News & Events

Vivli CEO Rebecca Li to participate in panel discussion about data sharing under new Department of Justice rule

On September 17, Vivli CEO Rebecca Li, PhD, will speak at the PHUSE Data Transparency Autumn Event. This free, virtual event offers an opportunity for attendees to collaborate on ideas related to data transparency and data sharing. Data managers, biostatisticians, and other professionals interested in data sharing are encouraged to attend.

Dr. Li’s presentation, “Navigating Data Sharing Compliance Under the US DOJ Final Rule on Transfers of Sensitive Personal Data to Countries of Concern – Operational Impacts,” will be from 10:30 a.m. to 12:30 p.m. ET and will focus on privacy-preserving techniques, data anonymization, and governance frameworks. The panel presentation will respond to recent technological and geopolitical developments, including a rule recently issued by the U.S. Department of Justice. Register to attend this free, virtual event.

Vivli Researcher Spotlight: Examining survivor function data across multiple trials for kinetics of stroke recurrence

James Brorson is a professor of neurology at the University of Chicago, with a research focus on vascular neurology. He has more than 25 years of patient care experience, as well as laboratory and clinical research. He has served as a principal investigator for several clinical trials in secondary stroke prevention, and currently serves as medical director of the University of Chicago Comprehensive Stroke Center, which cares for more than 400 stroke patients annually.  

Dr. Brorson’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Examination of survivor functions from SOCRATES and THALES trials for kinetics of stroke recurrence.” The team’s completed research has recently been presented to the research community in publications including Neurology and Stroke

Stroke is a common and often devastating condition in which blockage of blood flow to a part of the brain leads to its destruction, with corresponding loss of function, producing a variety of symptoms. Stroke is a leading cause of death and long-term disability globally. In the United States, some 800,000 persons suffer strokes each year, and more than 100,000 die.

A person who suffers a first stroke classified as mild is at increased risk of a second, often more severe stroke. The risk of recurrence is highest in the immediate aftermath of the first stroke, and prevention efforts frequently concentrate in the 12-24 hour period following the first incident. The rate of recurrence declines over time, and researchers have theorized that examination of the time course for the timing and rates of stroke recurrence may provide insight which may help with devising better ways to prevent recurrent strokes. 

Dr. James Brorson and a team of colleagues set out to harmonize, merge, and assess data gathered from participants in three large trials in the aftermath of a first stroke event. Their aim was to determine whether treatment decisions could be made more precisely based upon analysis of timing and rates of stroke recurrence. They accessed data from more than 25,000 participants in order to provide sufficient statistical power to detect modifiers of early and late kinetics of stroke recurrence.

To carry out their analysis, the team developed a two-state kinetic model of stroke recurrence. This model proposes an initial vulnerable state with a higher rate of stroke recurrence, which rapidly transitions to a stabilized state with a lower rate of recurrence. They further theorized that this model would fit the survival data for each of these recent trials of acute secondary prevention better than would a model assuming only a single clinical state after the initial minor stroke.

The team’s findings established that recurrence of stroke is well-described by a two-state kinetic model postulating vulnerable and stabilized states, with similar kinetic parameters across the three trials. Their analysis also indicates that enhanced antiplatelet regimens only affected the recurrence rates during a brief period in the vulnerable state. This suggests that two distinct states follow acute cerebral ischemic events, and that these states are subject to differential impact of immediate or delayed therapies. 

These findings have been published in the academic journals Neurology and Stroke. The authors are also working on a second phase of this project to harmonize and curate the data from the first phase into a single large dataset. When complete, they plan to re-share this dataset on the Vivli data repository to support further research in this area, providing additional opportunities for analysis and identification of new methods to prevent stroke recurrence.

 

Read more about Dr. Brorson’s research:

Examination of survivor functions from SOCRATES and THALES trials for kinetics of stroke recurrence (Vivli Research Request 6550)

Vulnerable and Stabilized States After Cerebral Ischemic Events: Implications of Kinetic Modeling in the SOCRATES, POINT, and THALES Trials (Neurology

Abstract WMP61: Vulnerable And Stabilized States After Cerebral Ischemic Events: Implications Of Kinetic Modeling In The POINT, SOCRATES, And THALES Trials (Stroke)

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

 

Alfasigma joins Vivli as a member to share data

“We are delighted to have Alfasigma join as a member of Vivli,” said Rebecca Li, Vivli CEO. “We look forward to working with the team at Alfasigma to share data to meet their data sharing commitments.”

For more information about the conditions for accessing Alfasigma data, please visit their member page. Learn more about membership in Vivli.

 

Vivli is hiring a Clinical Trial Transparency Associate

VIVLI, the Center for Global Clinical Research is seeking a Clinical Trial Transparency Associate. Vivli is a mission-focused non-profit and to help manage our continued growth, we are looking for a seasoned Clinical Trial Transparency Associate to join the operations team. The operations team supports researchers seeking to access datasets from contributors and provides support for data contributors.

Location: Remote, working core hours of 9am-5pm Eastern time zone, with the ability to travel 3-4 times per year.

