With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.
In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.
There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.
We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.
COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.
During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.
During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.
While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.
As we face our latest pandemic threat, the need to have a well-defined and tested business continuity management plan in place cannot be overemphasized. Beyond state and national preparedness plans, organizations should be actively evaluating their continuity plans, especially when it comes to strategic contract service providers and partners, to ensure there is a reasonable mitigation plan in place.