INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • Success Strategies For Conducting Clinical Trials During The COVID-19 Pandemic

    Our agile and scientific-minded experts have compiled a guide of critical strategies for clinical development success during the COVID-19 era. Download the guide to explore key strategies for maintaining momentum, assessing your risks, and minimizing  delays for ongoing, new, and COVID-19 related trials.

  • When RIM Is Not Enough: Overcoming The Limitations Of Document-Driven Systems

    Explore the next stage of regulatory information management. It's time to move past electronic versions of old paper-based processes and see the efficiency that comes with a data-focused approach.

  • Why And How Global Healthcare Product Regulators Are Joining Forces

    The ICMRA is now considered a strategic cross-border leader among a select group of global medicine and device regulatory policy bodies. Read how the coalition is working across the world to help sponsors develop medical products in a more globally harmonized way moving forward.

  • Current Challenges (And Solutions) In Global Regulatory Harmonization

    According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. Larger harmonization agreement efforts, even with intervention by the World Health Organization (WHO), ended many times when country regulators bickered over who had the power to develop the standards and whose standards should be followed. The ICMRA, ICH, and other affiliated harmonization groups are acting to correct this.

  • A Summary Of FDA Guidance On COVID-19: Patient Safety And Adapting Processes
    4/13/2020

    Recently, the FDA released some guidance to help study teams make decisions, as well as handle the documentation regarding related changes to their operations and protocol. Here is a quick, itemized rundown of their guidance for ongoing trials (focused on Discussion Section A of the guidance), each followed by some commentary to provide additional food for thought.

  • 505(B)(2) Planning: Regulatory And Study Conduct Best Practices
    7/15/2020

    Watch this on-demand webinar to hear experts from Worldwide Clinical Trials and Camargo cover the latest trends and early planning recommendations for building and executing a successful 505(b)(2) development program.

  • The Case Of The Elusive Protocol
    2/3/2020

    A client required a chart review to evaluate survivability of pediatric patients with a rare metabolic bone disorder. By trying different protocols and overcoming complex issues of informed consent that had to be resolved before the study was successfully completed, they were able to successfully deliver a final clinical study.

  • Meridian Builds Robust Gene Therapy Research Program By Leveraging Advarra IBC Services
    3/30/2021

    Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Download the case study.

  • INTERACT Meetings: Streamlining Early Clinical Development
    3/9/2020

    Read how the INTERACT meeting can be an invaluable engagement with the agency to inform the successful planning and execution of a novel product development program.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • PhlexxEVMPD is designed to support the collection, reporting, coding and evaluation of your medicinal product data in a standardized and structured way. Compliant with Article 57, PhlexxEVMPD is a great and easy way to start managing and owning more and more of your data in a digitalized fash

  • Contracting an in-country clinical depot helps bring costs and timelines under control.

  • 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.

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

  • Comprehensive Phlexglobal Regulatory Information Management (PhlexRIM) will help the life sciences organizations effectively and efficiently drive the development, capture, dissemination, control and management of regulatory focused information throughout the product lifecycle.