Regulatory Insights

  1. When Other CROs Said No, We Said Yes — To The Nearly Impossible 7/30/2019

    The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

  2. eRegBinders - Opportunities For Improvement Identified By Sites 7/10/2020

    Regulatory compliance represents an increasingly demanding and difficult task for investigative sites. A recent survey comes at the perfect time to quantify this burden, identify the infrastructure to manage this burden as well as provide practical opportunities for improvement based on best practices.

  3. Lay Summary Development—The Oregon Trail Of Regulatory Writing 8/15/2019

    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?

  4. FDA's Project Orbis: Trendsetter Or One-Off 11/6/2019

    With the announcement of Project Orbis, FDA’s Oncology Center of Excellence (OCE) excited both patients and the pharmaceutical industry with the program’s future possibilities for collaborative regulatory authority interaction in accelerating product approvals worldwide. So the question immediately comes to mind as to whether this is the tip of the iceberg for process improvement for future coordinated international regulatory marketing approvals or is this an isolated incident where all the stars were aligned.

  5. IND Best Practices: 5 Tips For A Successful Filing 1/6/2021

    There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.

  6. Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring 9/8/2020

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  7. What Level Of Review Does Your Study Need? 1/21/2020

    The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.

  8. Risk Evaluation And Mitigation Strategy (REMS) Overview 4/29/2019

    UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.

  9. What Is FDA’s Emergency Use Authorization (EUA) And How Can It Help Develop Therapies Faster? 3/25/2020

    As we continue to face health emergencies and imminent threats to our safety and well-being, the medical community is tasked with bringing solutions to the patients in an expedited and safe manner. One such opportunity is to partner with the US FDA by submitting an Emergency Use Authorization (EUA) for any products that could immediately and effectively address a health emergency.

  10. Mapping The New Landscape Of Orphan Drug Development 2/4/2020

    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.