INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • Ask The IRB Experts
    Ask The IRB Experts

    Clinical research is complicated.  At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.

  • Changes to WHODrug Are Coming – Will You Be Ready?
    Changes to WHODrug Are Coming – Will You Be Ready?

    Why you should prepare now even with nearly a year remaining.

  • Lay Summary Development—The Oregon Trail Of Regulatory Writing
    Lay Summary Development—The Oregon Trail Of Regulatory Writing

    The world of lay summaries is a bit like the Oregon Trail, where authoring and review processes have yet to be navigated by many study sponsors. Impending regulation throws study teams into the Wild West of regulatory documentation, where they are forced to use available resources to keep up with legislation. What happens when resources are limited or the path is unclear?

  • How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency
    How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency

    With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.

  • DIA Now Product Demonstration

    A video overview of the valuable content that can be accessed as a DIA NOW user.

  • Understanding FDA’s Priority Review Voucher System

    How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.

  • Virtual Clinical Trials Best Practices

    In recent years, alongside the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials.  This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.

  • Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle

    The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. This Webcast provides an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. Hot topics such as Brexit, combination products, E2B(R3), EVDAS/eRMR, medical device regulations, and IDMP are also included.

  • The Top 5 Questions To Ask When Developing A REMS

    Unsure if a REMS is needed during product development? This article will answer that question and give guidance if implementing a REMS is necessary.

More Insights On Clinical Trial Regulatory Issues

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Electronic Regulatory & Study Binders
    Electronic Regulatory & Study Binders

    All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders.

  • DIA 2019 Annual Meeting Schedule At A Glance

    Download the at a Glance Schedule for DIA 2019 Global Annual Meeting - San Diego - June 23-27.

  • Global Multilingual Call Center
    Global Multilingual Call Center

    TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).

  • Global Pharmacovigilance And Safety 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.

  • Study Start Up
    Study Start Up

    One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.

More Clinical Trial Regulatory Solutions