Latest news with #Medable
Yahoo
3 days ago
- Business
- Yahoo
Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access
New digital-first solution enables patient engagement and retention while maintaining scientific rigor throughout 15-year CGT trials PALO ALTO, Calif., May 28, 2025--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships. CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers. "Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors," said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. "With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor." Medable's digital-first LTFU offering includes: Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances. Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up. Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time. Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites. Learn more about Medable's new digital-based LTFU model at American Society of Clinical Oncology's (ASCO) 2025 Annual Meeting (May 30-June 3) in Chicago at Medable Booth #10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024. View source version on Contacts Media Contact: Lisa Barbadora, Barbadora INK for Medable+1 (610) 420-3413lbarbadora@ / media@


Business Wire
3 days ago
- Health
- Business Wire
Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access
PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution. Share CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers. 'Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors,' said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. 'With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor.' Medable's digital-first LTFU offering includes: Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances. Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up. Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time. Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites. Medable Booth # 10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024.
Yahoo
13-05-2025
- Business
- Yahoo
Medable Releases New Digital Oncology Trial Offering to Reduce Complexity for Sites, Sponsors, Patients, and Caregivers
Integrated solution with self-service capabilities simplifies trial experience for all PALO ALTO, Calif., May 13, 2025--(BUSINESS WIRE)--Medable Inc., a leading provider of clinical development and eCOA technology, today announced its next-generation digital oncology trial offering specifically designed to reduce operational complexity for sites and sponsors while meeting vulnerable cancer patients and their caregivers where they are with accessible, digital tools. Oncology trials have historically been complicated but are becoming increasingly complex due to factors like advanced precision medicine, biomarker incorporation, and the need for broader patient populations, leading to challenges in trial design, recruitment, and data management. At the same time, the FDA is increasingly emphasizing electronic Patient-Reported Outcomes (ePROs) in oncology trials to systematically capture patient perspectives on symptoms, side effects, and quality of life through digital tools, which is changing how sponsors run cancer trials. Medable's newest oncology trial solution combines AI, automation, and differentiated eCOA capabilities to simplify oncology trials with real-time, high-quality patient data capture, remote participation, and continuous oversight. Medable's solution streamlines workflows for sites, which are often managing multiple cancer studies, as well as sponsors and contract research organizations (CROs) that are building nuanced cancer trial protocols. As important, Medable puts patients at the center of the trial, making it easier to collect input directly from patients to turn their lived experiences into tangible data that drives cancer breakthroughs. Medable's digital trial platform is leveraged in global cancer trials across all four phases of research. The foundation of its oncology offering is AI-driven eCOA (including ePRO) technology. From data capture to real-time oversight, it enables the collection of high-quality patient data, including ePROs and digital measures, while supporting greater patient flexibility and delivering real-time oversight for a vulnerable population. Medable eCOA reduces patient burden – especially important in oncology, where protocol complexity is high and patients are often immunocompromised or fatigued – by digitizing assessments, shortening visit times, and enabling remote participation. It also includes protocol-ready libraries, rapid build capabilities, and site-friendly workflows that simplify execution and improve trial responsiveness. "Medable's digital trial platform is the engine that ensures every patient's voice is heard," said Musaddiq Khan, vice president of customer value and oncology lead at Medable. "It is specifically designed to address the biggest challenges in oncology trials, reducing complexity to speed processes with less burden on sites and greater clarity for researchers." Learn more at American Society of Clinical Oncology's (ASCO) 2025 Annual Meeting (May 30-June 3) in Chicago at Medable Booth #10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024. View source version on Contacts Media Contact: Lisa Barbadora, Barbadora INK for Medable+1 (610) 420-3413lbarbadora@ / media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


Business Wire
13-05-2025
- Business
- Business Wire
Medable Releases New Digital Oncology Trial Offering to Reduce Complexity for Sites, Sponsors, Patients, and Caregivers
