Blogs
Why are eCOA studies still so challenging? And, how can we make them better?
June 3, 2026
- COA licensing remains one of the biggest bottlenecks in eCOA study start-up, causing unpredictable delays and resource burdens.
- IRB screenshot requirements are largely a myth and submitting them is slowing down study launches.
- Fragmented sponsor, CRO, and vendor relationships create silos that increase risk; a true partnership approach is key.
18 months of FDA’s Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance – have we seen its impact?
May 26, 2026
- The FDA’s 2024 guidance recommends five standardized PRO domains for oncology trials to improve cross-trial comparability and regulatory utility.
- Despite regulatory momentum, adoption is still slow, with only ~13% of upcoming oncology studies referencing quality of life measures.
- PRO collection should start in early-phase trials, not just pivotal studies, to ensure the right measures are captured from the start.
Better Experience, Better Evidence: How Human-centered Design Changes Clinical Trials
April 14, 2026
- Patients first: Human-centered design reframes the mission to make trial participation fit naturally into patients’ daily lives, driving engagement and retention.
- Better experiences, better data: Intuitive design reduces participant burden, improves completion rates, and minimizes missing data.
- Inclusion by design: Mobile-first functionality, simplified interfaces, and remote participation options lower barriers and broaden access.
Clinical Trials Are All About the Data: Why Ensuring eCOA Stakeholder Alignment Is Critical
March 13, 2026
- Roles and responsibilities: Clear accountability among sponsors, CROs, and eCOA providers from day one is key to effective eCOA data management.
- Alignment and oversight: From system configuration and UAT to database lock, consistent communication and structured processes help to ensure data quality.
- AI as a force multiplier: AI tools like uMotif’s MotifAI Assistant can surface insights, detect anomalies, and flag at-risk participants earlier, supporting teams without replacing the human oversight.
Partners for Success: Governance Best Practices to Streamline eCOA Trial Launch
November 21, 2025
- Communication framework: Transparent information flow builds mutual understanding and keeps stakeholders aligned.
- Speed and accuracy: When challenges arise, rapid and well-coordinated responses keep study timelines on track and ensure consistent messaging across a client’s portfolio.
- Proactive and reactive governance: Strong governance anticipates issues, not just resolves them.
- Continuous learning: Reviewing completed studies and reusing proven best practices has reduced time to study launch by more than 30% for some clients.
Humans and AI share the spotlight at SCDM
October 6, 2025
- AI beyond hype: AI is driving real impact today, including speeding documentation, improving data quality, and freeing humans to focus on critical relationships.
- The human imperative: Humans—including patients, site coordinators, and data managers—are the users of clinical trial technology, and technology must serve people and not the other way around.
- Paper is still in use: Platforms must accommodate and clearly identify paper-sourced data.
Three questions (+) with Steve Lyons
September 30, 2025
Steve Lyons, uMotif’s VP of Data & Analytics, shares his perspective on:
- Integrating diverse data sources: Standardized APIs and automated validation normalize data from disparate sources with minimal manual effort.
- The future of data delivery: Real-time streaming and AI-driven data cleaning open new possibilities for adaptive study designs.
- Compliance and agility: A privacy-by-design architecture ensures speed never comes at the expense of safety.
Applying the Scientific Lens to Clinical Research Technology: The Chief Scientific Officer Perspective
September 24, 2025
- The CSO’s role: From reviewing study proposals to ensuring cross-functional alignment, the CSO bridges scientific rigor and technology to deliver compliant, successful trials.
- The scientific lens: Knowing not just if something can be done, but if it should, is critical to building client trust and delivering scientifically sound studies.
- Scientific leadership and industry progress: Engaging with the broader research community, including the eCOA Consortium, helps advance best practices and optimize clinical trial outcomes.
Three questions with Julia Lakeland
August 7, 2025
Julia Lakeland, uMotif’s Chief Customer Success Officer, shares insights on:
- Customer success: uMotif’s goal is to be every client’s preferred partner, walking alongside them from study design through completion with transparency, expertise, and trust.
- eCOA/ePRO best practices: Balance data richness with patient burden, and remember that eCOA is far more than a paper questionnaire on a screen.
- Trends shaping clinical trial technology: Participant centricity, caregiver-inclusive solutions, and the responsible adoption of AI are redefining how sponsors and CROs approach study design and execution.
The uMotif Care Cluster Solution: Capturing Quality Data from Participants & Their Caregivers
June 26, 2025
Florence Mowlem, PhD, uMotif’s Chief Scientific Officer, discusses uMotif’s new Care Cluster solution:
- The solution: uMotif’s Care Cluster enables data capture from multiple caregivers and participants, with clear attribution of exactly who is reporting.
- Use cases: uMotif’s Care Cluster is particularly valuable in pediatric trials with multiple caregivers, cognitive dysfunction studies, and other therapeutic areas like Parkinson’s where both participant and caregiver perspectives are essential.
- Why it matters: The solution addresses the challenges of clinical research studies collecting data from multiple reporters, facilitating the capture of high-quality, attributable data, while providing a user-centered experience.
How to build strong technology vendor and CRO partnerships that deliver for patients, sites, and sponsors
March 31, 2025
- The information gap: Protocols typically provide only two-thirds of what’s needed to configure eCOA software, which makes early, open communication between sponsors, CROs, and vendors critical.
