Regulatory Insights
-
Exploring The Landscape, Modalities, And Logistics Of CGTs
1/31/2024
Explore the latest market trends and the nuances of various cell and gene therapy modalities, along with the logistical considerations necessary to safeguard product quality and safety.
-
Perspective On The FDA's Final Digital Health Technologies Guidance
1/24/2024
Review the final release of "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”, where the FDA acknowledges DHT value and the increasing use of them in clinical trials.
-
Top 5 Insights From FDA Workshop On Enhancing Trial Diversity
1/24/2024
Read about how this workshop served as a reminder of the need for diversity in patient recruitment and the shared commitment across the spectrum of clinical trial stakeholders.
-
Exploring The Interactions Between Validation, Technology Transfer
1/24/2024
Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.
-
Operationalizing Disclosure Intelligence For Compliance At Scale
1/19/2024
Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.
-
What Does The New FDA DHT Guidance Mean?
1/18/2024
In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.
-
Understanding Safety Tactics, Regulatory Considerations In JAPAC
1/12/2024
As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance.
-
How MAC Clinical Research Innovates With CDMS/EDC
12/27/2023
Discover how a partnership with one of Europe’s largest contract research organizations exemplifies the crucial role that technology plays in the realm of clinical studies.
-
Strategies To Unlock Excellence In DHT Clinical Trials
12/26/2023
Gain insight into how technology affects patients, critical considerations for selecting the right partners, and potential hurdles in digital health technology trials.
-
2024 Safety And Regulatory Compliance Trends And Predictions
12/26/2023
The introduction of artificial intelligence and machine learning into pharmacovigilance, safety, and regulatory workflows stands to have a major impact on process efficiency and employee workloads.