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Blog posts

Building a “gold standard” clinical trial experience in Japan

Japan
6 min

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.

Blog posts

Tips for better eCOA experiences from our Patient Caregiver Network

eCOA
6 min

Electronic Clinical Outcome Assessments (eCOA) have revolutionized data collection in clinical trials, offering convenience and real-time insights that traditional methods cannot match. 

However, the effectiveness of these digital tools hinges on the quality of the daily experience they offer participants. Read below to see direct feedback from patients and caregivers across multiple conditions in our Patient Champion Network (PCN), as we identify ten critical factors that can improve the eCOA experience.

Blog posts

DTRA 2024: GSK and Medable discuss change management and DCTs

On Friday, November 15, 2024, the Decentralized Trials & Research Alliance (DTRA) held a fireside chat between Brandon Maggio, GSK’s Global Head of Digital Operations & Process Optimization, and Alison Holland, Medable’s Chief Customer Officer. They were gathered to discuss the evolving landscape of decentralized and digital clinical trials and how best to drive change management in an era of continual changes within trial research. The following blog is a summary of their discussion.

White papers, Case studies & reports

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White Papers, Case Studies, Reports

Case study: Medable beats forecasted FPI date while raising eCOA adherence in Japan

eCOA
6 min

A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan.

Recognizing Japan’s distinct regulatory, cultural, and logistical landscape, the company partnered with Medable todevelop an initiative to enhance the region’s patient and site experience.

White Papers, Case Studies, Reports

Use Case: Integrating consent data to reduce administrative burden

A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves.  The sponsor sought to find a vendor that could use one eConsent system to manage paper and electronic consent.  Additionally, they sought to use the central eConsent system to populate the clinical trial sites’ IRB and EDC systems,  as well as some internal systems.

Participant in a diabetic polyneuropathy trial
White Papers, Case Studies, Reports

Use case: How a top-10 pharma digitized and standardized participant pain body maps

A top-10 pharmaceutical company was looking to standardize the conduct of their diabetic polyneuropathy trials for future use.

Specifically, the client was looking to digitize their paper “body map” forms. These are used by participants to indicate the severity of pain on their bodies. 

Traditionally administered on paper, body map assessments had been a source of potential inefficiencies and errors. 

The client’s goal was to co-create and own their body maps, while simplifying and streamlining the process for future trials.

On-Demand Webinars

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Webinars

Defining the right digital strategy for oncology: What do you want to measure?

Join us to find out how to optimise oncology clinical trials using digital tools to accelerate decision-making.

Clinical trial digital future is now webinar
Webinars

The New Era of Evidence Generation in Clinical Trials   

In this webinar, learn how top pharma are using novel innovations to drive greater speed, scale, and access in clinical research than ever before in this webinar hosted by Musaddiq Khan, Vice President of DCT Solutions at Medable. 

webinar patients as partners clinical trial
Webinars

Optimizing Digital Evidence Generation Using the Patient’s Lens

Uncover how Medable drives success by leveraging patient-centric insights and eCOA technology to enhance data quality/compliance, diversity, and retention in clinical trials.

Scientific Research

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Research

Assessing the financial value of decentralized clinical trials

Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted

Research

Development of a mobile health app (TOGETHERCare) to reduce cancer care partner burden: Product design study

eCOA
6 min

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

Guides

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Guides

How to improve eCOA data quality in clinical trials

eCOA
6 min

Electronic clinical outcome assessments (eCOA) have become essential for modern clinical trials, offering numerous advantages over traditional paper-based methods. However, the benefits of eCOA can only be fully realized if the data collected is of the highest quality. Ensuring data quality in eCOA clinical trials requires a multifaceted approach, encompassing platform design, patient engagement strategies, robust data validation procedures, and strict adherence to regulatory guidelines. This blog post explores key strategies for achieving and maintaining data quality throughout the eCOA process.

Guides

The role of eCOAs and wearables in modern oncology clinical trials

In the rapidly evolving landscape of oncology clinical trials, the integration of electronic Clinical Outcome Assessments (eCOA) and wearable technologies is revolutionizing how data is collected and patient experiences are monitored. These technologies offer unprecedented opportunities to enhance data quality, improve patient engagement, and enable real-time tracking of treatment efficacy and side effects. This blog post delves into the pivotal roles that eCOA and wearables play in modern oncology clinical trials, highlighting their impact on patient-centric research and the advancement of cancer care.

Guides

Top technical considerations with eCOA in clinical trials

eCOA
6 min

Explore the prevalent challenges encountered in eCOA clinical trials, from technical issues and patient adherence to data security and regulatory adherence, and discover strategies for mitigation.

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