- The foundation: Strong partnerships require a shared commitment to accountability and solving problems together.
- The kickoff: Bringing key stakeholders together from the start ensures alignment, closes knowledge gaps, and builds relationships that sustain collaboration.
- Shared accountability: Protocols evolve and the best teams flex together, balancing speed with quality and GCP-compliant processes.
Three questions (+) with Florence Mowlem
November 25, 2024
In the latest installment of our “Three questions with” series, uMotif Chief Scientific Officer Florence Mowlem, PHD shares her deep experience in providing scientific guidance in the development of eCOA/ePRO software, discusses challenges facing sponsors in adopting digital health technologies, and what excites her about the direction of patient-focused software.
SCDM 2024 – Opportunities and optimism abound for making clinical trials more patient- and site-centric
October 10, 2024
uMotif’s Bruce Hellman, just back from #SCDM, shares 3 key takeaways from the event—including powerful opportunities for making clinical trials more patient- and site-centric.
Three questions (+) with Steve Rosenberg
November 15, 2023
Hear from our Chief Executive Officer, Steve Rosenberg as he shares insights on the current eCOA/ePRO landscape—both adoption and competition—as well as how modern eCOA/ePRO systems must deliver an exceptional user experience to patients as well as sites.
My Take: Three biggest themes of the 2023 clinical trial conference season.
March 19, 2023
The Fall conference season is a wrap, and uMotif Chief Patient Officer/Co-founder Bruce Hellman shares his take on the three biggest themes resonating across the events. Read the blog to see if your list matches his.
Modern eCOA/ePRO: A people-first approach paves the way for better data collection
October 17, 2023
Chief Patient Officer and Co-founder, Bruce Hellman, discusses how modern eCOA/ePRO systems can pave the way for better, human-centric data collection.
SCDM 2023 – patient-centricity in clinical data management
October 19, 2023
In our latest blog, uMotif’s Chief Patient Officer and Co-founder, Bruce Hellman discusses his takeaways from his recent trip to San Diego for the 2023 Society of Clinical Data Managers (SDCM) 25th anniversary conference.
Pfizer’s initiative to return clinical trial data to patients recognizes participant contributions and sets the pace for the industry
October 5, 2023
uMotif’s Chief Patient Officer/ Co-founder, Bruce Hellman celebrates Pfizer’s decision to return individual clinical trial data to patients at scale – in an easy-to-understand format – and explores the impact of expanding data return to real time, when feasible.
What does it take to be a modern eCOA/ePRO platform?
August 6, 2023
uMotif’s Chief Product Officer, Julia Lakeland shares her knowledge on the qualities that define and distinguish modern eCOA/ePRO, and why they matter to sponsors, CROs, clinical trial sites, and most importantly patients.
Three questions with Ben James
July 14, 2023
As we continue our ‘Three Questions with’ series, uMotif’s Chief Design Officer and Co-founder provides insight into the importance of prioritizing human-centricity in the design of modern eCOA/ePRO platforms and shares his thoughts on the future growth of eCOA/ePRO.
OurBrainBank (OBB) to improve the quality of life for glioblastoma patients
July 20, 2023
Glioblastoma Multiforme (GBM) is the most invasive and lethal type of brain cancer. uMotif is honored to have known and collaborated with the Glioblastoma charity, Our Brain Bank and Founder, Jessica Morris – in her quest to improve and extend the lives of those with GBM.
Three questions with Bruce Hellman
June 21, 2023
uMotif’s Chief Patient Officer and Co-founder shares our vision for giving patients the best experience possible and provides insights into how sponsors and CROs can transform study protocols and the participant experience with ePRO/eCOA.
100 for Parkinson’s study
April 24, 2023
This study was designed to help participants learn more about their own health, better understand how technology can support people living with Parkinson’s, and build a research dataset to drive new insights.
Guidance on Use of Patient Experience Data in Real World studies – EU Perspectives
April 24, 2023
Patient insights are expected to become increasingly instrumental in optimising medicine development and regulatory decision making.
uMotif eCOA/ePRO Platform Helps to Expand Understanding of Hypoglycaemic Events
April 24, 2023
Patient engagement expert and uMotif sales leader Peter Robinson shares insight at the 2023 International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) – Feb. 22-25, Berlin.
CNS Summit 2022 Boca was buzzing with patient-centricity
April 24, 2023
Our Chief Patient Office Bruce Hellman attended the CNS Summit held in Boca Raton, Florida and discovered that true patient centricity is the way forward for patient trials.
ISPOR 2022 – The continued rise of the Patient Reported Outcome
April 24, 2023
Bruce Hellman Chief Patient Officer reflects on his key learnings from this year’s ISPOR assembly on the future of the life sciences industry.
Digital Era Expands Scope and Impact for Medical Affairs. Prepare to Rise to the Challenge
April 24, 2023
With the rise of digital technology expanding the role of Medical Affairs, our Chief Product Officer, Julia Lakeland explains how Medical Affairs has a critical role to play in serving as the bridge between patients and pharmaceutical companies to ensure patient safety and improve outcomes.
Three things I learned at the PCMG 2022 assembly – “ The ‘I’ of the Storm”
April 24, 2023
Bruce Hellman reflects on his time at the Pharmaceutical Contract Management Group annual assembly, highlighting key themes from the conference.
