A decade ago, our founders’ experiences in clinical research and life sciences drove them to create Medable, a simple cloud-based platform that could improve theconduct of trials. Over the last ten years, we’ve conducted nearly 400 trials on our platform, continually refining it to provide a better experience for sites, patients, and caregivers.Today, we’re excited to announce that our customers are entering a new era of control, ease of use, and simplicity.

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The next level of clinical trial data capture is here. Gone are the days of paper, illegible handwriting, and data quality nightmares. eCOA, or electronic Clinical Outcome Assessments, and ePRO, or electronic Patient-Reported Outcomes, are revolutionizing the way clinical trials generate data. Both leverage digital tools to collect information electronically, offering a treasure trove of benefits. eCOA acts as the umbrella term, encompassing data from various sources like patients (ePRO), clinicians, observers, and even performance-based assessments. This holistic approach paints a more complete picture of a patient's experience. ePRO, as a subset, shines the spotlight directly on the patient's voice, capturing their symptoms, quality of life, and other critical self-reported measures.

Hear from industry leaders at this unique virtual event showcasing the eCOA/ePRO solutions of partners who are ready to help you with your clinical trial data capture needs.  Early registration is open via the form to your right.  

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.

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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.”

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. 

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Over the last decade the number of oncology trials has skyrocketed, almost doubling the number of all other therapeutic areas combined, according to the WIRB-Copernicus Group¹. Known for their complex design, oncology trials often present various participant, site, and sponsor hurdles.

Sponsors and CROs looking to tackle these challenges andreduce the burden on participants and sites should explore the potential of digital solutions, particularly electronic informed consent (eConsent) and electronic patient reported outcomes (ePRO). Both tools offer expanded views of the participant journey while offering feedback that enables sponsors and CROs to enhance and refine their trials for all stakeholders.

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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.

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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. 

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COAs (called eCOAs when captured electronically) are essential to understanding whether a drug is reducing symptoms, improving patients’ quality of life, and improving patients’ ability to perform activities they care about. COAs enable a well-rounded understanding of how a drug is working, its side effects, its impact on patients’ lives, and more. Perhaps most notably, PROs/ePROs allow for the patient’s voice to be heard. Capturing the patient’s voice is particularly important because the clinician may not always see or express the patient’s experience in the same way.

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