Event Schedule

ALL TIMES ARE IN EASTERN STANDARD TIME

Auditing and scalability are vital concerns in an evolving clinical trial landscape

  • Considerations when looking for the right strategy for your organization
  • Must have criteria and why you need to have them
  • Establish effective vendor management procedures, ensure vendors are both flexible and customizable

The process to address evolving patient needs to provide the opportunity for
flexibility in trial conduct. Using a decentralized model to deconflict the rigidity of
traditional site based clinical research must be addressed.

  • Compile the ecosystem of distinct products and services to enable the digitization of trial execution
  • Discuss the requirements for regulatory expertise to support the creation of patient-centric experiences via innovation along with complex and evolving regulatory frameworks
  • Review the benefits for sponsors, sites, and patients from an integrative approach

In 2021, Tufts CSDD conducted a global study to characterize and assess the innovation adoption cycle for technologies supporting clinical research operations with particular emphasis on those technologies supporting virtual trials, and virtual elements of virtual trials. Results from this study will be presented.

  • Institute mandates for greater operational efficiency
  • Improve change management to streamline future adoptions
  • Map out adoption cycle times and drivers

    The method to collect clinical research data has significantly changed due to COVID related travel restrictions. To calculate performance and success there must adaptability to stay relevant to this new paradigm.

    • Source challenges with lack of viable metrics in decentralized trials
    • Discuss new analytic methodologies to measure the compliance, timeliness and quality in a decentralized trials environment
    • Harness the increase of data collection from virtual/telehealth visits, home health, and wearable’s

    Oversight of GCP is moving outside of the traditional realm of the investigative site with increased used of decentralized trials, bringing new processes, staff and technology into trial execution.

    • Expect that modalities will lead to uncertainty in ensuring GCP
    • Misconceptions of DCT quality risk vs. traditional study risk
    • Potential mitigations in DCT risk areas

    Unlocking the potential of the next generation of clinical trials will require transformative change in how we approach collecting and managing clinical data. In this session you will learn how to:

    • Move beyond CRFs and embrace eSource
    • Commit to collecting structured data as it will be vital
    • Increase the usefulness of the data collected and reveal previously-hidden insights

    Until a trial design is truly “siteless”, local research sites are key to a successful decentralized study. Despite their overall interest in being a part of the solution, the voice of the sites is often been left out in the planning and implementation of these studies leaving the suboptimal “Ready, Fire! Aim” approach.

    • Hear SCRA site landscape and global feedback to sponsors, CRO’s and technical providers
    • Discuss lessons learned in building site extenders
    • Drive increase recruiting strategies and retain a diverse trial population

    Day 1 Concludes
    ALL TIMES ARE IN EASTERN STANDARD TIME

    Hear how Moderna grew their digital structure and pivoted to challenge the industry like no one had before. Access a digital theme that is plug and play to finally overcome the obstacles facing sites, sponsors and talent.

    • Take an outside in view approach
    • Lessons learned and proven methodologies to scale DCT design capabilities
    • Approach talent and staffing challenges facing your organization

      COVID-19 has exposed glaring gaps in healthcare and health equity, especially in clinical trial reach and efficacy. Without integrating diversity and inclusion (D&I) from the start, firms are stuck in a loop of being too late when it's time to bring products to market. Ultimately, diversity helps to create more innovation to bring more therapies to more people.

      • Hear how D&I matters at every stage of a trial and identify D&I data elements are critical to a sound strategy
      • Understand diverse key opinion leaders (KOLs) during product development
      • Source data for long-term success to understand principal investigator profiles and clinical trial sites

        Pandemic challenges were hard on every but questionable the hardest hit could be the senior population in this trial. This case study will discuss the major challenges that needed to be overcome and the solutions that are here to stay.

        • Pivot to inpatient interview base to zoom visits for questionnaires
        • Strengthen testing capabilities such as virtual cognitive testing

        Abbott has had success working with physicians schedules using offline reviews. Implement procedures by removing calendar invites, enroll and screen patients on HCP's own time.

        • Employ eligibility committee reviews to support enrollment
        • Hear examples of verbiage to be used in study charters to include this type of offline review
        • Review the process and flow for screening and enrollment reviews

        Hear directly from a patient and caregiver about what they experienced during their clinical trial. Understand the anxiety and weight of going through a clinical trial with sickle cell anemia, all while going to school full time during a pandemic. When asked if they would do it again, they said 100%!

        • Discover a firsthand success story
        • Understand how to alleviate the burdens
        • Hear how DCT solutions could have eased the stress and time

        Pharma needs to begin with the end in mind: both the patient and the principal investigator are critical gatekeepers of adoption. Engaging patients more fully and making sure decentralized clinical trials are easing rather than increasing burdens will be crucial to using these models in the longer term.

        • Understand how lockdown increased the demand for more flexibility of patient assessments
        • Gather and reliably archive patient feedback on drug formulation and delivery
        • Turn a challenging time into a new opportunity, with flexible trial structures

        Conference Concludes