Blog posts
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.
Bridging the gap: Ensuring sites are successful with Medable
For years, clinical research sites have been vocal about the technological challenges they face conducting trials. Obstacles such as multiple disparate systems per trial, an abundance of passwords, lack of interoperability, and other issues all showcase how technology can be as significant a hindrance as it is a boon. As a recent Forbes article suggests, if clinical research technology doesn’t empower sites, it risks slowing down the entire trial.
Connecting in new ways: Our partnership with Withings Health Solutions
In June, Medable announced a partnership with Withings Health Solutions with the goal of reducing the burden on sponsors and sites while empowering patients to participate in trials from home.
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.
New EU Regulatory Recommendations for Decentralized Trials Keep Focus on Patients and Sites
As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.
Patient perspectives: A year of pharma webinars showcase what’s working and what needs work
Learn what industry topics, trends, and focuses are being well received by patients and caregivers with this blog.
J.P. Morgan Week 2023: Trends, highlights, and themes from this year’s conference
See what key trends and takeaways were at the 2023 JPM conference and how they'll drive the landscape of pharma.
How we standardized deploying vaccine studies in five weeks
By Musaddiq Khan, VP, DCT Solutions
At Medable, we’re always looking to understand the changing environment of clinical research, and how we can help customers overcome the various challenges, risks, and scenarios that these changes bring.
For the past year, I, various clinicians, and research experts at Medable have been working closely to improve how we conduct research for various therapeutic areas. Much like the results shown in Tufts CSDD’s latest whitepaper, we believe that a well-thought, decentralized approach can help bring new therapies in historically challenging therapeutic areas to markets faster.
The result of this work is a brand-new decentralized approach we’re bringing to the market.
2023: The year of the site. We are listening.
As 2022 rounds the bend, the life science industry is at a critical juncture in the adoption of the decentralized clinical trial (DCT) model.
Five myths about eConsent
As our industry continues to follow new paths to digitization, it’s important to debunk the most prevalent myths — both old and new — and reach a deeper understanding of decentralized clinical trials.
DCT takes center stage at DIA 2022 with new Tufts CSDD Study
DIA 2022 provided four days worth of content spanning over 13 talk tracks and hundreds of speakers with three major takeaways.