Featured Editorial

31. ClinOps Digital Transformation: Tips For Getting It Right The First Time 1/5/2024

    Despite the digital “revolution” being more than 70 years old, digital transformation continues and mistakes are still being made. But that does not need to be the case.

32. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

33. An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development 10/30/2023

    The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.

34. Can DCTs Be Both Patient Centric And Financially Efficient For Sites? 9/22/2023

    While DCTs have the potential to provide more convenience and improved access for patients, the anticipated cost savings touted for these trials have yet to materialize fully at the site level. In fact, the opposite has occurred in some instances.

35. Navigating The Hype Of AI In Clinical Research 9/18/2023

    When you consider the rising cost of healthcare in America, a shortage amounting to tens of thousands of physicians, and economic headwinds stirring fear across the field, we can’t afford to not use AI. We shouldn’t be asking ourselves questions of why, but rather, why not. But that begs a new question: Why haven’t we seen the impact, adoption, and value of AI more broadly across clinical research?

36. Establishing TMF Quality Goals For Greater Trial Efficiency 9/14/2023

    Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Consultant Ken Keefer discusses the importance of creating TMF quality goals to improve overall trial performance.

37. RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3) 9/12/2023

    Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct. 

38. How To Accelerate Digital Clinical Transformation Through A Holistic Approach 8/31/2023

    Only one third of companies that have started a digital transformation journey has witnessed the expected ROI/revenue benefits. In the successful cases, a holistic, integrated approach created the transformational value. Explore the 10 key enterprise capabilities for successful digital clinical transformation.

39. Embracing Hybrid Trial Design — How, When, & Why To Use It 6/28/2023

    Global Clinical Sciences & Operations Innovation Lead Lewis Millen talks about UCB’s approach to hybrid trial design, how and when it chooses to implement remote and virtual elements, and why a hybrid trial is beneficial to both the sponsor and the patient.

40. Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities 6/23/2023

    One of the chief benefits of applying RWD for rapid signal assessment is that it can provide a more accurate view of outcomes that should be expected within a given clinical scenario. However, before RWD’s maximum potential for rapid signal assessment can be reached, the industry must overcome some sizable challenges. Amgen's Vaishali Patadia explains.