PALO ALTO, Calif.--(BUSINESS WIRE)-- Medable Inc., a leading provider of clinical development and eCOA technology, today announced its next-generation digital oncology trial offering specifically designed to reduce operational complexity for sites and sponsors while meeting vulnerable cancer patients and their caregivers where they are with accessible, digital tools. 'Medable's digital trial platform is the engine that ensures every patient's voice is heard.'-- Musaddiq Khan, vice president of customer value and oncology lead at Medable Share Oncology trials have historically been complicated but are becoming increasingly complex due to factors like advanced precision medicine, biomarker incorporation, and the need for broader patient populations, leading to challenges in trial design, recruitment, and data management. At the same time, the FDA is increasingly emphasizing electronic Patient-Reported Outcomes (ePROs) in oncology trials to systematically capture patient perspectives on symptoms, side effects, and quality of life through digital tools, which is changing how sponsors run cancer trials. Medable's newest oncology trial solution combines AI, automation, and differentiated eCOA capabilities to simplify oncology trials with real-time, high-quality patient data capture, remote participation, and continuous oversight. Medable's solution streamlines workflows for sites, which are often managing multiple cancer studies, as well as sponsors and contract research organizations (CROs) that are building nuanced cancer trial protocols. As important, Medable puts patients at the center of the trial, making it easier to collect input directly from patients to turn their lived experiences into tangible data that drives cancer breakthroughs. Medable's digital trial platform is leveraged in global cancer trials across all four phases of research. The foundation of its oncology offering is AI-driven eCOA (including ePRO) technology. From data capture to real-time oversight, it enables the collection of high-quality patient data, including ePROs and digital measures, while supporting greater patient flexibility and delivering real-time oversight for a vulnerable population. Medable eCOA reduces patient burden – especially important in oncology, where protocol complexity is high and patients are often immunocompromised or fatigued – by digitizing assessments, shortening visit times, and enabling remote participation. It also includes protocol-ready libraries, rapid build capabilities, and site-friendly workflows that simplify execution and improve trial responsiveness. 'Medable's digital trial platform is the engine that ensures every patient's voice is heard,' said Musaddiq Khan, vice president of customer value and oncology lead at Medable. 'It is specifically designed to address the biggest challenges in oncology trials, reducing complexity to speed processes with less burden on sites and greater clarity for researchers.' Learn more at American Society of Clinical Oncology's (ASCO) 2025 Annual Meeting (May 30-June 3) in Chicago at Medable Booth # 10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024.
Yahoo
13-05-2025
- Business
- Yahoo
Medable Releases New Digital Oncology Trial Offering to Reduce Complexity for Sites, Sponsors, Patients, and Caregivers
Integrated solution with self-service capabilities simplifies trial experience for all PALO ALTO, Calif., May 13, 2025--(BUSINESS WIRE)--Medable Inc., a leading provider of clinical development and eCOA technology, today announced its next-generation digital oncology trial offering specifically designed to reduce operational complexity for sites and sponsors while meeting vulnerable cancer patients and their caregivers where they are with accessible, digital tools. Oncology trials have historically been complicated but are becoming increasingly complex due to factors like advanced precision medicine, biomarker incorporation, and the need for broader patient populations, leading to challenges in trial design, recruitment, and data management. At the same time, the FDA is increasingly emphasizing electronic Patient-Reported Outcomes (ePROs) in oncology trials to systematically capture patient perspectives on symptoms, side effects, and quality of life through digital tools, which is changing how sponsors run cancer trials. Medable's newest oncology trial solution combines AI, automation, and differentiated eCOA capabilities to simplify oncology trials with real-time, high-quality patient data capture, remote participation, and continuous oversight. Medable's solution streamlines workflows for sites, which are often managing multiple cancer studies, as well as sponsors and contract research organizations (CROs) that are building nuanced cancer trial protocols. As important, Medable puts patients at the center of the trial, making it easier to collect input directly from patients to turn their lived experiences into tangible data that drives cancer breakthroughs. Medable's digital trial platform is leveraged in global cancer trials across all four phases of research. The foundation of its oncology offering is AI-driven eCOA (including ePRO) technology. From data capture to real-time oversight, it enables the collection of high-quality patient data, including ePROs and digital measures, while supporting greater patient flexibility and delivering real-time oversight for a vulnerable population. Medable eCOA reduces patient burden – especially important in oncology, where protocol complexity is high and patients are often immunocompromised or fatigued – by digitizing assessments, shortening visit times, and enabling remote participation. It also includes protocol-ready libraries, rapid build capabilities, and site-friendly workflows that simplify execution and improve trial responsiveness. "Medable's digital trial platform is the engine that ensures every patient's voice is heard," said Musaddiq Khan, vice president of customer value and oncology lead at Medable. "It is specifically designed to address the biggest challenges in oncology trials, reducing complexity to speed processes with less burden on sites and greater clarity for researchers." Learn more at American Society of Clinical Oncology's (ASCO) 2025 Annual Meeting (May 30-June 3) in Chicago at Medable Booth #10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024. View source version on Contacts Media Contact: Lisa Barbadora, Barbadora INK for Medable+1 (610) 420-3413lbarbadora@ / media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data