Blog posts
How partnership ensured a successful first digital trial
For the last twenty years, clinical trials have been steadily digitizing.
As the EDC and eTMF systems of the early 2000s gave way to the eCOA and eConsent tools of the 2010s, site, and participant experiences throughout clinical research were improved.
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.
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
Trends, insights, and news from SCOPE 2024
With over 3,300 attendees across 850 companies, the 16th annual Summit for Clinical Operations Executives (SCOPE) was a huge success. As previous years have shown, what’s big at SCOPE tends to be big for our industry. Thus, we’re summarizing some key takeaways from this year’s conference to understand where the industry may be headed next.
Defining “evidence generation” within modern clinical trials
Medable has always been, at its core, a platform that enables clinical trial sponsors to collect data and generate evidence to answer scientific questions.
But from the start, Medable has done things differently. Today, the flexibility, purpose, and build of Medable’s evidence-collection platform is what sets us apart from others in our space.
Taking eCOA technology deployment off the critical path
Within the context of clinical trials, the "critical path" refers to the sequence of activities, tasks, or events that, if delayed or extended, would directly impact the overall timeline for the trial.
These essential steps and dependencies must be completed in a specific order to ensure the trial stays on schedule. Any delay in the critical path can potentially lead to a delay in the entire trial, affecting its completion date and potentially increasing costs. Identifying and managing the critical path is crucial for efficient trial management and timely delivery of treatments to patients.
For a simpler example, take a look at how Monday.com describes the critical path within the context of building a house and their visual aid in Exhibit 2. “For example, if you’re building a house, the critical path might include digging the foundations, building the walls, and installing the roof. If any of these critical activities fall behind schedule the whole project gets delayed.”
J.P.M. Week 2024
Over 8,000 participants from all corners of the globe descended on San Francisco this week to attend J.P. Morgan's 42nd Healthcare Conference, taking place at the Westin St. Francis hotel,.
With JPM known for its ability to offer previews of the year ahead, we took the time to summarize the news, trends, and highlights that made waves during this year’s conference.
You asked we answered: How do eCOAs improve data compliance?
We at Medable are often asked in webinars, requests for proposals (RFPs), tradeshows, etc. just how exactly eCOAs and ePROs foster better patient compliance with submitting data.
Since you asked, our answer is below, courtesy of Jessica Dolfi, VP of Solution Consulting.
Rapid evolution: How DCT’s DNA became standard in modern clinical trials
It’s impossible to deny how different clinical trials look almost four years after the pandemic revolutionized clinical research. Today, the digital and decentralized tools and technologies that enabled clinical trials to carry on through the COVID-19 pandemic are present (in some form) in nearly all clinical trials, a far cry from the dynamics of 2019.
Unlocking scalability in pharma with AI
What is the path to addressing the remaining 10,000 human diseases?
Almost two years ago, Medable CEO Michelle Longmire asked this question in a blog titled “Accelerating the path from possibility to proof in the development of new medicines.” Back then, she wrote that leveraging the most meaningful tools we had at the time would drive new synergies at the intersection of safety, science, and speed and enable a new era of drug development.
Today, our industry stands at the precipice of a new era in clinical research, marked by rapid advancements in technologies that society widely refers to as artificial intelligence and machine learning (AI and ML). While each of these technologies has existed for some time, recent advancements in their capabilities have brought them to the forefront of our industry.
In the future, AI and ML may prove to be the most important technologies of our time, as they have the potential to enable true scalability in pharma, as well as other business sectors.
Patient perspectives: The balancing act of trial participation
When we think about clinical trials, our minds often gravitate toward the scientific intricacies of these studies - the testing of new treatments, data analysis, and the quest for medical breakthroughs. However, it's essential to remember that behind every clinical trial, there's a patient, and often a caregiver, whose life is deeply impacted by this journey.
So, let’s consider this: the concept of "Participation-Life Balance" and how technology can enhance the design and workflow of clinical trials while acknowledging the holistic needs of patients and caregivers to work towards achieving this.