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Blog posts
Six steps to help you choose the right clinical trial partner
“This year, we’ve decided to stick to paper. We know what we’re getting and we’ve always done it this way.”
That was the unwavering response from a clinical operations lead at a pioneering biotech when asked why they still relied on paper diaries for patient-reported outcomes.
Despite the growing complexity of global trials, the promise of real-time data, and the surge of digital capabilities available today, some organizations have held tight to a method of clinical trial conduct that’s increasingly as outclassed as it is outdated.
It’s well known that individuals and organizations believe that change can be daunting, stressful, and difficult, especially when the old way is familiar and entrenched. However, much like anything else, having a partner who can help guide you through the process is massively important. But, how do you find the right partner for your trials?
Before locking in a vendor, organizations must engage in a deliberate process to assess their needs, align stakeholders, and set the foundation for long-term success. This blog explores the critical steps sponsors should take before selecting a digital partner, using insights and frameworks drawn from Medable’s therapeutic area standards and industry best practices.
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.
New EU Regulatory Recommendations for Decentralized Trials Keep Focus on Patients and Sites
As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.
Patient perspectives: A year of pharma webinars showcase what’s working and what needs work
Learn what industry topics, trends, and focuses are being well received by patients and caregivers with this blog.
J.P. Morgan Week 2023: Trends, highlights, and themes from this year’s conference
See what key trends and takeaways were at the 2023 JPM conference and how they'll drive the landscape of pharma.
How we standardized deploying vaccine studies in five weeks
By Musaddiq Khan, VP, DCT Solutions
At Medable, we’re always looking to understand the changing environment of clinical research, and how we can help customers overcome the various challenges, risks, and scenarios that these changes bring.
For the past year, I, various clinicians, and research experts at Medable have been working closely to improve how we conduct research for various therapeutic areas. Much like the results shown in Tufts CSDD’s latest whitepaper, we believe that a well-thought, decentralized approach can help bring new therapies in historically challenging therapeutic areas to markets faster.
The result of this work is a brand-new decentralized approach we’re bringing to the market.
2023: The year of the site. We are listening.
As 2022 rounds the bend, the life science industry is at a critical juncture in the adoption of the decentralized clinical trial (DCT) model.
Five myths about eConsent
As our industry continues to follow new paths to digitization, it’s important to debunk the most prevalent myths — both old and new — and reach a deeper understanding of decentralized clinical trials.
DCT takes center stage at DIA 2022 with new Tufts CSDD Study
DIA 2022 provided four days worth of content spanning over 13 talk tracks and hundreds of speakers with three major takeaways.
Using clear language and the latest technology in informed consent forms (ICFs) for clinical trials
Explore ways to improve the consenting communication process using clear language and the latest technology.
How to bring patients into the product journey
Technology today has given patients unparalleled access to information and influence over their health care. As a result, many clinical trial sponsors now recognize the importance of taking a “patient centric” approach to clinical trials. That means designing a treatment, clinical trial, or other health solution centered around the patient, and includes getting feedback from patients, caregivers, families, and advocacy groups every step of the way.
In other words, it means treating patients as informed stakeholders whose participation is key to a successful trial and product following marketing authorization. Engaging patients and truly bringing them into the product journey has the power to transform the future of research and medicine. Read on to understand what patients expect from clinical trials today, and how to engage them throughout the product journey.
Meet patients where they are with consent information
The cornerstone of access to any clinical research project is the informed consent process–the decision of a participant to join a study based upon full and complete sharing of information about what the study will require, the risks of participation, and the voluntary nature of that participation.
This isn’t simply the participant’s signature on a paper or electronic form. According to governmental organizations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), that signature is only part of the process. Of perhaps even greater importance is the provision of information to the patient accompanied by a discussion of the study and a chance to have questions answered, so that the decision can truly be considered “informed.”