PALO ALTO, Calif.– Medable Inc., the leading SaaS platform for patient-centered clinical research, today announced new software solutions that enable life sciences companies to expedite critical vaccine development and quickly respond to outbreaks like COVID-19, monkeypox and new flu variants. The solutions include pre-configured modules for vaccine clinical trials that increase operational efficiency based on industry best practices, while cutting deployment times from more than 12 weeks on average to as little as five weeks.
Vaccine trials stand to benefit from a decentralized methodology, given the need for global remote access; fast results across a high volume of participants; low operational complexity compared to other trials; and high reliance on patient-reported outcomes. To date, however, uptake has been limited by the need for fast study startup – which caused organizations to default to known but inefficient and less robust manual paper processes, rather than shift to new digital approaches.
Medable’s new patient-first data collection solutions enable faster vaccine trials, better site and patient experiences, and expedited data delivery. Scalable options include:
- The “core” vaccine offering is built for speed, including a pre-configured set of modules – including pre-screening, eConsent, eCOA, TeleVisit, real-time data reporting and custom notifications – that enable sponsors to deploy in as little as five weeks while meeting industry standards.
- The “flex” vaccine offering provides the same core tools along with custom-designed digital products to meet specific protocol needs – including automated data access via sensors and wearables; more complex clinical outcome assessments; integration with additional EDC, IRT and clinical systems; and additional language support.
“Speed, access and data quality are all critical for vaccine trials, and we’ve worked hard to enable all three with Medable’s decentralized trial platform,” said Musaddiq Khan, vice president and head of Therapeutic Area Solutions at Medable. “By codifying the most common elements across vaccine trials, we minimize the need to do a ground-up build for every new study. That not only speeds up deployment, it allows for more robust remote data collection and broader global access to reach vaccine-naïve parts of the world.”
Medable’s new vaccine solutions come at a time when the life sciences industry has renewed its focus on vaccine studies and the accelerated delivery of new treatments. Mobile, cloud and digital technologies offer new methods to support and accelerate the innovations in vaccine science, such as breakthroughs in messenger RNA, without compromising patient safety or data integrity. “COVID-19 was a wake-up call for pandemic readiness, and vaccine demand and understanding has never been higher,” said Khan.
“As we know, one of the pain points for study participation continues to be hesitancy based on perceived disruptions to our daily lives,” said Allison Kalloo, MPH, who is a minority patient recruitment specialist and vaccine trial participant, and member of Medable’s Patient Advisory Council. “Vaccine trials can benefit from a prepackaged solution that can ease access and compliance while better managing expectations.”
Katie Moureau is another patient advocate who sees the benefits of decentralized vaccine trials to meet the needs of her five boys, ranging in age from 13 years to 22 months. “As a parent of a child with respiratory vulnerabilities, decentralized vaccine studies are beneficial not only for my seven year old, but all those who have immunocompromised systems. Having speedy communication and all things easily accessible is important to their health and safety. More efficient vaccine trials can influence whether my boys and others continue to participate or drop out, thus preventing unnecessary delays while protecting those who are really vulnerable.”
Medable’s clinical trial software platform has been used in more than 300 decentralized and hybrid clinical trials in more than 60 countries, serving over one million patients and research participants globally. Medable customers have achieved impressive results – including 200 percent faster enrollment and 50 percent cost reductions. A new study from Tufts Center for the Study of Drug Development shows that decentralized trials can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI respectively.
