Case Study

Jaguar Gene Therapy

Jaguar Gene Therapy (www.jaguargenetherapy.com) is dedicated to accelerating breakthroughs in gene therapy for patients suffering from severe genetic diseases including those that impact sizable patient populations. The company is made up of a proven and growing team of experts with unparalleled CMC (Chemistry, Manufacturing and Controls), regulatory, clinical, and commercial acumen who have first-hand experience in bringing novel gene therapy treatments to patients and their families.

The Jaguar Clinical Operations team recognized that efficient data flow was critical to rapid execution of a clinical trial and struggled to find adequate Electronic Data Capture systems that met all the unique requirements necessary for their gene therapy studies. ANZU® offers unique patented video technology, broad experience in physician/patient engagement platforms and innovative design and execution, and was engaged to create an efficient, full-featured clinical trial platform that solved many of the challenges encountered with existing products. The Jaguar Clinical Operations team, which leverages over 40 years of combined experience in clinical operations and trial execution utilizing multiple Electronic Data Capture Systems, worked closely with the ANZU® technology team to design workflows for a multitude of features:

  1. Study Design and Administrative portals that optimize study Case Report Form design, configuration, delivery, and subsequent editing.
  2. Paired mobile and web-based technology to deliver real-time information to senior management, clinical operations, clinical sites, and the patients (and/or their caregivers). Mobile technology also allows secure communication channels, alerts, and full data entry/review capabilities.
  3. Incorporation of multi-media data capture. In previous roles at other pharmaceutical companies, the Jaguar team had pioneered the use of the video documentation of clinical outcomes after treatment in trials. They encountered a multitude of challenges in adding media to a trial, including slow video upload times, efficient facilitation, and documentation of video review by clinical site and centralized clinicians, and organization and presentation of video results. Utilizing their patented video bookmarking platform, ANZU® designed and built all the essential components to seamlessly solve these problems not only for video, but also images and audio files.
  4. Minimizing data entry errors, time-consuming source data verification (SDV), and data transfer and reconciliation for central laboratory data by utilizing ANZU’s agnostic LIMS interface which can directly pull data from the central lab and auto populate lab forms in real time.
  5. Add all the additional components required for efficient trial execution including:
    • Electronic Informed Consent (eIC)
    • Electronic Patient Reported Outcomes (ePRO)
    • Incorporation of electronic versions of SAE/AESI forms
    • Electronic Protocol Deviation logs that can capture all the necessary site and sponsor input in one location
    • Study-specific training Modules (Clinical Trials Learning Management System) for study site personnel and sponsor team members that track completion and compliance

Jaguar Gene Therapy is dedicated to accelerating breakthroughs in gene therapy for patients suffering from severe genetic diseases including those that impact sizable patient populations. The company is made up of a proven and growing team of experts with unparalleled CMC (Chemistry, Manufacturing and Controls), regulatory, clinical, and commercial acumen who have first-hand experience in bringing novel gene therapy treatments to patients and their families.

The Jaguar Clinical Operations team recognized that efficient data flow was critical to rapid execution of a clinical trial and struggled to find adequate Electronic Data Capture systems that met all the unique requirements necessary for their gene therapy studies. ANZU® offers unique patented video technology, broad experience in physician/patient engagement platforms and innovative design and execution, and was engaged to create an efficient, full-featured clinical trial platform that solved many of the challenges encountered with existing products. The Jaguar Clinical Operations team, which leverages over 40 years of combined experience in clinical operations and trial execution utilizing multiple Electronic Data Capture Systems, worked closely with the ANZU® technology team to design workflows for a multitude of features:

  1. Study Design and Administrative portals that optimize study Case Report Form design, configuration, delivery, and subsequent editing.
  2. Paired mobile and web-based technology to deliver real-time information to senior management, clinical operations, clinical sites, and the patients (and/or their caregivers). Mobile technology also allows secure communication channels, alerts, and full data entry/review capabilities.
  3. Incorporation of multi-media data capture. In previous roles at other pharmaceutical companies, the Jaguar team had pioneered the use of the video documentation of clinical outcomes after treatment in trials. They encountered a multitude of challenges in adding media to a trial, including slow video upload times, efficient facilitation, and documentation of video review by clinical site and centralized clinicians, and organization and presentation of video results. Utilizing their patented video bookmarking platform, ANZU® designed and built all the essential components to seamlessly solve these problems not only for video, but also images and audio files.
  4. Minimizing data entry errors, time-consuming source data verification (SDV), and data transfer and reconciliation for central laboratory data by utilizing ANZU’s agnostic LIMS interface which can directly pull data from the central lab and auto populate lab forms in real time.
  5. Add all the additional components required for efficient trial execution including:
    • Electronic Informed Consent (eIC)
    • Electronic Patient Reported Outcomes (ePRO)
    • Incorporation of electronic versions of SAE/AESI forms
    • Electronic Protocol Deviation logs that can capture all the necessary site and sponsor input in one location
    • Study-specific training Modules (Clinical Trials Learning Management System) for study site personnel and sponsor team members that track completion and compliance

Testimonials

The ANZU platform which can be customized to meet clinical trial operational needs has the potential to significantly reduce the timelines for trial execution that can translate to significant business impact for the company by shortening clinical development and regulatory path for a program to optimize access for the patient to a lifesaving product and enhance return on investment for the sponsor.

Sukumar Nagendran M.D.

President of Research and Development

Jaguar Gene Therapy

ANZU® was intent on creating a platform that could address multiple challenges for clinical trial data collection.  They really listened to understand where our roadblocks have been and how best to incorporate solutions throughout the platform that work well for clinical operations professionals.  The result is technological advances in multiple areas of data collection and trial execution, rolled seamlessly into one easy-to-implement solution.

Courtney Wells
SVP Clinical Affairs and Operations
Jaguar Gene Therapy