsent, telehealth, and more. However, just as a bell curve shows, adoption rates for new technologies can wildly vary across our industry. While some organizations quickly implement new technologies, others take a more cautious approach.
Together, this team, which included Mihai Viisan, a Solution Design SME, Luka Ajduk, a Product Implementation Lead, and Ted Meyer, the Supply Chain Coordinator, built a trusting working relationship in which Medable led study implementation.
U.S. Renal Care achieves 75% site adoption of eConsent with Medable
Medable’s Total Consent, used by U.S. Renal Care in top ten pharma-sponsored study, proved to be a flexible, fast, and efficient solution for the elderly renal care population.
Bringing empathy into the digital environment
Learn best practices to incorporate empathy and human interaction in the digital environment with attentive listening, building relationships with sites, promoting clinical trial technology implementation, and learning from other industries that have successfully transitioned to digital.
You asked, we answered: How long to plan for your first eConsent implementation
Implementing digital informed consent (or eConsent) in clinical trials can be challenging and complex, but it doesn’t have to be! One of the main reasons for this difficulty is the traditional mindset and habits of conducting clinical trials. Clinical trials have long relied on paper-based informed consent process, and making the switch to a digital solution requires a significant shift in mindset and approach. Additionally, different stakeholders, such as study sponsors, ethics committees, regulators, sites and patients, may have different expectations, perceptions and requirements for eConsent implementation, adding to the complexity of the process. Therefore, careful planning, communication, and a thoughtful execution are essential for the success of an eConsent implementation and adoption in studies.
What it really takes to adopt eConsent across large pharma
Learn about the benefits of adopting consent management technology and best practices around developing change management and training programs to help sponsors, CROs and sites get the most out of eConsent.
The importance of quality in the informed consent process
Join Aditum Bio's Shayanne Ali and Medable's Andrew Mackinnon, as they discuss the most common issues with the paper-based consent process, and what to look for in a complete consent management solution in order to reduce quality issues while improving oversight.
White paper: Why eConsent primes patients and studies for success
Read this white paper to learn how eConsent's flexibility helps you educate and retain patients worldwide, regardless of signature requirements, and how to implement it across your organization.
White paper: The foundations of decentralized clinical trials
Understand the benefits of web-enabled research tools and how they work.