Responsibilities will include but not limited to:

  • Manage day-to-day data request review process for specific requests following strict SOPs.
  • Work closely with Vivli end users to ensure researchers and members meet assigned requirements on specific requests.
  • Help manage approved research projects when in the analysis stage all the way through to project closeout.
  • Manage and help contribute to projects related to Vivli’s mission.
  • Testing new platform features and writing instructions for users on how to use those features, as required.
  • Perform other duties when requested.

 Qualifications

  • Minimum 3 years’ experience managing data transparency processes, either at an existing repository, platform or as a data contributor
  • Understanding of global regulatory requirements for clinical trial disclosure, preferred
  • 1-2 years managing data sharing agreements, including working with academic contracting offices
  • 1-2 years of experience working in an academic medical center or academic research center, preferred
  • Understanding of clinical trials processes and/or clinical data management, preferred
  • Excellent written and oral communication skills and interpersonal skills
  • 2-3 years of prior experience with following agreed SOPs and process improvement
  • Computer proficiency in MS Office, Excel, PowerPoint, Dropbox etc.
  • Excellent organizational skills and high attention to detail and accuracy
  • Ability to manage projects and resources
  • Bachelor’s degree in the health profession or science field.

Must be authorized to work in the United States.

What We Offer

  • Comprehensive benefits package, including health, dental, and vision insurance.
  • Opportunities for professional growth and development
  • Flexible work arrangements
  • A dynamic and collaborative workplace culture
  • Meaningful work that makes a real difference in the world

How to Apply

Interested candidates should submit their resume and a cover letter to hr@vivli.org

Vivli is hiring a UX Lead Engineer

VIVLI, the Center for Global Clinical Research, is seeking a UX Lead Engineer. Vivli is a mission-focused non-profit and to help manage our continued growth, we are looking for a UX Lead Engineer to join the development team to help us continue to improve and grow.

Location: Remote, working core hours of 9am-5pm Eastern time zone, with the ability to travel 3-4 times per year.

Job Description: 

We are seeking a dynamic UX Lead Engineer with Software Engineering Expertise to shape the future of our user experience. This hybrid role requires a visionary approach to user-centered design combined with a solid technical foundation in software engineering. You will lead a cross-functional team to deliver engaging, scalable, and accessible digital products that align with our business goals and technical capabilities.

Key Responsibilities:

Leadership & Strategy

  • Define and lead the UX vision and strategy to enhance product usability and user satisfaction.
  • Drive collaboration between design, engineering, and product teams to ensure a cohesive user experience.
  • Advocate for user-centered design across the organization and champion the voice of the user.

Design Execution

  • Oversee the end-to-end design process, including user research, wireframing, prototyping, and usability testing.
  • Ensure design consistency and quality across all platforms through the creation and maintenance of design systems.
  • Partner with stakeholders to translate business requirements into intuitive, functional, and visually appealing interfaces.

Technical Integration

  • Collaborate with software engineering teams to bridge the gap between design and development, ensuring feasibility and fidelity.
  • Write and review code where necessary, leveraging knowledge in front-end frameworks (e.g., React, Angular, or Vue.js) and tools.
  • Drive innovative solutions through the integration of design principles with modern engineering practices.

User Research & Analytics

  • Lead qualitative and quantitative user research to inform design decisions and identify user pain points.
  • Leverage analytics tools to monitor user behavior and improve key performance indicators (KPIs).
  • Conduct usability testing to validate designs and iterate based on feedback.

Team Development

  • Establish best practices for collaboration between design and engineering teams
  • Promote diversity, equity, and inclusion within the design process and team culture.

 Qualifications

Required:

  • Bachelor’s or Master’s degree in UX Design, Human-Computer Interaction, Computer Science, or a related field.
  • 3+ years of experience in UX design.
  • 3+ years of Software Engineering experience.
  • Strong technical foundation in front-end development (e.g., HTML, CSS, JavaScript) and frameworks like React or Angular.
  • Demonstrated success in leading complex design projects from concept to delivery.
  • Knowledge of accessibility standards (e.g., WCAG) and their implementation.
  • Excellent communication and collaboration skills, with the ability to articulate design decisions to technical and non-technical stakeholders.
  • Authorized to work as an employee in the US, with the ability to work core hours in the US Eastern time zone (no C2C or sponsorship).

Preferred:

  • Experience designing and developing for scalable enterprise applications.
  • Experience with design tools such as Figma, Sketch, or Adobe Creative Suite.
  • Familiarity with Agile and Lean UX methodologies.
  • Knowledge of back-end technologies and APIs to enhance collaboration with full-stack teams.
  • Portfolio showcasing a blend of design leadership and technical problem-solving

What We Offer

  • Comprehensive benefits package, including health, dental, and vision insurance.
  • Opportunities for professional growth and development
  • Flexible work arrangements
  • A dynamic and collaborative workplace culture
  • Meaningful work that makes a real difference in the world

How to Apply

Interested candidates should submit their resume and a cover letter to hr@vivli.org

Version 3.5 of the Vivli platform released

Version 3.5 of the Vivli platform has been released and is available to users.

