A new survey of investigator sites reveals approximately 69 percent of respondents said lockdown measures have impacted their ability to conduct ongoing trials and 78 percent said COVID-19 has affected their ability to start new trials. Read More
The COVID-19 Collaboration Platform (COVIDCP), a new initiative from universities and clinical trial organizations across the U.S., will bring together research teams who are working on vaccines and treatments for COVID-19. Read More
Pharma companies and CROs are experiencing ups and downs in the second quarter of 2020, with some fighting to keep their trials afloat amidst pandemic uncertainties while others are slowly getting back on track. Read More
A working group of the World Health Organization (WHO) has indicated its support of COVID-19 vaccine challenge studies, but made it clear that those trials must meet eight conditions for them to be considered. Read More
The worldwide rush demanded by the pandemic to develop and/or identify a potential treatment or vaccine has culminated in remarkable success in expediting COVID-19 trials, and the lessons learned are likely to be applied even after the pandemic is over. Read More
Just two years after releasing a major revision of its good clinical practice (GCP) guideline, the International Council on Harmonization (ICH) is planning a new update that would require additional adjustments from sponsors and sites that still may be trying to catch up with the first revision. Surprisingly, the COVID-19 pandemic could end up making that task easier. Read More
The European Commission and European Medicines Agency (EMA) as well as the Heads of Medicines Agencies (HMA) have added new recommendations on distribution, monitoring, remote source data verification (SDV) and communication with authorities to their guidance on managing trials during COVID-19. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) has released new recommendations to ensure efficient regulatory processes that will support the development of diagnostics and treatments for COVID-19. Read More
As pharma companies report on first-quarter earnings, most appear hopeful that they can limit the impact of the pandemic on their current trials and return to near-normal conditions by the end of the year. Here’s a sampling of what happened last week: Read More
RSS
