News & Events

Vivli is hiring a Clinical Trial  Disclosure Specialist

VIVLI, the Center for Global Clinical Research, is seeking a Clinical Trial Disclosure Specialist. Vivli is a mission-focused non-profit and to help manage our continued growth, we are looking for a detail-oriented Clinical Trial Disclosure Specialist to join the operations team. The operations team manages the governance process to help researchers seeking to access to datasets from contributors.

Location: Remote, working core hours of 9am-5pm Eastern timezone.

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.
  • Support researchers with enquiries and related requests and follow ups.
  • Manage and help contribute to projects related to Vivli’s mission.
  • Contribute to process improvements to make the data request process more efficient for researchers and data contributors.
  • Perform other duties when requested.

 Qualifications

  • Minimum 2 years prior experience managing data disclosure processes, either at an existing repository, platform or as a data contributor
  • Understanding of global regulatory requirements for clinical trial disclosure, preferred
  • 2 years of experience working in an academic medical center, industry or government 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.

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

Must be authorized to work in the US. Interested candidates should submit their resume and a cover letter to hr@vivli.org

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.

Vivli Researcher Spotlight: Rethinking Rheumatoid Arthritis Management: The Dual Target Strategy

Rheumatoid arthritis (RA) poses a significant challenge due to its chronic nature and impact on joint health. While treatments have evolved, achieving remission remains elusive for many patients. Using a dataset from the Vivli repository, Dr. Ricardo Ferreira and a team of researchers delved into examining the assessment criteria for remission in RA, shedding light on the limitations of current approaches and proposing a new model—the dual target strategy.

The current standard of treatment is the Treat-to-Target (T2T) approach, which aims for remission or low disease activity. Dr. Ferreira’s team questioned the reliance on a single criterion, the patient global assessment (PGA/PtGA), included in composite measures for determining remission. Their study, drawing from extensive clinical trial data, notably revealed that 19% of patients failed to attain remission based solely on this patient-reported assessment, leading the team to explore a more comprehensive model. In a recent conversation with Vivli, Dr. Ferreira highlighted the research’s key finding: the lack of significant difference in radiographic outcomes between patients classified as “PGA-near-remission” versus those in full remission. This challenges the established understanding of remission incorporating the patient global assessment.

The research team has proposed a dual target strategy, which integrates patient-reported outcomes with objective measures like inflammation status and joint counts to assess inflammatory status and guide immunosuppressive therapy management. The second target (disease impact) would be assessed by informative patient-reported outcome measures, other than PGA. By assigning equal significance to subjective experiences and clinical data, this innovative approach proposes a new benchmark for remission in RA management. Moreover, it has the potential to guide both pharmaceutical and nonpharmacological interventions.

It is anticipated that the dual target strategy has a more patient-centric approach; integrating subjective experiences with objective clinical markers holds promise for improving treatment efficacy and enhancing patient outcomes. With key RA researchers expressing interest in this model, the dual target strategy could significantly change both RA management, and the experience of patients navigating this complex condition. A pragmatic, multicenter, randomized controlled trial is currently being prepared to test this strategy.

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 Researcher Spotlight: Reusing Data from a Completed Clinical Trial to Inform Guidelines

In a recent study led by Dr. Sarah Nevitt, a senior research associate at the University of Liverpool, a team of researchers examined the effectiveness of various antiepileptic drugs (AEDs) used as monotherapy for people experiencing seizures due to epilepsy. Epilepsy, a common neurological disorder, results from abnormal electrical discharges in the brain, causing recurrent seizures. Typically, around 60% to 70% of individuals with epilepsy achieve longer-term remission, often shortly after beginning treatment with antiepileptic drugs.

Dr. Nevitt and her team sought to compare the performance of 12 different AEDs in terms of treatment failure, remission, and occurrence of first seizures among both children and adults with focal onset or generalized tonic‐clonic seizures. They analyzed data from an extensive collection of clinical trials encompassing more than 22,000 participants, incorporating individual patient data from various studies using a network meta-analysis.

The analysis revealed some key insights. Older drugs like phenobarbitone and phenytoin demonstrated better seizure control for both focal and generalized seizures but had poorer long-term retention rates compared to newer medications such as lamotrigine and levetiracetam. Sodium valproate emerged as the top choice for achieving control and remission of generalized tonic‐clonic seizures, although it might not be suitable for everyone, especially people of childbearing age, due to associated risks.

These findings, published in the Cochrane Library, have already influenced the update of UK guidelines in 2022, providing immediate impact on the treatment of individuals newly diagnosed with epilepsy in the UK. In a recent conversation with Vivli, Dr. Nevitt highlighted that these results are guiding the approach to epilepsy treatment, emphasizing the importance of considering both efficacy and potential side effects when selecting appropriate medications for individuals experiencing seizures.

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.