eConsent
Building a “gold standard” clinical trial experience in Japan
When talking to customers conducting their first multi-country trial, we sometimes liken clinical trials to spider webs. Just as a garden spider’s web differs from a black widow’s, clinical trials follow unique patterns in every region. Each country comes with its own set of rules, ethical standards, approval processes, and data privacy laws. Cultural factors also play a crucial role in how patients are recruited and understand Clinical trials, requiring sensitive communication and a deep respect for participants’ needs.
In Japan, these regulatory and cultural intricacies form a complex ‘web,’ with anchor points and structural requirements that, when understood and implemented correctly, create a framework for success. However, conducting Clinical trials in Japan has historically posed challenges for Sponsors and Contract Research Organizations (CROs). When we first entered the region, one Sponsor consistently cited issues with eCOA solutions and site and patient support, not fully adapting to Japan’s unique requirements. This feedback, combined with our own experiences on the ground, revealed a clear need for improvement.
Today, we can proudly say that the solutions we put in place have transformed Japan’s Clinical trial landscape, and what was once a challenge has now become the “gold standard” for supporting Clinical trials in the region.
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
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.
ePROs: Transforming oncology research
In this webinar, VP of Digital Trial Solutions Musaddiq Khan, VP of Product Strategy Colin Weller, and Cancer Survivor Lindsey Matt discuss how Medable is supporting a patient-first approach in complex Oncology clinical trials
Digital vs digitized: Common myths about eConsent for clinical trials
Alex Burrington, CTI Principal of Vertex, and Andrew Mckinnon, VP, GM of eConsent discuss common myths around eConsent, how to improve comprehension with patient-centric consent, and how to use a digital consent management tool to improve trial compliance, quality, and 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.
Using clear language and the latest technology in informed consent forms (ICFs) for clinical trials
Explore ways to improve the consenting communication process using clear language and the latest technology.
White paper: The foundations of decentralized clinical trials
Understand the benefits of web-enabled research tools and how they work.
Improve trial enrollment using patient perspectives and technology
In this webinar, Nisha Trivedi, Patient Advocate, and Jena Daniels, VP of Patient Success showcase how adding technology in clinical trials enables greater diversity and an increase in study enrollment upfront and maintains patient engagement over the course of the study.
Webinar Highlights:
- Establishing internal relationships with end-users (patients, caregivers, and sites) will increase technology adoption
- Using technology to increase participant access, engagement, retention, and education
- Navigating uncertainties in technology and approach while balancing the needs of participants providing them with a positive and differentiated experience
- Ensuring patients, caregivers, and sites are engaged in the study design and implementation process
White paper: The building blocks of DCT. How to create a seamless experience across eConsent, eCOA and more
Combining multiple market solutions at the site level can result in a negative experience due to different processes, login credentials, and redundant training. A unified DCT platform that works seamlessly with other core clinical systems to streamline workflows and simplify key trial processes.
Where does patient recruitment end and patient engagement begin?
It’s widely understood that patient recruitment is one of the most critical and yet most challenging aspects to a successful clinical trial. In fact, many trials fail to reach recruitment goals, with far-ranging implications for investigators, sponsors, study participants, and the population affected by the disease or condition under study.
