EMA reminds the clinical trials community that the Clinical Trials Information System will be mandatory at the last day of this month.
On January 31, 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trials applications and will serve as the single-entry point for submission by sponsors and for regulatory assessment. The EMA reiterated this deadline and updated the community on the current status of the system, which has been in transition for one year.
Read additional information from the EMA.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.