Regulatory Insights

31. 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.

32. Phlexglobal Innovation Tour 2020: Industry Survey Results & Expert Analysis 1/25/2021

    On July 15, 2020, we launched the Phlexglobal Innovation Tour to bring together experts from across our industry to discuss clinical and regulatory related topics and explore innovative approaches to making compliance faster, easier, and better. What follows are the results of focused audience polls done during each session and afterwards together with the thoughts of our Innovation Tour experts

33. Successful Submission Of A Complex NDA For A Breakthrough Therapy- Designated Product 6/11/2021

    Successfully submitting an NDA is more than just checking the boxes; it requires a foundational regulatory and clinical strategy that can adapt to the challenges and competing priorities of the drug development process and ultimately drive the program forward. To guarantee meeting a recent tight NDA submission timeline, we relied upon our regulatory expertise and clinical trial acumen.

34. Snapshot: A New Guidance Document Program From The FDA 4/21/2020

    In a progressive effort to mitigate these long-standing concerns and bring a level of clarity to its guidance documents, the FDA has created a pilot program called “Guidance Snapshots.” As experts, we are always debating about what the guidance is asking and how the contents are to be applied.

35. 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.

36. COVID-19 Regulatory Developments Impacting Technology Use In Clinical Trials 5/5/2020

    In light of the recent disruptions and challenges posed by COVID-19, there has been an increase in activity in promoting the use of technology in clinical trials. This blog reviews recent statements from the FDA (US Regulator), MHRA Inspectorate (UK Regulator), various Institutional Review Boards (IRBs), and ACRO (Association of Clinical Research Organizations) regarding the current situation.

37. 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?

38. Pitfalls Of Chemistry, Manufacturing, And Controls In Investigational New Drug Preparation 6/11/2021

    Developing an investigational new drug (IND) application is a big milestone for organizations. Too often, though, the chemistry, manufacturing, and controls (CMC) aspect of the IND are not fully considered until it is too late, resulting in a delayed IND submission or even a clinical hold letter from the Food & Drug Administration (FDA). To understand more about how these roadblocks may impact an IND, this blog outlines three common CMC pitfalls.

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. Guidance For Remote Monitoring For Sponsors And CROs 5/1/2020

    Guidance for implementing remote monitoring as a broad policy at the site level. In light of COVID-19, Veeva proposes that sites and sponsors take a risk-based approach to updating policies and study documents to include only critical elements needed in order to implement remote monitoring quickly while not introducing administrative burden on teams.