Patient Data Reporting Featured Articles

41. Safeguarding Participant Data During Risk-based Monitoring — Practical Considerations 9/22/2020

    With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data.

42. What Is Your AI Road Map To Revolutionize Drug Development? 9/8/2020

    When it comes to artificial intelligence (AI), many organizations do not know where to start or waste their energy going in many directions without a clear vision. This article will share insights on how to pragmatically initiate an AI journey using the evolution of clinical data management as an example.

43. Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations 6/30/2020

    In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.

44. Healing From A Pandemic And Building Resilience Into Future Clinical Trials 6/23/2020

    We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

45. COVID-19 & The Virtual Trial Rush: Front-Line Insights 5/19/2020

    The COVID-19 pandemic caught many sponsor companies and sites unprepared. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.

46. Move Virtual Trials From Aspiration To Reality In Today's Environment 5/14/2020

    With the COVID-19 pandemic upon us, we are at a place where the business case is clear, the barriers to adoption are largely removed, and sites and participants alike have begun accepting virtual trials as not just an option but a must.

47. eConsent In Clinical Trials: Insights For Implementation During COVID-19 And Beyond 5/7/2020

    The world has changed in the wake of COVID-19. To adjust, clinical trial sponsors must adapt their protocols, and many are urgently doing so, to provide virtual tools for clinical trial use. One example of an important tool in this space is electronic consent, or eConsent.

48. Clinical Trials At Home — Implementing Telemedicine & Virtual Visits During COVID-19 4/27/2020

    There is no denying that the COVID-19 pandemic has spurred tremendous — and fast — innovation across our industry. Most importantly, the expansion of telemedicine and virtual solutions is enabling us to meet our patients’ needs while also maintaining patient safety, study integrity, and data quality.

49. How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials 3/31/2020

    It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.

50. Clinical Operations In The Age Of A Pandemic 3/12/2020

    The Beat AML (BAML) Master Clinical Trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data, while preparing for another outbreak or weathering the current crisis.