INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • Effective Way To Ensure Early Statistical Deliveries

    A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

  • EMA Expands Use Of Remote Source Data Verification

    The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials. Read how the updated guidance justifies the use of rSDV on more trials with fewer restrictions.

  • Vendor Oversight – Ensuring Regulatory Compliance By Assessing Study Risks

    ICH E6 (R2) introduces the concepts of vendor oversight and risk management, but have these requirements been implemented jointly or as separate initiative’s today? Is study risk also being taken into account in vendor oversight? In this webcast we will explore the intended purpose of ICH regulations to implement industry best-practices, how current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidance’s and how by implementing QbD in your operational processes you can ensure study risk assessment in your vendor oversight – end-to-end.

  • New Developments In IDMP: What You Need To Know, And What You Can Do Today

    The Identification of Medicinal Products (IDMP) initiative from the ISO continues to progress and take shape, with timelines starting to firm up. While there is still much work to be done, agencies such as the EMA have already taken several concrete steps to help organizations prepare for IDMP. In this Executive Brief, Phlexglobal’s regulatory and technology experts examine the latest major development from the EMA.

  • Conducting Successful Oncology Trials In The Asia-Pacific Region
    8/9/2022

    Explore the advantages of conducting oncology clinical trials in the APAC region as we share strategies to help ensure study success.

  • 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.

  • Phlexglobal Innovation Tour 2020: Industry Survey Results & Expert Analysis
    1/25/2021

    On July 15, 2020, we launched the Phlexglobal Innovation Tour to bring together experts from across our industry to discuss clinical and regulatory related topics and explore innovative approaches to making compliance faster, easier, and better. What follows are the results of focused audience polls done during each session and afterwards together with the thoughts of our Innovation Tour experts

  • How Should You Prepare For Foreign FDA Inspections During COVID-19?
    2/25/2021

    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.

  • New FDA Certificate of Confidentiality Guidance: What Does It Mean For You?
    1/12/2021

    FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures Act (“Cures Act”), which was passed in 2016. In this blog we discuss what has and has not changed regarding CoCs and how this new guidance impacts research sponsors, research sites, and institutional review boards (IRBs).

CLINICAL TRIAL REGULATORY SOLUTIONS

  • 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.

  • PhlexSubmission is a robust, highly configurable and easy-to-use publishing engine for electronic submissions such as eCTD, NeeS VNeeS but also it can provide paper publishing capabilities for CTD and any custom type submissions that might be required.

  • Global clinical trial disclosure poses a challenge for many sponsors due to disparate tracking tools, teams located around the world and constantly changing regulations. However, sponsors can reduce risk with real-time access, metrics and answers.

  • Preparing regulatory marketing applications to their successful conclusions is our focus.

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