Knowledge Center
Quality by Design: Better data using participant insights
Quality is not an afterthought within clinical trials. Instead, it is a required and integral part of the entire process beginning at the start of protocol design. While clinical trials will always encounter challenges in driving quality experiences and data, there exists one approach that’s backed by regulatory agencies and proven to lead to better outcomes.
This is a “quality by design” strategy that’s informed and driven by all stakeholders, including those most affected by your trial’s protocols - your participants, and sites.
Latest Blogs
Experts discuss AI’s future in pharma
In June of 2022, Open AI forever changed the world’s technological landscape with the release of ChatGPT 3.5. The explosion and proliferation of AI tools have become a focal point of interest and curiosity in almost every industry, with commentators in pharma wondering how AI can improve clinical research.
In January 2024, panelists from Syneos, Obvious Ventures, Sapphire Ventures, IDEA Pharma, and GSR Ventures joined Medable’s CEO, Dr. Michelle Longmire, to discuss the purpose, potential, and power this transformative technology offers.
Here’s what they had to say.
No delays: How Medable achieves a 99% device shipment rate
With BBC Research forecasting that “the global smartphone-based patient monitoring market should reach $21.5 billion by 2027,” it’s safe to say that smartphones, tablets, and other devices have become a cornerstone of modern clinical trials.
Today’s trials use smart devices to help facilitate several important trial activities, like informed consent, data collection, patient feedback, and more. As a result, ensuring device delivery logistics has become a crucial step in getting a trial started and keeping participants engaged throughout its duration.
At Medable, we often handle device shipping for our customers' clinical trials. The team responsible for providing this service, led by Carl Franzetti, SVP of Professional Global Services has a market-leading 99% device shipment rate, with the remaining 1% resulting from normal business operation limitations such as weather outages.
The result? Our customer’s trials start on time and their participants are better engaged.
Key Insights from the FDA's DHT Guidance
On December 23, 2023, the FDA released guidance for the industry on how digital health technologies (DHTs) should be used in clinical trials.
DHTs, which the FDA defined in their “Framework for the Use of DHTs in Clinical Trials,” are “technologies such as wearable, implantable, ingestible, and environmental sensors and software applications on mobile phones, among others.”
DHTs can be used to collect data from clinical trial participants more efficiently and objectively than traditional methods. For example, DHTs can collect data on participants' activity levels, sleep patterns, and medication adherence. This data can be collected electronically, which can reduce the burden on participants and improve the accuracy of the data
White papers, Case studies & reports
Medable’s Patient Caregiver Network improves post-seizure trial data
A pharmaceutical contract research organization (CRO) expressed concerns about the timing and availability of seizure diaries for patients enrolled in their rare disease study.
They wanted to understand when patients should be prompted to complete the diaries and how they could improve the process to better accommodate caregivers' and patients' needs to produce better trial data.
Medable platform speeds diabetes study startup by 50%
A top 10 pharmaceutical company approached Medable seeking support for their Phase III diabetes study in the highly competitive weight loss market. Their primary goal was toreduce the client’s average study build timelines from 16-20 weeks, down to just 8 weeks,a reduction of more than 50%.
See how Medable was able to meet the customer's goal with this case study.
Record-breaking enrollment achieved in weight-loss study
A top 10 pharmaceutical company approached Medable seeking support for their Phase III diabetes study. Their primary goal was to reduce the participant enrollment phase timeline to get the study underway as quickly as possible.
On-Demand Webinars
Last Year’s DCT Is Today’s Clinical Trial
DCTs have transformed from a disruptive force challenging the norm to an integral concept, now widely embraced in the clinical trial landscape. Join us for this upcoming Clinical Leader Live session, where experts will explore the current landscape, highlighting the positive impact of DCTs and their transition from innovation to indispensable practice in the era of evidence generation and modern clinical trials.
Amplifying Evidence with Unified Clinical Trial Data Collection
Join us for a discussion about how combining a unified clinical trial data collection platform with intelligent automation can revolutionize drug development and why the current status quo is no longer sufficient. With novel capabilities, the industry can now explore new possibilities, such as incorporating additional sensors to identify surrogate or alternative endpoints, rethinking adaptive trial designs, and quickly responding to emerging data.
Keeping up with ClinOps: Why and how to improve delivery
Medable is joined by Join GSK and Lightship for a panel discussion on how a trial platform as a service can enhance, expedite, and improve the day-to-day operations of clinical operations across the life cycle of a study.
Scientific 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
Development of a mobile health app (TOGETHERCare) to reduce cancer care partner burden: Product design study
Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.
Guides
How AI and ML can transform clinical trial conduct
There’s little doubt that 2023 will be remembered as the breakout year for generative artificial intelligence (AI) and machine learning (ML) within both tech and pharma. Much like the surge in digital and decentralized trials in 2020, AI and ML have sparked a paradigm shift in what is possible in the development of drugs and treatments.
With the FDA’s recent publications providing a future framework, sponsors and CROs everywhere are researching how best to bolster drug development. With all these advancements happening at an unprecedented pace, we’re providing an overview of the uses of AI and ML in clinical conduct below.
Back to basics: What are wearables and how are they powering diversity and efficiency
Mobile health technology, like medical-grade wearabledevices, can transform patient monitoring by enabling the collection of newtypes of data and better accuracy of patient responses. This tech can increaseaccessibility of trials for patients and even increase diversity and reducepatient burden by removing geographical and travel barriers.
As a result of these myriad benefits, we’ve seen theincreasing inclusion and acceptance of wearable devices throughout clinicaltrials. Here, we’ll dive into the specifics of these helpful tools and theirimpact on the future of medicine.
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.