Featured Editorial
-
Correct But Misleading: AI Hallucinations In Complex Decision-Making
7/11/2024
Managing risks associated with AI hallucinations requires "explainability," a process that identifies patterns or behaviors in AI models that are inconsistent with training data or logical expectations. Regulators are mandating transparency in AI models used for drug testing and development.
-
Could GenAI Dramatically Reduce The Cost Of Regulatory Medical Writing?
7/3/2024
Time-poor regulatory professionals stand to benefit substantially from generative AI, which can speed up the creation of marketing authorization applications or life cycle maintenance activities, for example. However, success will depend on how the technology is applied and controlled.
-
Takeda Chooses Wearable To Improve Patient Experience & Data In Sleep Study
6/27/2024
Takeda Head of the Orexin Franchise Development and Neuroscience Portfolio Strategy Elena Koundourakis explains why her team decided to pursue the use of DHTs and the benefits of doing so, for both the patients and the data accuracy.
-
What Drives eConsent Adoption? Reasons May Be Different Than You Think
6/13/2024
Increasing efficiency and reducing cost are significant drivers for adopting eConsent platforms. But are they really the factors holding back widespread adoption? Gatewood Global Principal Jeanie Magdalena Gatewood reveals other drivers in her independent research.
-
Unlocking Next Generation Clinical Trials Through Data Sharing & Tech-Driven Approaches
5/21/2024
New findings from a survey conducted in the U.S. indicate a significant number of trial participants are eager to have their data used by researchers. How can biopharma companies harness this?
-
Meaningful Industry Change Means Balancing Tech And Human Touch
5/6/2024
Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.
-
What Can Digital Patient Twins Do For Clinical Research?
4/29/2024
Digital patient twins have the potential to vastly improve our current healthcare systems by offering personalized therapeutics, enhanced health monitoring, and streamlined pharmaceutical manufacturing, including clinical trials.
-
ICH E6(R3) And Defining What Is Critical To TMF Quality
4/9/2024
By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
-
A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
-
3 Tips For Selecting Your eTMF Platform
3/7/2024
Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.