“Thousands and thousands of people” will be using the EU clinical trials portal and database after it goes live late next year and the European Medicines Agency plans to “invest a lot” this year in teaching trial sponsors and EU member state authorities how to use the new system. The EMA is also still working on ironing out the tricky areas of user management and how to transition legacy trials.
Drug sponsors and European authorities will be able to start learning how to use the forthcoming EU clinical trial portal and database later this year, according to the European Medicines Agency, which has also revealed it is still on schedule to deliver the new system in October 2018.
“Training for the EU portal and database will be available during the second half of 2017 for the version of...
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
