Patient Data Reporting Featured Articles

31. You're A Small Biotech — How Should You Implement A Pharmacovigilance System? 1/28/2021

    When it comes to implementing strong PV practices at your company, there are a variety of components and capabilities to put in place. I’ve been on both the Big Pharma and biotech sides of this debate. With this knowledge in hand, I can help answer some of the commonly asked questions raised about PV best practices.

32. Harmonizing Clinical Trial Content In A Post-Pandemic World 1/19/2021

    For clinical trial transformation to achieve its full potential, the structure and content of clinical trial documents must change to facilitate data transfer, content reuse, and predictability of information flow to support more efficient trial conduct by sites and sponsors.

33. Best Practices For Implementing Decentralized Clinical Trials 1/12/2021

    While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

34. Tread Carefully Into Virtual Clinical Trials 12/21/2020

    With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so. 

35. ICH E6(R3) – Opportunities For Collaborative Alignment Between Stakeholders On eSource & RWE Priorities 12/8/2020

    During the 2020 Avoca Quality and Innovation Summit, an interactive brainstorming system was used during a workshop on ICH E6(R3) to gather industry executives’ insights about guidance that would more rapidly and effectively enable quality adoption of innovative trial designs and technology

36. 3 Steps To Get A Virtual Clinical Trial Up And Running 10/20/2020

    Despite the existence of innovative technologies, they are only one piece of a complicated puzzle needed to successfully implement virtual clinical trial models. It’s critical that sponsors also consider these three key steps for achieving sustainable change in the bold, patient-centric move to virtual clinical trials.

37. 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.

38. 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.

39. 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.

40. 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.