INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • Planning The Way Forward In Neurodegenerative Disease Studies

    The recent FDA guidance entitled "Human Gene Therapy for Neurodegenerative Diseases" (ND) provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.

  • Key Changes In The Revised EMA Guidance On Clinical Trials During COVID

    In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.

  • 10 Things You Should Know About The New TMF Regulatory Guidance

    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.

  • Successful Preparation Strategies For NDA/MAA Marketing Applications

    No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.

  • 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

  • Regulatory Robotic Process Automation: The Evolution From Compliance Enablement To Compliance Automation
    1/26/2021

    During the last 20 years, IT systems and software such as those used in regulatory, clinical, safety, and document management have been implemented across life sciences organizations. It has become clear that the benefits provided by the adoption of software and systems in the life sciences industry have reached a plateau. In this executive brief, we draw on our extensive experience helping leading pharmaceutical companies worldwide gain significant time and cost savings by implementing robotic process automation designed specifically for life sciences.

  • Making The Asia-Pacific Region A Destination Of Choice For Oncology Clinical Trials
    8/8/2022

    Explore the growth of oncology clinical trials in APAC countries and strategies to support global study success in this dynamic and complex region of the world.

  • Leveraging A Central IRB Office To Improve Turnaround Times And Consistency
    3/30/2021

    With over 100 sites in the Academic and Community Center Research United (ACCRU) research network, utilizing a central IRB office was essential to increase review consistency and turnaround times.

  • The Regulatory Landscape Of Software As A Medical Device
    3/29/2021

    A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare data with the goal of improving health by utilizing analytics to manage and optimize health outcomes. However, this rich field of technology is evolving more quickly than regulators can keep up. In this webinar, the panelists will define what is considered a SaMD and explore key strategies to bring it to market successfully through regulatory strategy, clinical impact and considerations for patient engagement and participation.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.

  • 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.

  • 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.

  • Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.

  • Streamline your regulatory process and think beyond the binder. Save time, improve workflows, and enhance regulatory compliance across your organization with a system designed for academic institutions managing a large volume of protocols.