Regulatory document quality is of the utmost importance in the pharmaceutical, biotechnology, and medical device industries to ensure data accuracy and provide confidence in drawing reliable conclusions. A great quality control process ensures that the writing is...
The European Medicines Agency (EMA) recently announced the European Union (EU) Portal, a database for obtaining a clinical trial authorization, will be activated by the end of January 2022. The EU Portal will trigger the enforcement of the EU Clinical Trial...
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Thursday, October 22, 2020, to discuss the development, authorization, and/or licensure of vaccines to prevent COVID-19. The committee heard from...
[Fill out the form below to register] Abstract: The Global Clinical Research Organization (CRO) market is expected to grow to $71.7 billion in 2024. Within that growth, Functional Service Provider (FSP) relationships are expected to grow at a CAGR of 5%-6%. Sponsor...
Remote audits are crucial for auditors and auditees in the pharmaceutical industry to help reduce health risks since the advent of the COVID-19 global pandemic. On-site inspections across pharma and other industries may not be possible due to multiple factors,...
[Fill out the form below to access the whitepaper] The Orphan Drug Act, established in 1983, provides incentives to sponsors for promoting the development of drugs for the prevention, diagnoses, and treatment of rare diseases or conditions that affect fewer than...
Note: To use the dashboard, read the article below, then click the arrows on the dashboard to enter full screen mode. Use the dashboard to find the prevalence of COVID-19 among tested individuals within your region of interest. Then, adjust the sensitivity,...
By MMS Holdings and TrialAssure [Fill out the form below to access the whitepaper] While global regulatory authorities routinely update clinical trial disclosure and transparency requirements, new regulations set to take effect in 2020 and 2021 will dramatically...
[Fill out the form below to register] In the wake of the COVID-19 pandemic, governments across the globe have rushed to implement countermeasures and develop best practices to curtail the spread of the virus, impacting the conduct of clinical trials in unprecedented...