Regulatory Insights

41. 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.

42. How Leveraging Cross Collaboration Can Improve Standardization & Adoption Of An eRegulatory Solution 6/25/2020

    The University of Cincinnati Cancer Institute (UCCI) collaborated with the UC Health Office of Clinical Research (OCR) to rollout an eRegulatory system based on an NCI Standard from Complion. This allowed for enhanced compliance with ability to identify trends and gather quality metrics across UCCI Disease Groups and OCR Departments to inform business decisions and process improvements.

43. Why And How Global Healthcare Product Regulators Are Joining Forces 3/13/2020

    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.

44. How Should You Prepare For Foreign FDA Inspections During COVID-19? 2/25/2021

    As the COVID-19 pandemic continues, it is important to understand the expectations of regulators about how to facilitate paper-based facility inspections in lieu of those performed on site.

45. Global SUSAR Distribution: Lack Of Regulatory Harmony Puts Trials At Risk 5/21/2021

    The lack of global regulatory harmonization undermines safety reporting efforts, putting patients at risk and adding millions of dollars to the cost of a trial. We’ve seen at least 40 different approaches in terms of how countries handle SUSAR distribution—and it all changes regularly. It is difficult to conduct this global process correctly and the consequences of making mistakes are severe, including potential risks to patient health, regulatory repercussions, delays, or even having a trial shut down.

46. Centralized IBC Review Benefits On Research 4/1/2020

    Gene therapy research is beginning to boom in the clinical setting. This blog summarizes the growth, risks, and regulatory requirements for gene therapy research.

47. Comparative Analysis For Non-IND Sites 4/1/2020

    A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
    coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

     

48. The Challenges Of eCTD Implementation In Small Company And Academic Settings 3/6/2020

    This webinar recording will give an overview of challenges and successes of implementation of eCTD in both a small biotech setting and in academia, as these areas of industry face additional challenges that most midsize and large companies may not have.

49. Maintaining Trial Integrity During COVID-19: Some Statistical Rules Of Thumb 5/6/2020

    The COVID-19 pandemic is having a substantial impact on many ongoing clinical studies in all phases of product development. It is important to understand how to address amendments to key elements of efficacy data collection, assessment, and/or analysis.

50. Establishing A Culture Of Inspection Readiness 7/7/2020

    Inspection readiness is not simply something you do; it is a state of operation. It is optimal good clinical practice and an ongoing organizational discipline. Learn the processes that must be completed to establish a culture of inspection readiness.