Computerised Systems and Electronic Data in Clinical Trials play critical roles in data management, analysis, and reporting. And the systems used in clinical trials have evolved rapidly in recent years from electronic Case Report Forms (eCRF) and electronic Patient...
Corrective Action and Preventive Action (CAPA) is a process which investigates and solves identified issues by evaluating the causes and taking corrective action to resolve immediate issues. To be ISO 9001 and ISO14001 certified, companies must have a Corrective...
Psychedelic drug development is quickly becoming a new frontier in the pharmaceutical industry. On June 23, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance document outlining important considerations for researchers and drug sponsors...
There are more than 2,800 CRO’s according to IBISWorld and choosing the right partner can be a difficult choice for clinical trial sponsors looking for the right data management resources. Current and upcoming pipeline projects are critical, and it’s hard to just...
With the initial release of the Clinical Trial Information System (CTIS) in January 2022, a digital space was created for the implementation of the EU Clinical Trials Regulation (EU CTR) 536/2014, the law governing the conduct of clinical trials in the EU. A period of...
By 2043, the cost to brings a new drug to market is estimated to be USD16 billion per compound, according to Moore’s Law. This is partly due to clinical trials becoming more complex and requiring longer follow up timeframes during studies. To mitigate the cost impact,...
Are you looking for rapid feedback from the FDA on a specific topic related to your product development program? Wondering which meeting request you should submit? Let’s delve into the latest updates. On September 22, 2023, the FDA released the eagerly anticipated...
Plain Language Summary for Publications (PLS‑P) is a document born from the growing need to make scientific research and information more understandable to a broader audience. Technical language and terminologies used in scholarly articles can act as a barrier to...
Phase 1 clinical trials occurred in 2,784 instances, accounting for nearly 41 percent of all clinical trials globally, according to recent 2022 data (source). In general, there are more Phase 1 clinical trials than Phase 2 or Phase 3 due to the exploratory nature of...