The key changes with the new version of the platform are:

  • Improved dashboard for researchers once they create an account
  • Improved information for researchers when they access the secure research environment
  • Software and tools available in the Vivli research environment has been updated

“We have listed to feedback from researchers and wanted to update the information that they receive when they log on to the platform and the secure environment,” said Julie Wood, Vivli COO. “We think this will make it easier for researchers to find resources for additional guidance.”

Other usability features have been added and Vivli how to guides have been updated.

Brown University joins Vivli to make it easier for its researchers to share their clinical research

“We are delighted to have Brown University join as a member of Vivli, and to play a part in institutional investments in the research enterprise,” said Rebecca Li, Vivli CEO. “We look forward to supporting Brown researchers and staff to meet their commitments to funders to share their data.”

For more information about the conditions for accessing Brown data, please visit their member page. For additional information about Membership in Vivli, learn more here.

Vivli Researcher Spotlight: Examining serological status to better understand treatment response in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disorder, which primarily affects the joints and is characterized by inflammation and pain. RA most commonly affects the hands and wrists, but can also affect other parts of the body. There is currently no cure for RA, but treatment options have improved considerably in recent years with the development of new therapies and treatment strategies.

Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are well established as a standard treatment for RA, used to slow down progression of the disease through broad restriction of the immune systems. Biologic DMARDs (bDMARDs) take a more targeted approach, but it is unclear if it is equally effective across the spectrum of types of RA. In particular, the serological status of people diagnosed with RA may be linked to long-term outcomes. Also,  based on differences in associations with genetic and environmental risk factors, seropositive and seronegative disease are presumed to have different underlying pathophysiological mechanisms. However, whether serological status may also affect treatment responses to biological disease-modifying anti-rheumatic drugs (bDMARDs) is not completely clear. 

In a recently completed study, Dr. Kaoru Takase-Minegishi and colleagues undertook a meta-analysis based on a systematic literature review including data from 28 randomized controlled trials (RCTs). The research team’s goal was to investigate whether the efficacy of bDMARDs differs in seropositive RA patients (seropositive) compared to those classified as seronegative. Some of the study participants were also receiving csDMARDs, while other were treated bDMARDs exclusively.

The research findings indicate that seropositivity was not associated with a better response to bDMARDs, regardless of whether patients were also receiving csDMARDs. Other outcomes mostly showed no significant difference between the groups, and efficacy was generally comparable between seropositive and seronegative patients for a range of treatment protocols. 

Using the Vivli platform enabled the research team to include previously unpublished data, the first opportunity to perform meta-analysis on this complete dataset. Previously unpublished data are included in the Supplementary Material, available online alongside the article recently published in the journal Rheumatology. This research provides a very important additional perspective to the data reported from observational studies thus far, uncovering essential differences. 

Read more about Dr. Takase-Minegishi’s research:

Effect of rheumatoid factor and anticitrullinated peptide antibody on the efficacy of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis (Vivli Research Requests 4922, 3274)
The Impact of Autoantibodies (RF and ACPA) on the Efficacy of Biological Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis: Meta-analysis of Randomized Controlled Trials (Abstract, American College of Rheumatology Convergence 2022)
The impact of autoantibodies (RF and ACPA) on the efficacy of biological disease-modifying antirheumatic drugs in rheumatoid arthritis: meta-analysis of randomized controlled trials (Annals of the Rheumatic Diseases)
The impact of autoantibodies on the efficacy of biological disease-modifying anti-rheumatic drugs in rheumatoid arthritis: meta-analysis of randomized controlled trials (Rheumatology)

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

Vivli CEO Rebecca Li to participate in panel discussion for Harnessing the Potential of Patient-Level data in Clinical Trials     

Vivli’s CEO, Rebecca Li, will speak on Day 3 at the Global Clinical Trials: Technology & Innovation webcase series. This online event will take place on May 14-16, 2024. Li will participate as a panelist in a discussion session on ‘Harnessing the Potential of Patient-Level data in Clinical Trials.’

Explore the practical benefits of patient-level datasets in clinical trial as industry experts discuss strategies for implementing fully consented patient data and its impact on trial outcomes. The panel will be held on Thursday, May 16th, 5pm CEST / 4pm BST / 11am EDT. Learn more and register here.

ONO joins Vivli as a Member to Share its Data

“We are delighted to have ONO join as a member of Vivli, particularly given its rich and long history,” said Rebecca Li, Vivli CEO. “We look forward to working with the team at ONO to share their data to meet their data sharing commitments.”

Ono believes that sharing clinical study data and results with researchers, healthcare professionals, and patients contributes to the promotion of scientific studies and medical research, thereby leading to public benefits. Ono shares clinical study data in accordance with the guidelines stipulated in the “IFPMA Principles for Responsible Clinical Trial Data Sharing” presented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) dated January 15, 2018, as well as in compliance with industry guidelines including Good Publication Practice, applicable laws, and regulation.

For more information about the conditions for accessing ONO data, please visit their member page. For additional information about Membership in Vivli, learn more here.