INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • What Is A TMF Certified Copy?

    When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors: what constitutes a certified copy and when a certified copy is required. While recent regulatory guidance has helped determine best practices that eliminate some of this confusion, questions still remain. This article answers the most frequently and commonly asked questions about the certified copying process for TMFs.

  • How Should You Prepare For Foreign FDA Inspections During COVID-19?

    As the COVID-19 pandemic continues, it is important to understand the expectations of regulators about how to facilitate paper-based facility inspections in lieu of those performed on site.

  • How To Use Risk- Based Monitoring And Clinical CAPA To Ensure Compliance

    A robust clinical quality management system (CQMS) can help you mitigate risks, maintain high quality data and information across your trial sites, and ensure compliance throughout the life of your clinical research.

  • Good Clinical Practices And 5 Common GCP Violations In Clinical Studies

    Here we review what GCPs require of a clinical study, the regulatory requirements, and the most common issues cited in FDA inspections of clinical trials.

  • Choose The Right FDA Program To Expedite Your Rare Oncology Trial
    6/28/2021

    With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment options, researchers, clinicians, and patients may be seeking approaches to accelerate the development and approval of novel therapies. In this blog post, we review the regulatory programs available to expedite treatments for rare disorders and serious diseases.

  • Long-Term Follow-Up In Gene Therapy Trials: Ensuring Patient Engagement & Regulatory Compliance
    7/27/2020

    To understand and mitigate the risk of these delayed adverse events, participants in gene therapy trials may be monitored for a long-term follow-up (LTFU) period, which may be as long as 15 years. During this period, sponsors are challenged with navigating complex regulatory requirements as well as finding innovative ways to keep patients engaged for a decade or more.

  • Achieving The Promise Of Gene Therapy: New Pathways To Overcome Patient Enrollment And Safety Challenges
    10/19/2020

    This webinar examines the evolving science of gene therapy, covering current approaches such as gene transfer and gene silencing, safety considerations, and delayed adverse events. Learn about the current regulatory landscape, identify opportunities to more closely engage with regulators, and more.

  • 10 Things You Should Know About The New TMF Regulatory Guidance
    1/28/2021

    The new European Medicines Agency (EMA) guidance on Trial Master Files forms the most detailed guide to TMF best practices yet published by a regulatory agency, and in fact is becoming a de facto industry standard. Based on Phlexglobal’s extensive experience helping organizations successfully pass hundreds of regulatory inspections, following are 10 key developments that you should be aware of.

  • LSX 2021: The Path From Preclinical To And Through Clinical
    3/29/2021

    Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies, highlighting these products’ unique challenges as well as their powerful potential to address a broad array of unmet patient needs.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Start managing your IDMP data with Phlexglobal today! PhlexIDMP is a single regulatory database that will help you to avoid redundant data  that exists within your submissions. PhlexIDMP is based on two key components - controlled vocabulary management and codes - that deliver the best ready to use IDMP management solution.

  • TrialScope Clinical Trial Registry Manager (CTRM) delivers the proven solutions clinical trial sponsors need to centralize, track, register, and comply with clinical trial disclosure processes, mitigating compliance risks while giving them greater control over their own clinical trial disclosure reputation.

  • Best-in-class processes coupled with industry-leading technology to fight for your trial’s success.

  • Our regulatory consultants take action and move your research forward. If you’re looking for help in the development of innovative life science and digital health products, then Advarra® is the answer.

  • One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.