eConsent
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some organizations have held tight to a method of clinical trial conduct that’s increasingly as outclassed as it is outdated.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.
The Definitive Guide to Digital Evidence Generation
According to Grandview Research, the hybrid and decentralized clinical trial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient-centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct. Sponsors are increasingly turning to DCT platforms in alignment with the rise of Life Science and Software-as-a-Service (SaaS) solutions. For those who haven't made the jump yet, there are many questions, including "What is a decentralized clinical trial?" Find out with this in-depth guide to decentralized clinical trials. Uncover how they work, their benefits, and how they transform clinical development.
Back to basics: What is electronic informed consent (eConsent)
While informed consent form (ICF) signatures traditionally have been collected on paper at a physical site, today’s digital approach — electronic consent (eConsent) — offers more than high-tech signature collection. It provides an upgrade to patient education and communication as well, empowering participants in new ways. Moreover, eConsent can democratize clinical trial access, allowing researchers to recruit broader and more diverse participant groups through entirely remote consenting processes. This broader and less burdensome access also can increase the speed of recruitment and reduce drop-out rates.
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.
What it really takes to adopt eConsent across large pharma
Learn about the benefits of adopting consent management technology and best practices around developing change management and training programs to help sponsors, CROs and sites get the most out of eConsent.
ePROs: Transforming oncology research
In this webinar, VP of Digital Trial Solutions Musaddiq Khan, VP of Product Strategy Colin Weller, and Cancer Survivor Lindsey Matt discuss how Medable is supporting a patient-first approach in complex Oncology clinical trials
Digital vs digitized: Common myths about eConsent for clinical trials
Alex Burrington, CTI Principal of Vertex, and Andrew Mckinnon, VP, GM of eConsent discuss common myths around eConsent, how to improve comprehension with patient-centric consent, and how to use a digital consent management tool to improve trial compliance, quality, and oversight.
White paper: Why eConsent primes patients and studies for success
Read this white paper to learn how eConsent's flexibility helps you educate and retain patients worldwide, regardless of signature requirements, and how to implement it across your organization.
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.
White paper: The foundations of decentralized clinical trials
Understand the benefits of web-enabled research tools and how they work.
Improve trial enrollment using patient perspectives and technology
In this webinar, Nisha Trivedi, Patient Advocate, and Jena Daniels, VP of Patient Success showcase how adding technology in clinical trials enables greater diversity and an increase in study enrollment upfront and maintains patient engagement over the course of the study.
Webinar Highlights:
- Establishing internal relationships with end-users (patients, caregivers, and sites) will increase technology adoption
- Using technology to increase participant access, engagement, retention, and education
- Navigating uncertainties in technology and approach while balancing the needs of participants providing them with a positive and differentiated experience
- Ensuring patients, caregivers, and sites are engaged in the study design and implementation process
White paper: The building blocks of DCT. How to create a seamless experience across eConsent, eCOA and more
Combining multiple market solutions at the site level can result in a negative experience due to different processes, login credentials, and redundant training. A unified DCT platform that works seamlessly with other core clinical systems to streamline workflows and simplify key trial processes.
Where does patient recruitment end and patient engagement begin?
It’s widely understood that patient recruitment is one of the most critical and yet most challenging aspects to a successful clinical trial. In fact, many trials fail to reach recruitment goals, with far-ranging implications for investigators, sponsors, study participants, and the population affected by the disease or condition under study.