GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Ensuring Compliance With Part 11: A Site’s Perspective

    As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

  • The Electronic Trial Master File: Study Item And Placeholder Analysis
    5/21/2021

    Electronic trial master file (eTMF) systems are proving to be effective in planning, managing, monitoring, and maintaining inspection-readiness and compliance. This paper explores the use of planning wizards and how placeholder creation promotes study completeness, timely document uploading, and reduced rates of quality control failures. These features can ease workloads while providing the transparency needed for inspections and audits.

  • COVID-19 Vaccine Development: Building On A Legacy Of Innovation
    3/31/2021

    The SARS-CoV-2 virus at the center of the COVID-19 pandemic may be novel, but the coordinated research and development efforts to create a vaccine for it are not entirely so. They borrow from experiences derived from more than 50 years of successful vaccine development programs. Read Worldwide’s take on the history of medicine and the development of the coronavirus vaccine.

  • The H1N1 Study: Conducting Public Health Research During A Pandemic
    4/7/2020

    This article describes Rho’s involvement in a recent clinical trial that assessed the safety and immunogenicity of the 2009 H1N1 vaccine in adults and children (aged 12-79 years) with severe asthma.

  • ALS Studies And Lessons Learned From COVID-19
    2/2/2021

    For ALS trial sponsors and CROs alike, the need to protect the health of study participants, the study team, on-site health care professionals, and the broader community in which the trial centers are located is of paramount importance. The question is, how to ensure this protection and conduct the trial? The answers lie in preemptive mitigation and adaptive processes that can be implemented flexibly as conditions evolve.

  • Risk Based Quality Management (RBQM) - A Collaborative Approach To Holistic Clinical Trial Oversight
    11/25/2019

    Developing, executing, and overseeing clinical trials is a complex process. This paper shares perspectives that will assist sponsor organizations in the creation of a RBQM system in partnership with their CROs and vendors. When a shared, proactive plan is established, sponsors and CROs/vendors can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Cleaning Up Patient Data … Quickly
    3/2/2020

    A sponsor needed to deliver data so a go-/no-go decision could be made at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat impersonal CRO and a small sponsor that was used to close personal relationships and more or less constant interaction with the team managing its studies. We picked up the project in March 2013 and completed data lock by the end of September.

  • Midlantic Urology Associates Introduces Added Convenience For Patients With Rideshare Program
    7/15/2019

    Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.

  • A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)
    8/5/2020

    Clinical development service provider efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting.

  • Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe
    1/14/2021

    Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.

  • Phase III Rare Disease Rescue
    1/2/2020

    A small biotech with limited internal capacity outsourced a phase III clinical program in patients with Necrotizing Soft Tissue Infections. After nearly 16 months, patient enrollment was still a major challenge, the study was over budget and CRO staff turnover on the project was extremely high. Catalyst provided a blinded and unblinded monitoring team that reported into the Sponsor’s CTM using Catalyst’s SOPs allowing the Sponsor to retain control of their program.

  • A High Unmet Need That No One Wanted To Talk About
    3/2/2020

    What do you do when patients are too embarrassed to talk about what’s wrong with them? Recruiting “hidden” patient groups for rare disease studies is always challenging, and flexibility is the only constant.

CLINICAL LEADER CONTENT COLLECTIONS

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