Regulatory Insights

31. 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.

32. Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle 6/19/2019

    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.

33. Are You Really Ready For Your End Of Phase 2 (EOP2) Meeting? 4/21/2020

    The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission.

34. Virtual Clinical Trials Best Practices 10/16/2019

    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.

35. Rare Disease: Operationalizing Gene Therapy Trials 10/9/2019

    Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. This paper explores the history of gene therapy trials, as well as the types of gene therapy vectors and delivery strategies. Also discussed is the regulatory and operational challenges associated with gene therapy trials, including start-up regulations, site selection, recruitment, and retention.

36. COVID-19 Treatment Development: Updates And Recent FDA Guidance 6/2/2020

    The FDA continues to release additional information and update their website as the COVID-19 pandemic continues and both regulatory professionals and drug developers react to the potential for novel and repurposed products to treat COVID-19. This blog addresses recent changes to the Coronavirus Treatment Acceleration Program (CTAP) webpage as well as two new guidance documents for the COVID-19 treatment development.

37. 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.

38. DIA NOW Sample Video - Patient Engagement Initiatives And Regulatory Approval 8/20/2020

    DIA NOW Sample video - Patient engagement initiatives are shown to increase chances of regulatory approval and accelerate development timelines.

39. The Value Of Data Standards In Clinical Trials: The Time Is Now 12/3/2019

    On an organizational level, failure to establish data standards upfront makes it difficult – and in some cases, impossible to connect data across disparate systems for efficient study execution. The adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Continue reading to understand the history of data standards and where they are headed in the future.

40. The Top 5 Questions To Ask When Developing A REMS 3/25/2019

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