INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • Different Approaches For Preparing A Marketing Application

    In this webinar experts explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and coordinate with the medical writing team so that all the information needed to write and complete the modules of the submission is provided with adequate time for review and quality control.

  • Mapping The New Landscape Of Orphan Drug Development

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

  • FDA’s Sentinel System: Strategies For Expansion And Transformation

    The FDA Sentinel System started as a congressional mandate in the FDA Amendments Act of 2007 and has given rise to one of the world’s premier evidence generation platforms. Read how this system is continuing to be invaluable and is a testbed for future projects.

  • A New Era In Dermatology: Study Design, Regulatory Strategies, And Patient Participation

    This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical elements when devising effective recruitment and retention strategies.

  • 5 Strategies For APAC Drug Submissions: Korea, China, Japan
    10/25/2019

    Korea, China, and Japan are no strangers to clinical trials in Asia. They have large patient populations and sophisticated regulatory systems and infrastructure, and each has worked to adopt the CTD or eCTD for submissions. That said, they also require the most content to be presented in-language to local regulators. So how do you manage up to five million words of critical content translation across 330 files and submit on time?

  • Updates To The Guideline For Good Clinical Practice: Quick Review
    3/30/2020

    In November 2016, for the first time in 20 years, ICH GCP was updated by means of an addendum that provides additional guidance without altering the existing text. Now that we are in the implementation phase of the ICH GCP revision, it may be a good idea for biotech and specialty pharma innovators to review the key principles of ICH GCP and how they have been updated to reflect the realities to today’s clinical trial landscape

  • 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.

  • DIA NOW Sample Video - FDARA Section 504
    8/20/2020

    FDARA Section 504 eliminated the orphan exemption for pediatric studies for cancer drugs and instead empowers the FDA to require pediatric assessments of new therapies.

  • Unsustainable And Burdensome: Today’s Safety Reporting Fails Sites, Sponsors And Patients
    5/21/2021

    Safety reporting is one of the last areas of hidden cost and inefficiency in clinical trials today, costing sponsors millions or tens of millions of dollars each year in excessive site payments and monitoring costs on unnecessary or duplicate safety reporting. Few receive value for their investment, and some don’t even know how much that investment is.

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.

  • As life sciences companies move to semi-virtual environments keeping only the most vital functions in house, more and more Trial Master Files are being converted to an eTMF format.

  • Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.

  • When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.

  • As you begin your journey to adopting an eRegulatory solution, choosing which system to adopt can seem like a daunting task. How can a first-time buyer sort through the bells and whistles to parse out what elements are truly necessary?