Regulatory Writing – An Integral Part of Clinical Research
Regulatory Writing is used to create a variety of clinical documents. Such clinical trial documentation includes clinical study reports. Learn more
Regulatory Writing is used to create a variety of clinical documents. Such clinical trial documentation includes clinical study reports. Learn more
Remote monitoring in clinical trials has never been so popular. This article explains a risk-based approach to remote monitoring and remote SDV
Stay up to date with the latest statistics and scientific resources on the novel coronavirus (covid-19) pandemic
Quanticate looks at some of the challenges and pharmacovigilance regulations the industry faces since 2012 with the introduction of GVPs, Brexit and ICH E2B(R3)
A patient-reported outcome is a health outcome reported by the patient who experienced it, about how they feel in relation to a health condition and its therapy
Learn more about the recent trends in biosimilar development, the FDA guidance on biosimilars, and how clinical trial designs need to adapt accordingly
An infographic that looks at the history of Pharmacovigilance and its evolution over the 20th century in response to serious adverse events and patient safety
A Quanticate blog exploring the use of consumer-grade mHealth apps and wearables in clinical trials and the most recent regulations on mobile health
Watch Ben Goldacre discuss Clinical Trial Transparency and 'AllTrials: Transparency is moving forwards, the pharmaceutical industry can benefit from doing the right thing'
A Quanticate blog exploring The Black Triangle symbol ▼ and Additional Monitoring in the new Pharmacovigilance legislation.