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.

There’s no doubt that study launches come with extremely high stakes for sponsors requiring precise coordination over numerous critical activities across multiple stakeholders, including regulatory bodies, ethics committees, investigator sites, and internal teams. Now, sponsors can see exactly what’s happening live across assessments, instruments, translations, and more. This is true whether their internal teams handle launch activities or whether vendors handle them, a stark contrast to the traditional technology development process.

The landscape of clinical trials is undergoing a significant transformation as digital measures and digital health technologies (DHTs) continue to evolve and prove their worth. 

As of December 2023, approximately 1,550 clinical trials worldwide utilized wearable devices, representing about 2% of all trials. While this percentage may seem small, it marks a steady increase since 2014, and the momentum is set to accelerate.

A top-10 American pharmaceutical company came to Medable looking to conduct an extensive weight management master protocol clinical trial with multiple sub-studies across 70+ research sites. The client was concerned about the participant experience, as the trial required participants to enroll through the master protocol before enrolling into a sub-study. Additionally, they wanted to reuse and scale the solution for future trials without compromising the site and patient experience.

Learn how Medable was able to accomplish this and more.

The pharmaceutical industry faces a daunting challenge: it takes an average of 12 years and $3 billion to bring a new drug to patients, with the FDA approving an average of 50 new therapies yearly. 

This pace is inadequate to address humanity's needs and our own future goal of helping the industry produce ten times the number of treatments it does today. 

A significant bottleneck is the lengthy clinical trial process, where Phase 3 studies alone can span three years or more. However, a critical factor compounding these timelines is the difficulty in recruiting sufficient patients for these crucial studies, often adding up to 2 years to the already protracted journey. 

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.

With the share of oncology trials continuing to increase, the case for using digital tools in these trials grows with it.

Today, cancer trials are the most commonly researched of all diseases, with their share of clinical trials growing each year. According to research from Tufts CSDD,  the number of cancer drugs “has nearly quadrupled since 2000, to 1,489 trials in 2021, up from 421 two decades earlier.”

Tufts CSDD notes that this growth comes as “oncology drug developers are increasingly shifting toward precision medicine, embracing new molecular targets and improvements in genetic sequencing technologies”

A leading biotech company came to Medable looking to conduct a vaccine trial. They were concerned that their trial’s participant population of persons aged 50+ years may be hesitant to use the sponsors’ chosen eCOAtrial technology, would not be engaged in the study, and therefore may not provide consistent trial data.

Learn how we drove success for them, including 90% eCOA adherence.

Modern clinical trials employ various digital-based tools and technologies designed to increase the speed, accuracy, and ease of conducting clinical trials. In the best-case scenario, these tools are housed in the same experience or a  “clinical trial platform.” 

Clinical trial platforms are software-based, web-based, and/or cloud-based solutions that facilitate clinical trial research throughout its entire lifecycle. They offer a complete technology ecosystem that connects patients, research sites, and trial sponsors from patient recruitment to close out and data submission. Users of clinical trial platforms can access and operationalize all of their digital-based tools through this connected platform. Platforms can prevent users from accessing parts of the platform not permitted for them. For instance, participants can not view other participants' data or gain access to tools meant for sites. Other users, like sponsors’ study teams, have access to the full suite of tools as needed based on their roles.

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.

‍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. 

As we look ahead to 2024, the landscape of clinical development is poised for significant advancements in digital and artificial intelligence. As leaders in clinical outcome measurement and innovation, our team at Medable is mission driven to continue to accelerate clinical development timelines with transformation technology.